Science.gov

Sample records for fda review staff

  1. 76 FR 30175 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-24

    ... regulations governing financial disclosure by clinical investigators, part 54 (21 CFR part 54), and to provide... Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators; Availability AGENCY... FDA Staff: Financial Disclosure by Clinical Investigators.'' This draft guidance is intended to assist...

  2. Internet Database Review: The FDA BBS.

    ERIC Educational Resources Information Center

    Tomaiuolo, Nicholas G.

    1993-01-01

    Describes the electronic bulletin board system (BBS) of the Food and Drug Administration (FDA) that is accessible through the Internet. Highlights include how to gain access; the menu-driven software; other electronic sources of FDA information; and adding value. Examples of the FDA BBS menu and the help screen are included. (LRW)

  3. 76 FR 41506 - Draft Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and FDA Staff on In Vitro.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance.... This guidance defines in vitro companion diagnostic devices; explains the need for FDA oversight...

  4. 78 FR 29141 - Center for Devices and Radiological Health Appeals Processes; Guidance for Industry and FDA Staff...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-17

    ... HUMAN SERVICES Food and Drug Administration Center for Devices and Radiological Health Appeals Processes; Guidance for Industry and FDA Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance...

  5. Characteristics of pivotal trials and FDA review of innovative devices.

    PubMed

    Rising, Joshua P; Moscovitch, Ben

    2015-01-01

    When patients lack sufficient treatment options for serious medical conditions, they rely on the prompt approval and development of new therapeutic alternatives, such as medical devices. Understanding the development of innovative medical devices, including the characteristics of premarket clinical trials and length of Food and Drug Administration (FDA) review, can help identify ways to expedite patient access to novel technologies and inform recent efforts by FDA to more quickly get these products to patients and physicians. We analyzed publicly available information on clinical trials and premarket FDA review for innovative medical devices that fill an unmet medical need. In this first-of-its-kind study focusing on these products, we extracted data on the length of the pivotal trials, primary study endpoint and FDA review; number of patients enrolled in trials; and in what country the device was available first. We identified 27 approved priority review devices from January 2006 through August 2013. The median duration of pivotal clinical trials was 3 years, ranging from 3 months to approximately 7 years. Trials had a median primary outcome measure evaluation time of one year and a median enrollment of 297 patients. The median FDA review time was 1 year and 3 months. Most priority review devices were available abroad before they were approved in the United States. Our study indicates that addressing the length of clinical studies--and contributing factors, such as primary outcome measures and enrollment--could expedite patient access to innovative medical devices. FDA, manufacturers, Congress and other stakeholders should identify the contributing factors to the length of clinical development, and implement appropriate reforms to address those issues.

  6. Characteristics of Pivotal Trials and FDA Review of Innovative Devices

    PubMed Central

    Rising, Joshua P.; Moscovitch, Ben

    2015-01-01

    When patients lack sufficient treatment options for serious medical conditions, they rely on the prompt approval and development of new therapeutic alternatives, such as medical devices. Understanding the development of innovative medical devices, including the characteristics of premarket clinical trials and length of Food and Drug Administration (FDA) review, can help identify ways to expedite patient access to novel technologies and inform recent efforts by FDA to more quickly get these products to patients and physicians. We analyzed publicly available information on clinical trials and premarket FDA review for innovative medical devices that fill an unmet medical need. In this first-of-its-kind study focusing on these products, we extracted data on the length of the pivotal trials, primary study endpoint and FDA review; number of patients enrolled in trials; and in what country the device was available first. We identified 27 approved priority review devices from January 2006 through August 2013. The median duration of pivotal clinical trials was 3 years, ranging from 3 months to approximately 7 years. Trials had a median primary outcome measure evaluation time of one year and a median enrollment of 297 patients. The median FDA review time was 1 year and 3 months. Most priority review devices were available abroad before they were approved in the United States. Our study indicates that addressing the length of clinical studies—and contributing factors, such as primary outcome measures and enrollment—could expedite patient access to innovative medical devices. FDA, manufacturers, Congress and other stakeholders should identify the contributing factors to the length of clinical development, and implement appropriate reforms to address those issues. PMID:25651420

  7. 76 FR 24494 - Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-02

    .../ Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Availability AGENCY... Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling... ``Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care...

  8. 78 FR 13686 - Draft Guidance for Industry and Review Staff on Pediatric Information Incorporated Into Human...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Review Staff on Pediatric... announcing the availability of a draft guidance for industry and review staff entitled ``Pediatric... is intended to assist applicants and FDA review staff in making decisions about the placement and...

  9. A hard look at FDA's review of GRAS notices.

    PubMed

    Roberts, Ashley; Haighton, Lois A

    2016-08-01

    Generally Recognized as Safe (GRAS) substances are exempt from premarket approval; however, the standard of "reasonable certainty of no harm" is the same. In 1997, the voluntary GRAS affirmation process was replaced with the voluntary U.S. Food and Drug Administration (FDA) GRAS notice process. Under the GRAS notice process, pivotal safety data are required to be in the public domain, and consensus of safety among experts is required. FDA issues responses of "FDA has no questions", "Notice does not provide a basis for a GRAS determination", or, "At Notifier's request, FDA ceased to evaluate the notice." Of 528 notices reviewed, there were 393 "no questions letters", 17 "insufficient basis letters", and 84 "cease to evaluate letters". Of those deemed to be insufficient, most failed to meet the general recognition criteria. Only four raised questions about potential safety, of which three received a no questions letter upon providing more data. Of the 84 withdrawn notices, 22 received a no questions letter upon resubmission. In spite of criticisms, the FDA GRAS notice process is clearly defined, efficient, and cost-effective, and there have been no known public health issues following its implementation.

  10. New aquaculture drugs under FDA review

    USGS Publications Warehouse

    Bowker, James D.; Gaikowski, Mark P.

    2012-01-01

    Only eight active pharmaceutical ingredients available in 18 drug products have been approved by the U.S. Food and Drug Administration for use in aquaculture. The approval process can be lengthy and expensive, but several new drugs and label claims are under review. Progress has been made on approvals for Halamid (chloramine-T), Aquaflor (florfenicol) and 35% PeroxAid (hydrogen peroxide) as therapeutic drugs. Data are also being generated for AQUI-S 20E, a fish sedative.

  11. 21 CFR 60.20 - FDA action on regulatory review period determinations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA action on regulatory review period... SERVICES GENERAL PATENT TERM RESTORATION Regulatory Review Period Determinations § 60.20 FDA action on regulatory review period determinations. (a) FDA will consult its records and experts to verify the...

  12. FDA's conduct, review, and evaluation of inspections of clinical investigators.

    PubMed

    Turner, G; Lisook, A B; Delman, D P

    1987-01-01

    This review of the Food and Drug Administration's Bioresearch Monitoring Program focuses on the inspection of clinical investigators who study investigational drugs. The differences between routine, "for-cause," and bioequivalency/bioavailability inspections are examined, with emphasis on the responsibilities of the clinical investigator, reasons for conducting the inspections, and problems found. Important aspects of the inspection report, such as protocol adherence, records maintenance, informed consent, institutional review board approval, and drug accountability, are outlined. The disqualification and consent agreement processes for investigators with serious problems are explained. FDA policies on third-party notification and remote data entry are noted.

  13. FDA Drug Approval: Review Time Has Decreased in Recent Years.

    DTIC Science & Technology

    1995-10-01

    New drugs marketed in the United States must be approved first by the Food and Drug Administration (FDA). Approval comes after FDA has determined...reform argue that shortening the time it takes to get new drugs approved will contribute both to public health, by making effective therapies

  14. 76 FR 32367 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-06

    ... Staff: Financial Disclosure by Clinical Investigators; Correction AGENCY: Food and Drug Administration...: Financial Disclosure by Clinical Investigators.''The document was published with an incorrect docket...

  15. Agenda: EDRN FDA Education Workshop — EDRN Public Portal

    Cancer.gov

    The purpose of this workshop was to open dialogue between FDA staff that provide oversight for review of in vitro diagnostic applications and EDRN scientists currently performing clinical validation studies on cancer biomarkers. Issues related to FDA review of diagnostic tests were presented by FDA personnel. Representatives from EDRN provided details on supporting data of their validation studies and the resources developed within EDRN to facilitate such research for FDA compliance. The agenda provided here provides links to the presentations by each speaker.

  16. FDA's misplaced priorities: premarket review under the Family Smoking Prevention and Tobacco Control Act.

    PubMed

    Jenson, Desmond; Lester, Joelle; Berman, Micah L

    2016-05-01

    Among other key objectives, the 2009 Family Smoking Prevention and Tobacco Control Act was designed to end an era of constant product manipulation by the tobacco industry that had led to more addictive and attractive products. The law requires new tobacco products to undergo premarket review by the US Food and Drug Administration (FDA) before they can be sold. To assess FDA's implementation of its premarket review authorities, we reviewed FDA actions on new product applications, publicly available data on industry applications to market new products, and related FDA guidance documents and public statements. We conclude that FDA has not implemented the premarket review process in a manner that prioritises the protection of public health. In particular, FDA has (1) prioritised the review of premarket applications that allow for the introduction of new tobacco products over the review of potentially non-compliant products that are already on the market; (2) misallocated resources by accommodating the industry's repeated submissions of deficient premarket applications and (3) weakened the premarket review process by allowing the tobacco industry to market new and modified products that have not completed the required review process.

  17. FDA Safety Reviews on Drugs, Biologics, and Vaccines: 2007-2013.

    PubMed

    Cope, Judith U; Rosenthal, Geoffrey L; Weinel, Pamela; Odegaard, Amy; Murphy, Dianne M

    2015-12-01

    In 2002, Congress mandated that the US Food and Drug Administration (FDA) monitor postmarketing pediatric adverse events and present safety reports to the FDA's Pediatric Advisory Committee (PAC). These safety reviews play a critical role in the postmarketing surveillance and identification of pediatric safety issues. This article follows a previous review ending in 2007 and summarizes 6 years of recent pediatric safety reporting, recommendations by the PAC, and actions by the FDA, including labeling changes. An analysis of the FDA's PAC safety reviews performed from November 2007 through September 2013 was conducted. PAC recommendations for subsequent labeling changes, future studies, or other safety issues were reviewed. There were 6930 serious adverse event reports in 181 reviews. These findings resulted in 33 (18%) recommended labeling changes, and 21 (64%) of these changes were adopted. For 10 products, information was added to the Warning and Precautions section of the label. The PAC also discussed or recommended additional studies for certain products. This article highlights the importance of the FDA's ongoing pediatric postmarketing safety reviews of regulated products, advice from the PAC, and FDA actions in the best interest of pediatric patients. This mandated process facilitates detection of safety concerns that may not be identified in prelicensure clinical trials. It continues to identify critical safety concerns, including unlabeled adverse events, frequent off-label use, product misuse, and secondary exposures in children. Copyright © 2015 by the American Academy of Pediatrics.

  18. 2015 in review: FDA approval of new drugs.

    PubMed

    Kinch, Michael S

    2016-07-01

    The myriad new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in 2015 reflected both the opportunities and risks associated with the development of new medicines. On the one hand, the approval of 45 NMEs was among the highest ever recorded. Likewise, the diversity underlying the mechanistic basis of new medicines suggests continued broadening relative to the predominate trends of the past few decades. On the other hand, closer inspection indicates that business model decisions surrounding orphan indications and consolidation could be placing the industry in an ever-more precarious position, with severe implications for the sustainability of the entire enterprise.

  19. Exact Sciences' experience with the FDA and CMS parallel review program.

    PubMed

    Ridge, John R; Statz, Sandra

    2015-01-01

    Colorectal cancer (CRC) is the third most commonly diagnosed cancer and the second leading cause of cancer death among men and women combined in the USA. Although the benefits of early CRC detection are widely recognized, screening rates are suboptimal. Cologuard is a multitarget stool DNA screening test that offers a unique non-invasive option for CRC screening. Cologuard was the first product to be reviewed under a pilot parallel review program jointly conducted by the US FDA and the Centers for Medicare & Medicaid Services (CMS). This parallel review process shortened the overall review for Cologuard and resulted in a preliminary National Coverage Determination that coincided with FDA approval.

  20. FDA's health claim review: whey-protein partially hydrolyzed infant formula and atopic dermatitis.

    PubMed

    Chung, Carolyn S; Yamini, Sedigheh; Trumbo, Paula R

    2012-08-01

    In this review, we explain how the US Food and Drug Administration (FDA) used its evidence-based review system to evaluate the scientific evidence for a qualified health claim for 100% whey-protein partially hydrolyzed infant formula (W-PHF) and reduced risk of atopic dermatitis (AD). The labeling of health claims, including qualified health claims, on conventional foods and dietary supplements require premarket approval by the FDA. Health claims characterize the relationship between a substance (food or food component) and disease (eg, cancer or cardiovascular disease) or health-related condition (eg, hypertension). To determine whether sufficient evidence exists to support the qualified health claim, the FDA evaluated human intervention studies that evaluated the role of W-PHF in reducing the risk of AD. The FDA concluded there is little to very little evidence, respectively, to support a qualified health claim concerning the relationship between intake of W-PHF and a reduced risk of AD in partially breastfed and exclusively formula-fed infants throughout the first year after birth and up to 3 years of age. In addition, the FDA required a warning statement be displayed along with the health claim to indicate to consumers that partially hydrolyzed infant formulas are not hypoallergenic and should not be fed to infants who are allergic to milk or to infants with existing milk allergy symptoms.

  1. FDA designations for therapeutics and their impact on drug development and regulatory review outcomes.

    PubMed

    Kesselheim, A S; Darrow, J J

    2015-01-01

    New prescription drugs receive approval from the US Food and Drug Administration (FDA) based on tests establishing safety and adequate and well-controlled trials demonstrating "substantial evidence" of efficacy. However, a number of legislative and regulatory initiatives, the most recent being the breakthrough therapy designation created in 2012, give the FDA flexibility to approve drugs on the basis of less rigorous data in situations of greater clinical need. These expedited development and review pathways now contribute to a majority of all new drug approvals and have important benefits in encouraging efficient availability of transformative drugs. They also have a number of risks, including a heightened possibility that the drugs will be discovered to be ineffective or unsafe after widespread use, and confusion by patients and physicians over what it means for a product to be "FDA approved."

  2. Considerations when submitting nanotherapeutics to FDA/CDER for regulatory review.

    PubMed

    Tyner, Katherine; Sadrieh, Nakissa

    2011-01-01

    The Food and Drug Administration (FDA) does not, as yet, have specific guidances for products containing nanoscale materials. As announced in the report issued by the FDA Nanotechnology Task Force (July 2007), however, there are recommendations to various centers within the FDA to develop guidances for industry. Regardless of the lack of explicit FDA guidances, there are therapeutics currently on the market containing nanoscale materials, and additional novel nanomaterial-containing therapeutics are being developed with the hopes of being submitted for regulatory review and approval. While, for the most part, these novel nanomaterial-containing products are being evaluated using the same regulatory requirements as products that do not contain nanomaterials, it is increasingly evident that at least in the area of characterization of nanomaterials used in drug products, there may be areas where special focus is needed. Specific areas include the validity of applying small molecule principles and methodologies to nanomaterial-containing products, the effects the nanomaterial will impart to the rest of the formulation (or vice versa), and how the physicochemical properties may be impacted by biological settings. Similarly, for safety evaluation, biodistribution studies will be at the core of any evaluation of products containing nanomaterials. These biodistribution studies will, in effect, be indicative of where the nanoparticles are traveling and possibly accumulating, therefore subjecting those sites to increased likelihood of toxicological effects. This chapter focuses on questions and considerations that may arise for sponsors during product characterization, as well as considerations for the appropriate design and conduct of in vivo toxicology studies. This chapter will also review how current FDA guidances apply to nanotherapeutics.This chapter reflects the current thinking and experience of the authors. However, this is not a policy document and should not be

  3. Discrepancies in the primary PLATO trial publication and the FDA reviews.

    PubMed

    Serebruany, Victor L

    2014-03-01

    The results of major indication seeking Phase 3 clinical trials are reported at international meetings, and simultaneously published In top medical journals. However, the data presented during such dual release do not disclose all the trial findings, suffer from overoptimistic interpretations heavily favoring the study sponsor. Ironically, after the New Drug Application is submitted for regulatory approval, and when the FDA secondary reviews become available for public, the benefit/risk assessment of a new drug is usually considered much less impressive. However, the community may ignore pivotal unreported findings later outlined in the government documents taking for granted the facts presented in the primary publication. The discrepancies between initial publication and the FDA files are not only confusing to the readership, but hold additional risks for patients. Indeed, if physicians are impressed with the initial interpretation of the trial, and do not have broad access to the FDA verified facts, chances are new agents will be prescribed based on exaggerated benefit and less safety concerns. The current pattern also hurts the reputation of the journal publishers, editors and reviewers challenging their trust and credibility. We here outline the disparity between the primary PLATO trial publication in the New England Journal of Medicine against the FDA verified numbers, and discuss how to avoid such mismatches in the future.

  4. 78 FR 101 - Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-02

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  5. 77 FR 45357 - Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-31

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ] SUMMARY: The Food and Drug Administration (FDA) is...

  6. FDA’s (Federal Drug Administration) Reviews of New Drugs: Changes Needed in Process for Reviewing and Reporting on Clinical Studies

    DTIC Science & Technology

    1988-09-01

    and the reliability of test data submitted to FDA in support of new drug applications. GAO reviewed the Division’s activities, including its...responsibilities relating to the approval of new drug and biologic products; the accuracy of FDA data and adequacy of oversight regarding clinical...investigators, institutional review boards, and toxicology laboratories involved in studies supporting new drug applications; FDA’s review of studies by clinical

  7. Efficacy and safety concerns are important reasons why the FDA requires multiple reviews before approval of new drugs.

    PubMed

    Ross, Joseph S; Dzara, Kristina; Downing, Nicholas S

    2015-04-01

    The regulatory approval of new drugs by the Food and Drug Administration (FDA) is a long and complex process and often requires multiple cycles of review, potentially delaying patients' access to new and effective therapeutics. We used qualitative methods to characterize the safety and efficacy reasons why applications for novel therapeutics approved by the FDA between 2001 and 2011 required multiple review cycles prior to approval. Among ninety-six applications approved between 2001 and 2011 that required multiple review cycles, safety concerns contributed to seventy-four (77.1 percent) and efficacy concerns to forty-three (44.8 percent). Our study suggests that multiple review cycles appear to play an important role in allowing the FDA to protect public health and in ensuring adequate understanding of clinical benefits and risks prior to approval.

  8. A review of US EPA and FDA requirements for electronic records, electronic signatures, and electronic submissions.

    PubMed

    Keatley, K L

    1999-01-01

    Both the United States Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) have issued regulatory documents that address the issues and requirements concerning electronic reporting to the Agencies. EPA has published two comprehensive and useful electronic data interchange (EDI) guidelines: 1) the EPA Electronic Data Interchange (EDI) Implementation Guideline, Draft of September 23, 1994 and October 18, 1994 that is available at the following EPA web site address: www.epa.gov/oppeedi1/guidelines/general.pdf and 2) the Interim Final Notice, Filing of Electronic Reports via Electronic Data Interchange, September 4, 1996, Federal Register Notice [FRL-5601-4, Volume 61, Number 172, page 46684], also available at: www.epa.gov/oppeedi1/edipoli.htm. The FDA has published a guidance document titled, "Guidance for Industry, Computerized Systems Used in Clinical Trials, April 1999" that is available at FDA's web site: www.fda.gov/ora/compliance_ref/bimo/ffinalcct.++ +htm. FDA's guidance document addresses a number of issues for electronic records that are applicable to all areas of GLP compliance. Another FDA document presently under development is titled, "Electronic Standards for the Transmission of Regulatory Information (ESTRI) Gateway." The ESTRI document defines strategic plans for electronic submissions to FDA. FDA has published a guidance document in this area titled, "Guidance for Industry: Providing Regulatory Submissions in Electronic Format--General Considerations, January 1999." This guidance document is available at: www.fda.gov/cder/guidance/index.htm. FDA has also published an important final rule applicable to all electronic records and signatures that is part of the U.S. Title 21 Code of Federal Regulations (CFR), Part 11, titled, "FDA's Final Rule, Electronic Records; Electronic Signatures, effective August 20, 1997." This FDA ruling is discussed below and is available at: www.fda.gov/cder/esig/index.htm.

  9. EBOLA and FDA: reviewing the response to the 2014 outbreak, to find lessons for the future

    PubMed Central

    Largent, Emily A.

    2016-01-01

    Abstract In 2014, West Africa confronted the most severe outbreak of Ebola virus disease (EVD) in history. At the onset of the outbreak—as now—there were no therapies approved by the U.S. Food and Drug Administration (FDA) for prevention of, post-exposure prophylaxis against, or treatment of EVD. As a result, the outbreak spurred interest in developing novel treatments, sparked calls to use experimental interventions in the field, and highlighted challenges to the standard approach to FDA approval of new drugs. Although the outbreak was geographically centered in West Africa, it showcased FDA's global role in drug development, approval, and access. FDA's response to EVD highlights the panoply of agency powers and demonstrates the flexibility of FDA's regulatory framework. This paper evaluates the strengths and weaknesses of FDA's response and makes policy recommendations regarding how FDA should respond to new and re-emerging public health threats. In particular, it argues that greater emphasis should be placed on drug development in interoutbreak periods and on assuring access to approved products. The current pandemic of Zika virus infection is but one example of an emerging health threat that will require FDA involvement in order to achieve a successful response. PMID:28852537

  10. Assessing the Quality of Economic Evaluations of FDA Novel Drug Approvals: A Systematic Review.

    PubMed

    Woersching, Alex L; Borrego, Matthew E; Raisch, Dennis W

    2016-12-01

    To systematically review and assess the quality of the novel drugs' economic evaluation literature in print during the drugs' early commercial availability following US regulatory approval. MEDLINE and the United Kingdom National Health Service Economic Evaluation Database were searched from 1946 through December 2011 for economic evaluations of the 50 novel drugs approved by the FDA in 2008 and 2009. The inclusion criteria were English-language, peer-reviewed, original economic evaluations (cost-utility, cost-effectiveness, cost-minimization, and cost-benefit analyses). We extracted and analyzed data from 36 articles considering 19 of the 50 drugs. Two reviewers assessed each publication's quality using the Quality of Health Economic Studies (QHES) instrument and summarized study quality on a 100-point scale. Study quality had a mean of 70.0 ± 16.2 QHES points. The only study characteristics associated with QHES score (with P < 0.05) were having used modeling or advanced statistics, 75.1 versus 61.9 without; using quality-adjusted life years as an outcome, 75.9 versus 64.7 without; and cost-utility versus cost-minimization analysis, 75.9 versus 58.7. Studies most often satisfied quality aspects about stating study design choices and least often satisfied aspects about justifying design choices. The reviewed literature considered a minority of the 2008-2009 novel drugs and had mixed study quality. Cost-effectiveness stakeholders might benefit from efforts to improve the quality and quantity of literature examining novel drugs. Editors and reviewers may support quality improvement by stringently imposing economic evaluation guidelines about justifying study design choices. © The Author(s) 2016.

  11. Turnover among nursing home staff. A review.

    PubMed

    Cohen-Mansfield, J

    1997-05-01

    Turnover is especially critical in nursing homes: continuity of care and personal relationships between care-givers and residents are important determinants of quality of care. Additionally, for the cognitively impaired nursing home resident, constant change of staff is bound to aggravate disorientation. Research demonstrates links between turnover and employment/employee characteristics and employment availability.

  12. The impact of staff training on staff outcomes in dementia care: a systematic review.

    PubMed

    Spector, Aimee; Revolta, Catherine; Orrell, Martin

    2016-11-01

    Caring for people with dementia can be emotionally challenging and is often linked to low job satisfaction and burnout in care staff. Staff training within care settings is potentially valuable in improving well-being and quality of care. This review aimed to (i) establish the impact of training on staff outcomes; (ii) compare the impact of different training approaches; (iii) explore the influence of training intensity; and (iv) explore potential barriers to success. A database search of staff training interventions revealed 207 papers, 188 of which were excluded based on prespecified criteria. Nineteen studies were included and appraised using a quality rating tool. Overall, the studies were found to be of variable quality; however, 16 studies found a significant change following training in at least one staff domain, with knowledge improving most frequently. Approaches focusing on managing challenging behaviours appeared to be the most effective. Training staff can be an effective method of improving well-being, and programmes helping staff to manage challenging behaviour appear to be the most beneficial. There is no clear relationship between training intensity and outcome. Most studies point to the importance of addressing organisational factors as a barrier to change. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  13. Program Review: Staff and Organizational Development, 1989-90.

    ERIC Educational Resources Information Center

    College of Marin, Kentfield, CA.

    College of Marin (California) is in the process of developing program review models for all of its programs and services. This report presents the results of the first-time implementation of the program review model development for the college's Staff and Organizational Development Program. Covering 1989-90 activities, the report reviews the…

  14. FDA Accelerates Testing and Review of Experimental Brain Cancer Drug | FNLCR Staging

    Cancer.gov

    An investigational brain cancer drug made with disabled polio virus and manufactured at the Frederick National Lab has won breakthrough status from the Food and Drug Administration (FDA) to fast-track its further refinement and clinical testing.  Br

  15. FDA Accelerates Testing and Review of Experimental Brain Cancer Drug | FNLCR

    Cancer.gov

    An investigational brain cancer drug made with disabled polio virus and manufactured at the Frederick National Lab has won breakthrough status from the Food and Drug Administration (FDA) to fast-track its further refinement and clinical testing.  Br

  16. The complications of controlling agency time discretion: FDA review deadlines and postmarket drug safety.

    PubMed

    Carpenter, Daniel; Chattopadhyay, Jacqueline; Moffitt, Susan; Nall, Clayton

    2012-01-01

    Public agencies have discretion on the time domain, and politicians deploy numerous policy instruments to constrain it. Yet little is known about how administrative procedures that affect timing also affect the quality of agency decisions. We examine whether administrative deadlines shape decision timing and the observed quality of decisions. Using a unique and rich dataset of FDA drug approvals that allows us to examine decision timing and quality, we find that this administrative tool induces a piling of decisions before deadlines, and that these “just-before-deadline” approvals are linked with higher rates of postmarket safety problems (market withdrawals, severe safety warnings, safety alerts). Examination of data from FDA advisory committees suggests that the deadlines may impede quality by impairing late-stage deliberation and agency risk communication. Our results both support and challenge reigning theories about administrative procedures, suggesting they embody expected control-expertise trade-offs, but may also create unanticipated constituency losses.

  17. Drugs@FDA: FDA Approved Drug Products

    MedlinePlus

    ... Cosmetics Tobacco Products Home Drug Databases Drugs@FDA Drugs@FDA: FDA Approved Drug Products Share Tweet Linkedin Pin it More sharing options Linkedin Pin it Email Print Search by Drug Name, Active Ingredient, or Application Number Enter at ...

  18. Staff Development in Higher Education: An International Review and Bibliography.

    ERIC Educational Resources Information Center

    Teather, David C. B., Ed.

    A review and bibliography of staff development in higher education in several countries is presented. Contents are as follows: Australia by Geoff Foster and Ernest Roe; Britain universities by John Nisbet and Ray McAleese; Britain polytechnics by Harriet Greenaway and Derek Mortimer; Canada by Bruce M. Shore; Denmark by John Conrad; The Federal…

  19. A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA from 2007-2013

    PubMed Central

    Egger, Gunter F.; Wharton, Gerold T.; Malli, Suzanne; Temeck, Jean; Murphy, M. Dianne; Tomasi, Paolo

    2016-01-01

    Background The European Union and the United States have different legal frameworks in place for pediatric drug development, which can potentially lead to different pediatric research requirements for the pharmaceutical industry. This manuscript compares pediatric clinical trial waivers granted by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Methods This is a retrospective review comparing EMA’s Paediatric Committee (PDCO) decisions with FDA’s Pediatric Review Committee (PeRC) recommendations for all product-specific pediatric full waiver applications submitted to EMA from January 2007 through December 2013. Using baseline data from EMA, we matched product-specific waivers with their FDA equivalents during the study period. Results For single active substance products, PDCO and PeRC adopted similar opinions in 42 of 49 indications (86%). For fixed-dose combinations, PDCO and PeRC adopted similar opinions in 24 of 31 indications (77%). Conclusion Despite the different legal frameworks, criteria, and processes of determination, the waiver decisions of the 2 agencies were similar in the majority of cases. PMID:27274951

  20. The draft FDA guideline on non-inferiority clinical trials: a critical review from European pharmaceutical industry statisticians.

    PubMed

    Huitfeldt, Bernhard; Hummel, Jürgen

    2011-01-01

    The European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) engages more than 2000 statisticians through its ten national organizations. Amongst other things, EFSPI is involved in reviewing regulatory guidelines under development, including the draft FDA guideline on non-inferiority clinical trials. This review resulted in several critical comments relating to as follows: (i) the lack of one single standard for proving efficacy of new drugs implied by the guideline; (ii) the problems with the suggested 'fraction of effect to be preserved'; (iii) the formulation of the primary hypothesis in a non-inferiority trial aiming at indirectly demonstrating a new drug is superior to placebo; and (iv) the preference in the guideline for the fixed-margin method over the synthesis method in the analysis. The presumed implications of this guideline, if implemented as is, are (i) increased confusion of how efficacy could be demonstrated when placebo control is not available, (ii) more complicated communication between pharmaceutical industry and FDA because of the apparent disagreements on fundamental statistical matters, and (iii) illogical consequences in the approval process because of which order drugs are approved rather than how they fulfill the regulatory requirements. We believe that the area is not yet ready for such a prescriptive regulatory guidance and that further research and experience are required until the methodology can be finally agreed. A strategy needs to be developed by regulatory agencies together with drug industry and academia for a long term solution for this topic.

  1. Drug disposition and drug-drug interaction data in 2013 FDA new drug applications: a systematic review.

    PubMed

    Yu, Jingjing; Ritchie, Tasha K; Mulgaonkar, Aditi; Ragueneau-Majlessi, Isabelle

    2014-12-01

    The aim of the present work was to perform a systematic review of drug metabolism, transport, pharmacokinetics, and DDI data available in the NDAs approved by the FDA in 2013, using the University of Washington Drug Interaction Database, and to highlight significant findings. Among 27 NMEs approved, 22 (81%) were well characterized with regard to drug metabolism, transport, or organ impairment, in accordance with the FDA drug interaction guidance (2012) and were fully analyzed in this review. In vitro, a majority of the NMEs were found to be substrates or inhibitors/inducers of at least one drug metabolizing enzyme or transporter. However, in vivo, only half (n = 11) showed clinically relevant drug interactions, with most related to the NMEs as victim drugs and CYP3A being the most affected enzyme. As perpetrators, the overall effects for NMEs were much less pronounced, compared with when they served as victims. In addition, the pharmacokinetic evaluation in patients with hepatic or renal impairment provided useful information for further understanding of the drugs' disposition.

  2. 76 FR 35949 - Agency Information Collection Activity (Servicer's Staff Appraisal Reviewer (SAR) Application...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-20

    ... Collection Activity (Servicer's Staff Appraisal Reviewer (SAR) Application) Under OMB Review AGENCY: Veterans...: Servicer's Staff Appraisal Reviewer (SAR) Application, VA Form 26-0829. OMB Control Number: 2900-0715. Type... servicers to nominate employees for approval as Staff Appraisal Reviewer (SAR). Servicers SAR's will...

  3. Review of embryo-fetal developmental toxicity studies performed for recent FDA-approved pharmaceuticals.

    PubMed

    Ishihara-Hattori, Kana; Barrow, Paul

    2016-09-01

    Details of embryo-fetal development (EFD) studies were compiled from published FDA approval documents for 43 small molecule drugs (2014-2015) and 37 monoclonal antibodies (mAbs, 2002-2015). Anti-cancer agents were analyzed separately. Rats and rabbits were the species used for EFD studies on 93% of small molecule drugs. Overall, the rat and rabbit were equally sensitive to maternal and fetal toxicity (including teratogenicity). Dosages equivalent to more than 50-times the human exposure (or 10-times for mAbs) were frequently used, but were unnecessary for 90% of drugs. EFD studies were not required for several recently approved mAbs owing to pre-existing scientific knowledge. The cynomolgus monkey was used for developmental toxicity testing of 75% of mAbs, frequently using an ePPND study design. Studies in pregnant rodents using homologous murine antibodies supplemented or replaced monkey studies under some circumstances. Most anti-cancer small molecules and mAbs were tested for developmental toxicity in at least one species. Copyright © 2016 Elsevier Inc. All rights reserved.

  4. Safety and Procedural Success of Left Atrial Appendage Exclusion With the Lariat Device: A Systematic Review of Published Reports and Analytic Review of the FDA MAUDE Database.

    PubMed

    Chatterjee, Saurav; Herrmann, Howard C; Wilensky, Robert L; Hirshfeld, John; McCormick, Daniel; Frankel, David S; Yeh, Robert W; Armstrong, Ehrin J; Kumbhani, Dharam J; Giri, Jay

    2015-07-01

    The Lariat device has received US Food and Drug Administration (FDA) 510(k) clearance for soft-tissue approximation and is being widely used off-label for left atrial appendage (LAA) exclusion. A comprehensive analysis of safety and effectiveness has not been reported. To perform a systematic review of published literature to assess safety and procedural success, defined as successful closure of the LAA during the index procedure, of the Lariat device. We performed a formal analytic review of the FDA MAUDE (Manufacturer and User Facility Device Experience) database to compile adverse event reports from real-world practice with the Lariat. For the systematic review, PubMed, EMBASE, CINAHL, and the Cochrane Library were searched from January 2007 through August 2014 to identify all studies reporting use of the Lariat device in 3 or more patients. The FDA MAUDE database was queried for adverse events reports related to Lariat use. Data were abstracted in duplicate by 2 physician reviewers. Events from published literature were pooled using a generic inverse variance weighting with a random effects model. Cumulative and individual adverse events were also reported using the FDA MAUDE data set. Procedural adverse events and procedural success. In the systematic review, 5 reports of Lariat device use in 309 participants were identified. Specific complications weighted for inverse of variance of individual studies were urgent need for cardiac surgery (2.3%; 7 of 309 procedures) and death (0.3%; 1 of 309 procedures). Procedural success was 90.3% (279 of 309 procedures). In the FDA MAUDE database, there were 35 unique reports of adverse events with use of the Lariat device. Among these, we identified 5 adverse event reports that noted pericardial effusion and death and an additional 23 reported urgent cardiac surgery without mention of death. This review of published reports and case reports identified risks of adverse events with off-label use of the Lariat device for LAA

  5. Bridge-Enhanced ACL Repair: A Review of the Science and the Pathway through FDA Investigational Device Approval

    PubMed Central

    Proffen, Benedikt L.; Perrone, Gabriel S.; Roberts, Gordon; Murray, Martha M.

    2016-01-01

    Injuries to the anterior cruciate ligament (ACL) are currently treated with replacement of the torn ligament with a graft of tendon harvested from elsewhere in the knee. This procedure, called "ACL reconstruction," is excellent for restoring gross stability to the knee; however, there are relatively high graft failure rates in adolescent patients,4, 12, 60 and the ACL reconstruction procedure does not prevent the premature osteoarthritis seen in patients after an ACL injury.1, 46, 52 Thus, new solutions are needed for ACL injuries. Researchers have been investigating the use of scaffolds, growth factors and cells to supplement a suture repair of the ACL (bio-enhanced repair). In this paper, we will review the varied approaches, which have been investigated for stimulating ACL healing and repair in preclinical models and how one of these technologies was able to move from promising preclinical results to FDA acceptance of an Investigational Device Exemption (IDE) application for a first-in-human study. PMID:25631206

  6. FDA-Approved HIV Medicines

    MedlinePlus

    HIV Treatment FDA-Approved HIV Medicines (Last updated 2/27/2017; last reviewed 2/27/2017) Treatment with ... 2007 Pharmacokinetic Enhancers Pharmacokinetic enhancers are used in HIV treatment to increase the effectiveness of an HIV medicine ...

  7. Managing delegation in the FDA: reducing delay in new-drug review.

    PubMed

    Olson, Mary K

    2004-06-01

    This article examines the effects of the user fee reform on the speed of drug review in the U.S. Food and Drug Administration. The results show that even after controlling for increased agency resources, the reform reduced review times among new-drug approvals by 34 percent (95 percent confidence interval, 11 to 51 percent, p = .01). The results suggest that increased agency resources alone cannot explain the reductions in drug-review times. Evidence suggests that other reform-specific factors facilitated the change. Such factors may include the agency's desire to obtain program renewal and secure future fee revenues as well as heightened industry monitoring. Additional results show that there were significant increases in the speed of review for novel drugs in the reform era and for drugs in certain classes that have historically experienced longer delays. The results suggest that the user fee reform has helped politicians manage delegation and reduce delay in new-drug review.

  8. FDA labeling of NSAIDs: Review of nonsteroidal anti-inflammatory drugs in cardiovascular disease.

    PubMed

    Pirlamarla, Preethi; Bond, Rachel M

    2016-11-01

    Nonsteroidal anti-inflammatory drugs (NSAIDs) have been extensively used worldwide for both chronic and acute musculoskeletal and inflammatory conditions. Extensive evidence has linked NSAID use with adverse cardiovascular events. This review article aims to review the existing evidence on the risk of cardiovascular and coronary events in both selective and nonselective NSAIDs, the time course of NSAIDs associated with cardiovascular risk, and specific populations that may be at increased risk. Copyright © 2016 Elsevier Inc. All rights reserved.

  9. Computer validation in toxicology: historical review for FDA and EPA good laboratory practice.

    PubMed

    Brodish, D L

    1998-01-01

    The application of computer validation principles to Good Laboratory Practice is a fairly recent phenomenon. As automated data collection systems have become more common in toxicology facilities, the U.S. Food and Drug Administration and the U.S. Environmental Protection Agency have begun to focus inspections in this area. This historical review documents the development of regulatory guidance on computer validation in toxicology over the past several decades. An overview of the components of a computer life cycle is presented, including the development of systems descriptions, validation plans, validation testing, system maintenance, SOPs, change control, security considerations, and system retirement. Examples are provided for implementation of computer validation principles on laboratory computer systems in a toxicology facility.

  10. Inadvertent Stent Retriever Detachment: A Multicenter Case Series and Review of Device Experience FDA Reports.

    PubMed

    Masoud, Hesham; Nguyen, Thanh N; Martin, Coleman O; Holloway, William E; Ambekar, Sudheer; Yavagal, Dileep R; Haussen, Diogo C; Nogueira, Raul; Lozano, Diego J; Puri, Ajit; Quateen, Ayman; Iancu, Daniela; Abraham, Michael G; Chen, Michael; Mehta, Sonal; Malisch, Tim; Marden, Franklin; Novakovic, Robin; Roy, Daniel; Weill, Alain; Norbash, Alexander M

    2016-03-01

    Mechanical thrombectomy using retrievable stents or stent retriever devices has become the mainstay of intra-arterial therapy for acute ischemic stroke. The recent publication of a series of positive trials supporting intra-arterial therapy as standard of care for the treatment of large vessel occlusion will likely further increase stent retriever use. Rarely, premature stent detachment during thrombectomy may be encountered. In our multicenter case series, we found a rate of detachment of less than 1% (n = 7/1,067), and all were first-generation Solitaire FR devices. A review of the US Food and Drug Administration database of device experience yielded 90 individual adverse reports of detachment. There were 82, 1 and 7 detachments of Solitaire FR (first generation), Solitaire FR2 (second generation) and Trevo devices, respectively. We conclude with a brief overview of the technical and procedural considerations which may be helpful in avoiding this rare complication.

  11. Device failures associated with patient injuries during robot-assisted laparoscopic surgeries: a comprehensive review of FDA MAUDE database.

    PubMed

    Andonian, Sero; Okeke, Zeph; Okeke, Deidre A; Rastinehad, Ardeshir; Vanderbrink, Brian A; Richstone, Lee; Lee, Benjamin R

    2008-02-01

    Robot-assisted laparoscopic surgery has increased in the areas of cardiac and urologic surgery. We sought to determine the number of reported device malfunctions leading to patient injuries. We performed a review of the MAUDE database of the FDA. Adverse events (AE) were defined as potential and actual product use errors and product quality problems. All incidents involving the ZEUS and da Vinci surgical robots were analyzed. The MAUDE database was last accessed on August 27, 2007. A total of 189 AEs were reported from 2000 to August 27, 2007. Assuming that 50,000 robotic-assisted laparoscopic cases have been performed, this represents 0.38% overall estimated failure rate. Twenty-one malfunctions were reported for the ZEUS robotic system between 2001 and 2003, while 168 malfunctions were reported for the da Vinci robotic system between 2000 and 2007. The rate of open conversions due to device malfunction decreased from 94% in 2003 to 16% in 2007. Of the 189 reported device malfunctions, only 9 (4.8%) were associated with patient injury. The increasing use of robotic-assisted surgery has led to an increase in the number of reported device malfunctions, albeit at a very small estimated rate of 0.38%. With experience, the rate of open conversions due to device malfunction decreased. Only a small percentage of these adverse occurrences were associated with patient injury.

  12. Systematic Review: FDA-Approved Prescription Medications for Adults With Constipation

    PubMed Central

    Lacy, Brian E.

    2006-01-01

    Constipation is a common, often chronic, gastrointestinal disorder that can negatively impact the lives of those it affects and can be difficult to treat satisfactorily. The objective of this systematic review is to identify and analyze the available published literature on US Food and Drug Administration–approved prescription therapies for adults with constipation (episodic and chronic) and to assess their place in therapy, based on the methodologic strength and results of identified clinical trials. Ovid MEDLINE, PubMed, and EMBASE databases were used to search the published literature. Studies were included if they were randomized and prospective, conducted in adults (age ≥18), published as full-length manuscripts in English, and compared the test agent with placebo or a comparator(s). Studies were excluded if they involved patients with constipation attributed to secondary causes. Because fully published manuscripts from phase III efficacy trials involving the recently approved medication lubiprostone were not available, a manual search was performed of abstracts from the two annual major gastroenterology meetings (American College of Gastroenterology and Digestive Disease Week) from the past 4 years. Data on study design; number, age, and sex of patients; duration of treatment period; primary efficacy variable; secondary efficacy variables; adverse events; and discontinuations because of adverse events were abstracted from eligible articles. Eligible studies were assessed using well-established recommendations and a preformatted standardized form. A scoring system, with scores ranging from 1 to 15, was used to individually and separately assess the methodologic quality of the studies. Results of this analysis indicate a general lack of methodologically high-quality clinical trials supporting the use of lactulose and PEG 3350 to treat patients with chronic constipation, but data support their use in acute, episodic constipation. Conversely, high

  13. 77 FR 14404 - Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... HUMAN SERVICES Food and Drug Administration Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for...

  14. Staff nurses' experiences as preceptors and mentors: an integrative review.

    PubMed

    Omansky, Gayle L

    2010-09-01

    The aim of this integrative review is to describe staff nurses' experience when functioning as a preceptor or mentor for student nurses. The preceptor's role is to guide students from the theory of nursing to the application of nursing theory, teaching clinical skills and clinical thinking. Relatively few research studies focus on the staff nurses' experience. Research studies and topical articles from Australia, Canada, Sweden, the United Kingdom and the United States were drawn from databases. The theoretical framework for the analysis was the Kahn et al. (1964) role episode model. Reservations over the efficacy of preceptor experiences have been identified. Along with intrinsic rewards, there is considerable stress and responsibility associated with precepting or mentoring. Nurse preceptors experience role ambiguity, conflict and overload when interacting with students. Research indicates what might reduce the amount of stress for the nurse preceptor and increase job satisfaction and nurse retention. Defining and formalising the preceptor role can improve the standing of this function. Adjustments can be made to decrease the stress of the role. Preceptors and mentors request recognition and support for the amount of work involved in teaching students. © 2010 The Author. Journal compilation © 2010 Blackwell Publishing Ltd.

  15. Patient Reported Outcome (PRO) assessment in epilepsy: a review of epilepsy-specific PROs according to the Food and Drug Administration (FDA) regulatory requirements

    PubMed Central

    2013-01-01

    Despite collection of patient reported outcome (PRO) data in clinical trials of antiepileptic drugs (AEDs), PRO results are not being routinely reported on European Medicines Agency (EMA) and Food and Drug Administration (FDA) product labels. This review aimed to evaluate epilepsy-specific PRO instruments against FDA regulatory standards for supporting label claims. Structured literature searches were conducted in Embase and Medline databases to identify epilepsy-specific PRO instruments. Only instruments that could potentially be impacted by pharmacological treatment, were completed by adults and had evidence of some validation work were selected for review. A total of 26 PROs were reviewed based on criteria developed from the FDA regulatory standards. The ability to meet these criteria was classified as either full, partial or no evidence, whereby partial reflected some evidence but not enough to comprehensively address the FDA regulatory standards. Most instruments provided partial evidence of content validity. Input from clinicians and literature was common although few involved patients in both item generation and cognitive debriefing. Construct validity was predominantly compromised by no evidence of a-priori hypotheses of expected relationships. Evidence for test-retest reliability and internal consistency was available for most PROs although few included complete results regarding all subscales and some failed to reach recommended thresholds. The ability to detect change and interpretation of change were not investigated in most instruments and no PROs had published evidence of a conceptual framework. The study concludes that none of the 26 have the full evidence required by the FDA to support a label claim, and all require further research to support their use as an endpoint. The Subjective Handicap of Epilepsy (SHE) and the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) have the fewest gaps that would need to be addressed through

  16. Patient Reported Outcome (PRO) assessment in epilepsy: a review of epilepsy-specific PROs according to the Food and Drug Administration (FDA) regulatory requirements.

    PubMed

    Nixon, Annabel; Kerr, Cicely; Breheny, Katie; Wild, Diane

    2013-03-11

    Despite collection of patient reported outcome (PRO) data in clinical trials of antiepileptic drugs (AEDs), PRO results are not being routinely reported on European Medicines Agency (EMA) and Food and Drug Administration (FDA) product labels. This review aimed to evaluate epilepsy-specific PRO instruments against FDA regulatory standards for supporting label claims. Structured literature searches were conducted in Embase and Medline databases to identify epilepsy-specific PRO instruments. Only instruments that could potentially be impacted by pharmacological treatment, were completed by adults and had evidence of some validation work were selected for review. A total of 26 PROs were reviewed based on criteria developed from the FDA regulatory standards. The ability to meet these criteria was classified as either full, partial or no evidence, whereby partial reflected some evidence but not enough to comprehensively address the FDA regulatory standards. Most instruments provided partial evidence of content validity. Input from clinicians and literature was common although few involved patients in both item generation and cognitive debriefing. Construct validity was predominantly compromised by no evidence of a-priori hypotheses of expected relationships. Evidence for test-retest reliability and internal consistency was available for most PROs although few included complete results regarding all subscales and some failed to reach recommended thresholds. The ability to detect change and interpretation of change were not investigated in most instruments and no PROs had published evidence of a conceptual framework. The study concludes that none of the 26 have the full evidence required by the FDA to support a label claim, and all require further research to support their use as an endpoint. The Subjective Handicap of Epilepsy (SHE) and the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) have the fewest gaps that would need to be addressed through

  17. Review article: Staff perception of the emergency department working environment: Integrative review of the literature.

    PubMed

    Johnston, Amy; Abraham, Louisa; Greenslade, Jaimi; Thom, Ogilvie; Carlstrom, Eric; Wallis, Marianne; Crilly, Julia

    2016-02-01

    Employees in EDs report increasing role overload because of critical staff shortages, budgetary cuts and increased patient numbers and acuity. Such overload could compromise staff satisfaction with their working environment. This integrative review identifies, synthesises and evaluates current research around staff perceptions of the working conditions in EDs. A systematic search of relevant databases, using MeSH descriptors ED/EDs, Emergency room/s, ER/s, or A&E coupled with (and) working environment, working condition/s, staff perception/s, as well as reference chaining was conducted. We identified 31 key studies that were evaluated using the mixed methods assessment tool (MMAT). These comprised 24 quantitative-descriptive studies, four mixed descriptive/comparative (non-randomised controlled trial) studies and three qualitative studies. Studies included varied widely in quality with MMAT scores ranging from 0% to 100%. A key finding was that perceptions of working environment varied across clinical staff and study location, but that high levels of autonomy and teamwork offset stress around high pressure and high volume workloads. The large range of tools used to assess staff perception of working environment limits the comparability of the studies. A dearth of intervention studies around enhancing working environments in EDs limits the capacity to recommend evidence-based interventions to improve staff morale. © 2016 The Authors. Emergency Medicine Australasia published by John Wiley & Sons Australia, Ltd on behalf of Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

  18. Review article: Staff perception of the emergency department working environment: Integrative review of the literature

    PubMed Central

    Abraham, Louisa; Greenslade, Jaimi; Thom, Ogilvie; Carlstrom, Eric; Wallis, Marianne; Crilly, Julia

    2016-01-01

    Abstract Employees in EDs report increasing role overload because of critical staff shortages, budgetary cuts and increased patient numbers and acuity. Such overload could compromise staff satisfaction with their working environment. This integrative review identifies, synthesises and evaluates current research around staff perceptions of the working conditions in EDs. A systematic search of relevant databases, using MeSH descriptors ED/EDs, Emergency room/s, ER/s, or A&E coupled with (and) working environment, working condition/s, staff perception/s, as well as reference chaining was conducted. We identified 31 key studies that were evaluated using the mixed methods assessment tool (MMAT). These comprised 24 quantitative‐descriptive studies, four mixed descriptive/comparative (non‐randomised controlled trial) studies and three qualitative studies. Studies included varied widely in quality with MMAT scores ranging from 0% to 100%. A key finding was that perceptions of working environment varied across clinical staff and study location, but that high levels of autonomy and teamwork offset stress around high pressure and high volume workloads. The large range of tools used to assess staff perception of working environment limits the comparability of the studies. A dearth of intervention studies around enhancing working environments in EDs limits the capacity to recommend evidence‐based interventions to improve staff morale. © 2016 The Authors. Emergency Medicine Australasia published by John Wiley & Sons Australia, Ltd on behalf of Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine PMID:26784282

  19. 21 CFR 60.34 - FDA action on petitions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA action on petitions. 60.34 Section 60.34 Food... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... during the regulatory review period. FDA will publish its due diligence determination in the...

  20. A review of NRC staff uses of probabilistic risk assessment

    SciTech Connect

    Not Available

    1994-03-01

    The NRC staff uses probabilistic risk assessment (PRA) and risk management as important elements its licensing and regulatory processes. In October 1991, the NRC`s Executive Director for Operations established the PRA Working Group to address concerns identified by the Advisory Committee on Reactor Safeguards with respect to unevenness and inconsistency in the staff`s current uses of PRA. After surveying current staff uses of PRA and identifying needed improvements, the Working Group defined a set of basic principles for staff PRA use and identified three areas for improvements: guidance development, training enhancements, and PRA methods development. For each area of improvement, the Working Group took certain actions and recommended additional work. The Working Group recommended integrating its work with other recent PRA-related activities the staff completed and improving staff interactions with PRA users in the nuclear industry. The Working Group took two key actions by developing general guidance for two uses of PRA within the NRC (that is, screening or prioritizing reactor safety issues and analyzing such issues in detail) and developing guidance on basic terms and methods important to the staff`s uses of PRA.

  1. Drugs@FDA: FDA Approved Drug Products

    MedlinePlus

    ... by Month Approvals, tentative approvals, and supplements Original New Drug Approvals (NDAs and BLAs) by Month All applications ... FDA. Does not include tentative approvals. Original Abbreviated New Drug Approvals (ANDAs) by Month Generic Drug Approvals. Does ...

  2. FDA pharmaceutical quality oversight.

    PubMed

    Yu, Lawrence X; Woodcock, Janet

    2015-08-01

    The launch of the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) is a milestone in FDA's efforts to assure that quality medicines are available to the American public. As a new super-office within CDER, OPQ is strategically organized to streamline regulatory processes, advance regulatory standards, align areas of expertise, and originate surveillance of drug quality. Supporting these objectives will be an innovative and systematic approach to product quality knowledge management and informatics. Concerted strategies will bring parity to the oversight of innovator and generic drugs as well as domestic and international facilities. OPQ will promote and encourage the adoption of emerging pharmaceutical technology to enhance pharmaceutical quality and potentially reinvigorate the pharmaceutical manufacturing sector in the United States. With a motto of "One Quality Voice," OPQ embodies the closer integration of review, inspection, surveillance, policy, and research for the purpose of strengthening pharmaceutical quality on a global scale.

  3. Transformational leadership and staff retention: an evidence review with implications for healthcare systems.

    PubMed

    Weberg, Dan

    2010-01-01

    A significant amount of burnout and attrition of nurses occurs in healthcare systems. Nursing leadership has a significant impact on these factors. The purpose of this article is to present an evidence review to determine the impact of transformational leadership on staff satisfaction and burnout. It was found that transformational leadership is significantly related to increased satisfaction, increased staff well-being, decreased burnout, and decreased overall stress in staff nurses.

  4. Attitudes and beliefs of staff to feedback following the review of adverse events in clinical care.

    PubMed

    Kelleher, Sharyn; Buckley, David; Reyment, Jill

    2013-09-01

    To undertake a pilot project to determine how clinical and non-clinical staff perceive feedback given to them following clinical incident reviews. An online survey was devised and sent as a link to staff across the Murrumbidgee Local Health District who would be likely to submit patient-related adverse incidents into the NSW Health Incident Information Management System. Two hundred and twenty-eight responses were received. Feedback was viewed as constructive and helpful. Medical staff were less enthusiastic about feedback and preferred formal feedback processes. Feedback from clinical incident reviews closes the loop of the review process and creates a platform for necessary changes to be undertaken.

  5. Planning for effective interaction with FDA.

    PubMed

    Spurgin, Elizabeth A

    2004-12-01

    Manufacturers of diabetes devices can facilitate the formal regulatory approval process through early interaction with the U.S. Food and Drug Administration (FDA). Effective planning can help manage commonly perceived risks of interaction with the Agency, introduce new technologies to regulatory reviewers, and inform the manufacturer's product development strategy. This article reviews key aspects of the FDA evaluation process and suggests strategies that may facilitate effective communication with the Agency. Integrating early communication with FDA into broader product commercialization planning can streamline regulatory review and lead to early product launch into reimbursed markets.

  6. Cervical artificial disc replacement versus fusion in the cervical spine: a systematic review comparing long-term follow-up results from two FDA trials

    PubMed Central

    Mummaneni, Praveen V.; Amin, Beejal Y.; Wu, Jau-Ching; Brodt, Erika D.; Dettori, Joseph R.; Sasso, Rick C.

    2012-01-01

    Study design: Systematic review. Clinical question: Does single-level unconstrained, semiconstrained, or fully constrained cervical artificial disc replacement (C-ADR) improve health outcomes compared with single-level anterior cervical discectomy and fusion (ACDF) in the long-term? Methods: A systematic review was undertaken for articles published up to October 2011. Electronic databases and reference lists of key articles were searched to identify US Food and Drug Administration (FDA) studies reporting long-term (≥ 48 months) follow-up results of C-ADR compared with ACDF. Non-FDA trials and FDA trials reporting outcomes at short-term or mid-term follow-up periods were excluded. Two independent reviewers assessed the strength of evidence using the GRADE criteria and disagreements were resolved by consensus. Results: Two FDA trials reporting outcomes following C-ADR (Bryan disc, Prestige disc) versus ACDF at follow-up periods of 48 months and 60 months were found (follow-up rates are 68.7% [318/463] and 50.1% [271/541], respectively). Patients in the C-ADR group showed a higher rate of overall success, greater improvements in Neck Disability Index, neck and arm pain scores, and SF-36 PhysicalComponent Scores at long-term follow-up compared with those in the ACDF group. The rate of adjacent segment disease was less in the C-ADR group versus the ACDF group at 60 months (2.9% vs 4.9%). Normal segmental motion was maintained in the C-ADR group. Furthermore, rates of revision and supplemental fixation surgical procedures were lower in the arthroplasty group. Conclusions: C-ADR is a viable treatment option for cervical herniated disc/spondylosis with radiculopathy resulting in improved clinical outcomes, maintenance of normal segmental motion, and low rates of subsequent surgical procedures at 4 to 5 years follow-up. More studies with long-term follow-up are warranted. PMID:23236315

  7. Review of Medical School Administrative Staff Salaries, 1976-1977.

    ERIC Educational Resources Information Center

    Association of American Medical Colleges, Washington, DC.

    Results of the most recent Administrative Salary Survey of the Association of American Medical Colleges are analyzed. The data represent 94 U.S. medical schools, with the number of applicable staff positions ranging from two to 52 per institution. The positions considered included those in which at least 20 percent of the time was spent in…

  8. A Learning Opportunity for Staff: Simulating an IT Department Review

    ERIC Educational Resources Information Center

    Sipher, Justin; Spencer, Gene

    2007-01-01

    Skidmore College CTO Justin Sipher wanted to develop a staff professional development activity that would focus on the general issue of organizational effectiveness. He contacted Gene Spencer, whom he had met at the 2001 Frye Institute, for help. Sipher and Spencer agreed that the theme of organizational effectiveness could be explored in a…

  9. Burnout in University Teaching Staff: A Systematic Literature Review

    ERIC Educational Resources Information Center

    Watts, J.; Robertson, N.

    2011-01-01

    Background: Teacher stress potentially impairs personal and professional competence and compromises productivity. Aversive emotional experience has been most comprehensively encapsulated by the phenomenon of burnout, which is particularly prominent for staff in human service sectors. Burnout reactions have been characterised as tripartite: the…

  10. Burnout in University Teaching Staff: A Systematic Literature Review

    ERIC Educational Resources Information Center

    Watts, J.; Robertson, N.

    2011-01-01

    Background: Teacher stress potentially impairs personal and professional competence and compromises productivity. Aversive emotional experience has been most comprehensively encapsulated by the phenomenon of burnout, which is particularly prominent for staff in human service sectors. Burnout reactions have been characterised as tripartite: the…

  11. A Learning Opportunity for Staff: Simulating an IT Department Review

    ERIC Educational Resources Information Center

    Sipher, Justin; Spencer, Gene

    2007-01-01

    Skidmore College CTO Justin Sipher wanted to develop a staff professional development activity that would focus on the general issue of organizational effectiveness. He contacted Gene Spencer, whom he had met at the 2001 Frye Institute, for help. Sipher and Spencer agreed that the theme of organizational effectiveness could be explored in a…

  12. Review of Medical School Administrative Staff Salaries, 1976-1977.

    ERIC Educational Resources Information Center

    Association of American Medical Colleges, Washington, DC.

    Results of the most recent Administrative Salary Survey of the Association of American Medical Colleges are analyzed. The data represent 94 U.S. medical schools, with the number of applicable staff positions ranging from two to 52 per institution. The positions considered included those in which at least 20 percent of the time was spent in…

  13. Clinical Nurse Specialists Guide Staff Nurses to Promote Practice Accountability Through Peer Review.

    PubMed

    Semper, Julie; Halvorson, Betty; Hersh, Mary; Torres, Clare; Lillington, Linda

    2016-01-01

    The aim of the study was to describe the clinical nurse specialist role in developing and implementing a staff nurse education program to promote practice accountability using peer review principles. Peer review is essential for professional nursing practice demanding a significant culture change. Clinical nurse specialists in a Magnet-designated community hospital were charged with developing a staff nurse peer review education program. Peer review is a recognized mechanism of professional self-regulation to ensure delivery of quality care. The American Nurses Association strongly urges incorporating peer review in professional nursing practice models. Clinical nurse specialists play a critical role in educating staff nurses about practice accountability. Clinical nurse specialists developed an education program guided by the American Nurses Association's principles of peer review. A baseline needs assessment identified potential barriers and learning needs. Content incorporated tools and strategies to build communication skills, collaboration, practice change, and peer accountability. The education program resulted in increased staff nurse knowledge about peer review and application of peer review principles in practice. Clinical nurse specialists played a critical role in helping staff nurses understand peer review and its application to practice. The clinical nurse specialist role will continue to be important in sustaining the application of peer review principles in practice.

  14. 76 FR 17649 - Science Advisory Board Staff Office; Request for Nominations; SAB Mercury Review Panel

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-30

    ... AGENCY Science Advisory Board Staff Office; Request for Nominations; SAB Mercury Review Panel AGENCY... Office provides notice that the SAB will form a panel to conduct an independent review of EPA's Mercury...) panel to conduct ] an independent review of EPA's Mercury Technical Support Document. As described...

  15. 78 FR 13070 - Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-26

    ... investigators, industry, and FDA staff in interpreting and complying with the regulations governing financial..., Industry, and Food and Drug Administration Staff: Financial Disclosure by Clinical Investigators..., Industry, and FDA Staff: Financial Disclosure by Clinical Investigators.'' This guidance is intended to...

  16. The influence of staff training on challenging behaviour in individuals with intellectual disability: a review.

    PubMed

    Cox, Alison D; Dube, Charmayne; Temple, Beverley

    2015-03-01

    Many individuals with intellectual disability engage in challenging behaviour. This can significantly limit quality of life and also negatively impact caregivers (e.g., direct care staff, family caregivers and teachers). Fortunately, efficacious staff training may alleviate some negative side effects of client challenging behaviour. Currently, a systematic review of studies evaluating whether staff training influences client challenging behaviour has not been conducted. The purpose of this article was to identify emerging patterns, knowledge gaps and make recommendations for future research on this topic. The literature search resulted in a total of 19 studies that met our inclusion criteria. Articles were separated into four staff training categories. Studies varied across sample size, support staff involved in training, study design, training duration and data collection strategy. A small sample size (n = 19) and few replication studies, alongside several other procedural limitations prohibited the identification of a best practice training approach. © The Author(s) 2014.

  17. Staff views about psychosocial aspects of recovery in psychosis: A systematic review.

    PubMed

    Morera, Tirma; Pratt, Daniel; Bucci, Sandra

    2017-03-01

    Mental health services remain largely set up to improve patient outcomes through symptom alleviation, but patient views of recovery are broader than symptom remission. Clinicians influence the nature of treatment patients received, but their views about recovery remain poorly understood. The aim of this study was to systematically review the literature examining staff views about psychosocial aspects of recovery in psychosis. We systematically searched the PsycInfo, EMBASE, MEDLINE, and CINAHL databases. Of the 6,225 articles identified, 15 met inclusion criteria for review. The studies reviewed showed a relatively inconsistent picture. Although there was evidence of staff endorsing psychosocial views of recovery, the majority of studies suggested staff endorsed biomedical models of recovery in psychosis and emphasized the importance of pharmacological, over psychosocial, and interventions. The reviewed studies showed that biomedical views about recovery prevail among multidisciplinary mental health staff, despite recent advancements in patients' broader conceptualization of recovery. Clinical implications are discussed. The psychosocial model of recovery has become widely accepted and now underpins most international recovery policies. Despite a dearth in research, existing studies indicate that mental health staff subscribe to biomedical models of recovery in psychosis, with more emphasis on pharmacological, over psychosocial, and interventions. Robust research targeting staff views about recovery in psychosis is needed. © 2016 The British Psychological Society.

  18. FDA Certified Mammography Facilities

    MedlinePlus

    ... Products Radiation-Emitting Products Home Radiation-Emitting Products Mammography Quality Standards Act and Program Consumer Information (MQSA) ... it Email Print This list of FDA Certified Mammography Facilities is updated weekly. If you click on ...

  19. FDA Certified Mammography Facilities

    MedlinePlus

    ... Program Consumer Information (MQSA) Search for a Certified Facility Share Tweet Linkedin Pin it More sharing options ... Email Print This list of FDA Certified Mammography Facilities is updated weekly. If you click on Search ...

  20. Trauma-related mental health problems among national humanitarian staff: a systematic review of the literature.

    PubMed

    Strohmeier, Hannah; Scholte, Willem F

    2015-01-01

    Working in humanitarian crisis situations is dangerous. National humanitarian staff in particular face the risk of primary and secondary trauma exposure which can lead to mental health problems. Despite this, research on the mental health of national staff is scarce, and a systematic analysis of up-to-date findings has not been undertaken yet. This article reviews the available literature on trauma-related mental health problems among national humanitarian staff. It focuses on the prevalence of selected mental health problems in relation to reference groups; sex and/or gender as predictive factors of mental health problems; and the influence of organization types on mental health problems. Three databases were systematically searched for relevant studies published in the English language in peer-reviewed journals. Fourteen articles matched the inclusion criteria. Findings suggest that national staff experience mental health problems and the prevalence of posttraumatic stress disorder, depression, and anxiety among this occupation group is mostly similar to or higher than among reference groups. Research on both substance use disorder and suicidal behavior among national staff is particularly scarce. The relation between sex and/or gender and mental health problems among national staff appears to be complex, and organizational staff support seems to be an important determinant for mental health. All findings call for increased attention from the humanitarian community and further research on the topic.

  1. Trauma-related mental health problems among national humanitarian staff: a systematic review of the literature

    PubMed Central

    Strohmeier, Hannah; Scholte, Willem F.

    2015-01-01

    Background Working in humanitarian crisis situations is dangerous. National humanitarian staff in particular face the risk of primary and secondary trauma exposure which can lead to mental health problems. Despite this, research on the mental health of national staff is scarce, and a systematic analysis of up-to-date findings has not been undertaken yet. Objective This article reviews the available literature on trauma-related mental health problems among national humanitarian staff. It focuses on the prevalence of selected mental health problems in relation to reference groups; sex and/or gender as predictive factors of mental health problems; and the influence of organization types on mental health problems. Method Three databases were systematically searched for relevant studies published in the English language in peer-reviewed journals. Results Fourteen articles matched the inclusion criteria. Findings suggest that national staff experience mental health problems and the prevalence of posttraumatic stress disorder, depression, and anxiety among this occupation group is mostly similar to or higher than among reference groups. Research on both substance use disorder and suicidal behavior among national staff is particularly scarce. The relation between sex and/or gender and mental health problems among national staff appears to be complex, and organizational staff support seems to be an important determinant for mental health. Conclusion All findings call for increased attention from the humanitarian community and further research on the topic. PMID:26589256

  2. 75 FR 81268 - Science Advisory Board Staff Office; Notification of Two Public Quality Review Teleconferences of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-27

    ... AGENCY Science Advisory Board Staff Office; Notification of Two Public Quality Review Teleconferences of... chartered SAB to conduct quality reviews of three SAB draft reports. On January 19, 2011, the chartered SAB... Aquatic Life Benchmark for Conductivity in Central Appalachian Streams.'' On January 20, 2011 the SAB will...

  3. 76 FR 10896 - Science Advisory Board Staff Office; Request for Nominations; CASAC Mercury Review Panel

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-28

    ... AGENCY Science Advisory Board Staff Office; Request for Nominations; CASAC Mercury Review Panel AGENCY... Committee (CASAC) panel to conduct an independent review of EPA's Mercury Technical Support Document. DATES... is developing a draft risk assessment for mercury, entitled Technical Support Document:...

  4. Trust between nursing management and staff in critical care: a literature review.

    PubMed

    Mullarkey, Majella; Duffy, Anita; Timmins, Fiona

    2011-01-01

    This paper aims to provide a comprehensive review of the topic of trust between nurses and nurse managers in the context of critical care units. A comprehensive literature review exploring the concept of trust between nurse and nurse managers was undertaken. Search terms were used both singularly and in combination and 71 relevant citations were found. Abstracts were read and in total 20 peer reviewed articles were retained as a result of consistency with project aims. Trust emerged as an essential component in the nurse-patient relationship. However, trust among staff and management received little attention. Trust emerges as an important attribute of effective nurse managers. Nurse managers need to appreciate the importance of fostering a trustworthy relationship with subordinates. Engendering trust between management and staff empowers staff and has positive organizational outcomes. © 2011 The Authors. Nursing in Critical Care © 2011 British Association of Critical Care Nurses.

  5. Leadership practices and staff nurses' intent to stay: a systematic review.

    PubMed

    Cowden, Tracy; Cummings, Greta; Profetto-McGrath, Joanne

    2011-05-01

    The aim of the present study was to describe the findings of a systematic review of the literature that examined the relationship between managers' leadership practices and staff nurses' intent to stay in their current position. The nursing shortage demands that managers focus on the retention of staff nurses. Understanding the relationship between leadership practices and nurses' intent to stay is fundamental to retaining nurses in the workforce. Published English language articles on leadership practices and staff nurses' intent to stay were retrieved from computerized databases and a manual search. Data extraction and quality assessments were completed for the final 23 research articles. Relational leadership practices influence staff nurses' intentions to remain in their current position. This study supports a positive relationship between transformational leadership, supportive work environments and staff nurses' intentions to remain in their current positions. Incorporating relational leadership theory into management practices will influence nurse retention. Advancing current conceptual models will increase knowledge of intent to stay. Clarifying the distinction between the concepts intent to stay and intent to leave is needed to establish a clear theoretical foundation for further intent to stay research. Nurse managers and leaders who practice relational leadership and ensure quality workplace environments are more likely to retain their staff. The findings of the present study support the claim that leadership practices influence staff nurse retention and builds on intent to stay knowledge. © 2011 The Authors. Journal compilation © 2011 Blackwell Publishing Ltd.

  6. Effectiveness of hospital staff mass-casualty incident training methods: a systematic literature review.

    PubMed

    Hsu, Edbert B; Jenckes, Mollie W; Catlett, Christina L; Robinson, Karen A; Feuerstein, Carolyn; Cosgrove, Sara E; Green, Gary B; Bass, Eric B

    2004-01-01

    Recently, mass-casualty incident (MCI) preparedness and training has received increasing attention at the hospital level. To review the existing evidence on the effectiveness of disaster drills, technology-based interventions and tabletop exercises in training hospital staff to respond to an MCI. A systematic, evidence-based process was conducted incorporating expert panel input and a literature review with the key terms: "mass casualty", "disaster", "disaster planning", and "drill". Paired investigators reviewed citation abstracts to identify articles that included evaluation of disaster training for hospital staff. Data were abstracted from the studies (e.g., MCI type, training intervention, staff targeted, objectives, evaluation methods, and results). Study quality was reviewed using standardized criteria. Of 243 potentially relevant citations, 21 met the defined criteria. Studies varied in terms of targeted staff, learning objectives, outcomes, and evaluation methods. Most were characterized by significant limitations in design and evaluation methods. Seventeen addressed the effectiveness of disaster drills in training hospital staff in responding to an MCI, four addressed technology-based interventions, and none addressed tabletop exercises. The existing evidence suggests that hospital disaster drills are effective in allowing hospital employees to become familiar with disaster procedures, identify problems in different components of response (e.g., incident command, communications, triage, patient flow, materials and resources, and security) and provide the opportunity to apply lessons learned to disaster response. The strength of evidence on other training methods is insufficient to draw valid recommendations. Current evidence on the effectiveness of MCI training for hospital staff is limited. A number of studies suggest that disaster drills can be effective in training hospital staff. However, more attention should be directed to evaluating the

  7. Characteristics of International Staff Victims of Psychiatric Patient Assaults: Review of Published Findings, 2013-2017.

    PubMed

    Flannery, Raymond B; Wyshak, Grace; Flannery, Georgina J

    2017-09-25

    Psychiatric patient assaults on staff are a worldwide occupational hazard for health care staff that results in human suffering and dollar cost expense. International research through 2012 documented the frequency of these assaults and a continuing high risk for nursing personnel. This present paper reviewed the international published literature on staff victims of patient assaults during the next five year period of 2013-2017. The findings indicate that assaults on staff remain a serious worldwide issue as it has been since the 1990s, even with new policy initiatives in place meant to reduce such violence. Nursing personnel continued to be at greater risk. The findings by continents and an updated methodological inquiry are presented.

  8. 75 FR 69069 - Science Advisory Board Staff Office Notification of a Public Meeting of the SAB Lead Review Panel

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-10

    ... AGENCY Science Advisory Board Staff Office Notification of a Public Meeting of the SAB Lead Review Panel... (SAB) Staff Office announces a public meeting of the SAB Lead Review Panel to peer review two draft EPA documents entitled Approach for Developing Lead Dust Hazard Standards for Residences and Approach for...

  9. A review of radiation countermeasures focusing on injury-specific medicinals and regulatory approval status: part II. Countermeasures for limited indications, internalized radionuclides, emesis, late effects, and agents demonstrating efficacy in large animals with or without FDA IND status.

    PubMed

    Singh, Vijay K; Garcia, Melissa; Seed, Thomas M

    2017-09-01

    The threat of a radiological/nuclear event is a critical concern for all government agencies involved in national security and public health preparedness. Countermeasures that are safe, easily administered, and effective at diminishing or eliminating adverse health effects to individuals and the overall public health impact of radiation exposure are urgently needed. Radiation countermeasures included in this three-part series have been classified under various subheadings based specifically on their developmental stages for United States Food and Drug Administration (FDA) approval. We have included FDA-approved agents for acute radiation syndrome (ARS) in part I. This is part II in which we have reviewed FDA-approved agents for limited indications, internalized radionuclides, emesis, late effects, radiomitigators available in the strategic national stockpile (SNS), agents with FDA investigational new drug (IND) status, and those with NHP efficacy data without FDA IND. Agents discussed in part III are those agents that have been peer reviewed, published, and have demonstrated significant survival benefits in animal models of ARS. Agents investigated in in vitro models only or studied in animal models without peer-reviewed publications have not been included. The dearth of FDA-approved radiation countermeasures has prompted intensified research for a new generation of radiation countermeasures. A number of promising radiation countermeasures are currently moving forward with continued support and effort by both governmental agencies and by publicly and privately held pharmaceutical companies. There is a limited number of countermeasures which are progressing well following the Animal Rule and may get approved in the near future, thus serving to close the gap of this critically important, unmet radiobiomedical need.

  10. FDA Approval for Imiquimod

    Cancer.gov

    On July 15, 2004, the U.S. Food and Drug Administration (FDA) announced the approval of a new indication for Aldara® (imiquimod) topical cream for the treatment of superficial basal cell carcinoma (sBCC), a type of skin cancer.

  11. Final FDA inspection manual.

    PubMed

    Donawa, M

    2001-04-01

    For some time now, the only publicly available compliance programme guidance manual on medical device inspections and administrative and enforcement activities has been a draft document. On 7 February 2001, a final guidance document was issued. This article discusses this document and its importance to non-US medical device manufacturers preparing for FDA facility inspections.

  12. Fact Sheets on Review of National Ambient Air Quality Standards for Ozone Staff Papers

    EPA Pesticide Factsheets

    The second draft Staff Paper points to an expanded body of health effects evidence suggesting a wide range of adverse health effects associated with exposure to ambient ozone. This is part of the process for review of the NAAQS for ground-level ozone.

  13. The Impact on Staff of Working with Personality Disordered Offenders: A Systematic Review

    PubMed Central

    Freestone, Mark C.; Wilson, Kim; Jones, Rose; Mikton, Chris; Milsom, Sophia; Sonigra, Ketan; Taylor, Celia; Campbell, Colin

    2015-01-01

    Background Personality disordered offenders (PDOs) are generally considered difficult to manage and to have a negative impact on staff working with them. Aims This study aimed to provide an overview of studies examining the impact on staff of working with PDOs, identify impact areas associated with working with PDOs, identify gaps in existing research,and direct future research efforts. Methods The authors conducted a systematic review of the English-language literature from 1964–2014 across 20 databases in the medical and social sciences. Results 27 papers were included in the review. Studies identified negative impacts upon staff including: negative attitudes, burnout, stress, negative counter-transferential experiences; two studies found positive impacts of job excitement and satisfaction, and the evidence related to perceived risk of violence from PDOs was equivocal. Studies demonstrated considerable heterogeneity and meta-analysis was not possible. The overall level of identified evidence was low: 23 studies (85%) were descriptive only, and only one adequately powered cohort study was found. Conclusions The review identified a significant amount of descriptive literature, but only one cohort study and no trials or previous systematic reviews of literatures. Clinicians and managers working with PDOs should be aware of the potential impacts identified, but there is an urgent need for further research focusing on the robust evaluation of interventions to minimise harm to staff working with offenders who suffer from personality disorder. PMID:26305891

  14. The Impact on Staff of Working with Personality Disordered Offenders: A Systematic Review.

    PubMed

    Freestone, Mark C; Wilson, Kim; Jones, Rose; Mikton, Chris; Milsom, Sophia; Sonigra, Ketan; Taylor, Celia; Campbell, Colin

    2015-01-01

    Personality disordered offenders (PDOs) are generally considered difficult to manage and to have a negative impact on staff working with them. This study aimed to provide an overview of studies examining the impact on staff of working with PDOs, identify impact areas associated with working with PDOs, identify gaps in existing research,and direct future research efforts. The authors conducted a systematic review of the English-language literature from 1964-2014 across 20 databases in the medical and social sciences. 27 papers were included in the review. Studies identified negative impacts upon staff including: negative attitudes, burnout, stress, negative counter-transferential experiences; two studies found positive impacts of job excitement and satisfaction, and the evidence related to perceived risk of violence from PDOs was equivocal. Studies demonstrated considerable heterogeneity and meta-analysis was not possible. The overall level of identified evidence was low: 23 studies (85%) were descriptive only, and only one adequately powered cohort study was found. The review identified a significant amount of descriptive literature, but only one cohort study and no trials or previous systematic reviews of literatures. Clinicians and managers working with PDOs should be aware of the potential impacts identified, but there is an urgent need for further research focusing on the robust evaluation of interventions to minimise harm to staff working with offenders who suffer from personality disorder.

  15. Global robotic experience and the type of surgical system impact the types of robotic malfunctions and their clinical consequences: an FDA MAUDE review.

    PubMed

    Lucas, Steven M; Pattison, Erik A; Sundaram, Chandru P

    2012-04-01

    To assess annual rates of robotic system malfunctions and compare the da Vinci S(®) system (dVS) and da Vinci(®) surgical system (dV). To assess the types of malfunctions and associated outcomes for robotic cases and determine the extent to which experience and technological improvements impact these. This study is a retrospective review of the US Food and Drug Administration (FDA) MAUDE (Manufacturer and User Facility Device Experience) database, a publicly available, voluntary reporting system (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm). The database was searched using the two phrases 'da Vinci' and 'Intuitive Surgical' from 2003 to 2009. Malfunctions of the instruments, console, patient-side cart, camera and cannula were recorded. Data on intraoperative injuries, case delays and conversions were also collected. In all, 1914 reports were reviewed (991 dVS and 878 dV, 45 unclassified) with peak years for reports of 2008 for dVS (571) and 2007 for dV (211), P < 0.001. With respect to time, the proportion of console and patient-side cart malfunctions declined from 2007 onward compared with the proportions prior to 2007 (5.1% vs 9.4% and 6.6% vs 10.9%). Patient injury did not change with year of surgery (0.5-5.4% of malfunctions, P= 0.358), open conversions declined (21.3% of malfunctions before 2007 vs 9.9% from 2007 onward, P < 0.001) and patient deaths increased (0.0013% of cases before 2007 vs 0.0061% of cases from 2007 onward, P < 0.001). With regard to robotic system, console and patient-side cart malfunctions were more frequent with the dV than the dVS: 82/878 vs 39/991 and 100/878 vs 48/991, P < 0.001. Open conversion was more frequent with dV than dVS (19.3% vs 7.7% of reported malfunctions, P < 0.001), while patient injury was less with dV than dVS (3.5% vs 5.9%, P= 0.021). The dVS decreased console and patient-side cart errors relative to total malfunctions, which were also influenced by surgical year. Open conversions were

  16. Digital literacy knowledge and needs of pharmacy staff: A systematic review.

    PubMed

    MacLure, Katie; Stewart, Derek

    2016-10-07

    To explore the digital literacy knowledge and needs of pharmacy staff including pharmacists, graduate (pre-registration) pharmacists, pharmacy technicians, dispensing assistants and medicine counter assistants. A systematic review was conducted following a pre-published protocol. Two reviewers systematically performed the reproducible search, followed by independent screening of titles/abstracts then full papers, before critical appraisal and data extraction. Full articles matching the search terms were eligible for inclusion. Exclusions were recorded with reasons. Kirkpatrick's 4 level model of training evaluation (reaction, learning, behaviour and results) was applied as an analytical framework. Screening reduced the initial 86 papers to 5 for full review. Settings included hospital and community pharmacy plus education in Australia, Canada and the US. No studies of pharmacy staff other than pharmacists were identified. Main findings indicate that pharmacy staff lack digital literacy knowledge with minimal research evidenced at each level of Kirkpatrick's model. As a society, we acknowledge that technology is an important part of everyday life impacting on the efficiency and effectiveness of working practices but, in pharmacy, do we take cognisance, 'that technology can change the nature of work faster than people can change their skills'? It seems that pharmacy has embraced technology without recognised occupational standards, definition of baseline skills or related personal development plans. There is little evidence that digital literacy has been integrated into pharmacy staff training, which remains an under-researched area.

  17. 75 FR 31433 - Science Advisory Board Staff Office; Notification of a Public Meeting of the SAB Lead Review Panel

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-03

    ... AGENCY Science Advisory Board Staff Office; Notification of a Public Meeting of the SAB Lead Review Panel... (SAB) Staff Office announces a public meeting of the SAB Lead Review Panel to provide a consultation on EPA's draft technical analyses that will be used to support the development of lead-based paint dust...

  18. 77 FR 65728 - Final Interim Staff Guidance Augmenting NUREG-1537, “Guidelines for Preparing and Reviewing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-30

    ... COMMISSION Final Interim Staff Guidance Augmenting NUREG-1537, ``Guidelines for Preparing and Reviewing... Staff Guidance (ISG), that augments NUREG- 1537, Part 1, ``Guidelines for Preparing and Reviewing... NRC published for public comment Chapters 1-6 of the draft ISG, that augments NUREG-1537, Part...

  19. Do Studies Evaluating QT/QTc Interval Prolongation with Dietary Supplements Meet FDA Standards: A Systematic Review.

    PubMed

    Nguyen, Tinh An; Kurian, Amy; Leong, Jessica; Patel, Umang M; Shah, Sachin A

    2017-07-04

    Dietary supplement use is continuously increasing, but the safety evaluation of these products remains partial. While dietary supplements have no mandate for assessing cardiovascular safety, all new drug entities (NDE) are required to undergo a thorough QT/corrected QT (QTc) assessment to determine their propensity to impact cardiac repolarization. Independent investigators and manufacturers of dietary supplements voluntarily initiate safety studies; however, the quality of these studies is controversial. We sought to compare studies evaluating the QT/QTc effects of dietary supplements based on the International Conference of Harmonization (ICH)-E14 recommendations for NDE. Twenty-six published dietary supplement studies assessed QT/QTc interval prolongation. Sample sizes ranged from nine subjects to 206 among the 15 crossover studies, six parallel design studies, and five observational studies. A plan to account for electrocardiogram (ECG) morphological abnormalities was included in 10 studies, and two studies reported cardiovascular adverse events. Eight studies found a significant change in QT/QTc intervals. The majority of studies included in this review contained many of the critical elements recommended by the ICH E14, which includes the U.S. Food and Drug Administration guidance document for QT/QTc interval assessment. Compared with the thorough QT (TQT) standards, studies are typically well performed but can be bolstered by some study design changes. More than 30% of the included studies showed some degree of ECG changes, suggesting the need for continued cardiovascular safety assessment of dietary supplements.

  20. FDA 101: Regulating Biological Products

    MedlinePlus

    ... Home For Consumers Consumer Updates FDA 101: Regulating Biological Products Share Tweet Linkedin Pin it More sharing ... and highly important field. back to top What biological products does FDA regulate? The Center for Biologics ...

  1. Disaster Preparedness among Health Professionals and Support Staff: What is Effective? An Integrative Literature Review.

    PubMed

    Gowing, Jeremy R; Walker, Kim N; Elmer, Shandell L; Cummings, Elizabeth A

    2017-03-16

    Introduction It is important that health professionals and support staff are prepared for disasters to safeguard themselves and the community during disasters. There has been a significantly heightened focus on disasters since the terrorist attacks of September 11, 2001 in New York (USA); however, despite this, it is evident that health professionals and support staff may not be adequately prepared for disasters. Report An integrative literature review was performed based on a keyword search of the major health databases for primary research evaluating preparedness of health professionals and support staff. The literature was quality appraised using a mixed-methods appraisal tool (MMAT), and a thematic analysis was completed to identify current knowledge and gaps. Discussion The main themes identified were: health professionals and support staff may not be fully prepared for disasters; the most effective content and methods for disaster preparedness is unknown; and the willingness of health professionals and support staff to attend work and perform during disasters needs further evaluation. Gaps were identified to guide further research and the creation of new knowledge to best prepare for disasters. These included the need for: high-quality research to evaluate the best content and methods of disaster preparedness; inclusion of the multi-disciplinary health care team as participants; preparation for internal disasters; the development of validated competencies for preparedness; validated tools for measurement; and the importance of performance in actual disasters to evaluate preparation.

  2. Effectiveness of interventions targeting health behaviors in university and college staff: a systematic review.

    PubMed

    Plotnikoff, Ronald; Collins, Clare E; Williams, Rebecca; Germov, John; Callister, Robin

    2015-01-01

    Evaluate the literature on interventions targeting tertiary education staff within colleges and universities for improvements in health behaviors such as physical activity, dietary intake, and weight loss. One online database, Medline, was searched for literature published between January 1970 and February 2013. All quantitative study designs, including but not limited to randomized controlled trials, quasi-experimental studies, nonrandomized experimental trials, cohort studies, and case-control studies, were eligible. Data extraction was performed by one reviewer using a standardized form developed by the researchers. Extraction was checked for accuracy and consistency by a second reviewer. Data in relation to the above objective were extracted and described in a narrative synthesis. Seventeen studies were identified that focused on staff within the tertiary education setting. The review yielded overall positive results with 13 reporting significant health-related improvements. Weight loss, physical activity and fitness, and/or nutrition were the focus in more than half (n = 9) of the studies. This appears to be the first review to examine health interventions for tertiary education staff. There is scope to enhance cross-disciplinary collaboration in the development and implementation of a "Healthy University" settings-based approach to health promotion in tertiary education workplaces. Universities or colleges could serve as a research platform to evaluate such intervention strategies.

  3. Dementia training programmes for staff working in general hospital settings - a systematic review of the literature.

    PubMed

    Scerri, Anthony; Innes, Anthea; Scerri, Charles

    2017-08-01

    Although literature describing and evaluating training programmes in hospital settings increased in recent years, there are no reviews that summarise these programmes. This review sought to address this, by collecting the current evidence on dementia training programmes directed to staff working in general hospitals. Literature from five databases were searched, based on a number of inclusion criteria. The selected studies were summarised and data was extracted and compared using narrative synthesis based on a set of pre-defined categories. Methodological quality was assessed. Fourteen peer-reviewed studies were identified with the majority being pre-test post-test investigations. No randomised controlled trials were found. Methodological quality was variable with selection bias being the major limitation. There was a great variability in the development and mode of delivery although, interdisciplinary ward based, tailor-made, short sessions using experiential and active learning were the most utilised. The majority of the studies mainly evaluated learning, with few studies evaluating changes in staff behaviour/practices and patients' outcomes. This review indicates that high quality studies are needed that especially evaluate staff behaviours and patient outcomes and their sustainability over time. It also highlights measures that could be used to develop and deliver training programmes in hospital settings.

  4. Staff understanding of recovery-orientated mental health practice: a systematic review and narrative synthesis.

    PubMed

    Le Boutillier, Clair; Chevalier, Agnes; Lawrence, Vanessa; Leamy, Mary; Bird, Victoria J; Macpherson, Rob; Williams, Julie; Slade, Mike

    2015-06-10

    Mental health policy is for staff to transform their practice towards a recovery orientation. Staff understanding of recovery-orientated practice will influence the implementation of this policy. The aim of this study was to conduct a systematic review and narrative synthesis of empirical studies identifying clinician and manager conceptualisations of recovery-orientated practice. A systematic review of empirical primary research was conducted. Data sources were online databases (n = 8), journal table of contents (n = 5), internet, expert consultation (n = 13), reference lists of included studies and references to included studies. Narrative synthesis was used to integrate the findings. A total of 10,125 studies were screened, 245 full papers were retrieved, and 22 were included (participants, n = 1163). The following three conceptualisations of recovery-orientated practice were identified: clinical recovery, personal recovery and service-defined recovery. Service-defined recovery is a new conceptualisation which translates recovery into practice according to the goals and financial needs of the organisation. Organisational priorities influence staff understanding of recovery support. This influence is leading to the emergence of an additional meaning of recovery. The impact of service-led approaches to operationalising recovery-orientated practice has not been evaluated. The protocol for the review was pre-registered (PROSPERO 2013: CRD42013005942 ).

  5. A systematic review of staff training interventions to reduce the behavioural and psychological symptoms of dementia.

    PubMed

    Spector, Aimee; Orrell, Martin; Goyder, Judith

    2013-01-01

    Behavioural and psychological symptoms of dementia (BPSD) are highly prevalent and problematic in care settings. Given the limited effectiveness of medical treatments, training care staff to understand and manage these symptoms is essential for the safety and quality of life of people with dementia. This review evaluated the effectiveness of staff training interventions for reducing BPSD. A systematic literature search identified 273 studies. Twenty studies, published between 1998 and 2010, were found to meet the inclusion criteria. Overall, there was some evidence that staff training interventions can impact on BPSD: twelve studies resulted in significant symptom reductions, four studies found positive trends and four studies found no impact on symptoms. No links were found between the theoretical orientation of training programmes and their effectiveness. Training was also found to impact on the way staff behaved towards residents. A quality screening, using pre-specified criteria, revealed numerous methodological weaknesses and many studies did not adhere to the recommended guidelines for the conduct of cluster randomised controlled trials. There is an urgent need for more high quality research and evidence-based practice in BPSD.

  6. Nursing Staff Members Mental's Health and Factors Associated with the Work Process: An Integrative Review.

    PubMed

    Vasconcelos, Selene Cordeiro; Lopes de Souza, Sandra; Botelho Sougey, Everton; de Oliveira Ribeiro, Elayne Cristina; Costa do Nascimento, José Jailson; Formiga, Mariana Bandeira; Batista de Souza Ventura, Luciana; Duarte da Costa Lima, Murilo; Silva, Antonia Oliveira

    2016-01-01

    The mental health of nursing staff members influences the work process outcomes. Identify the work related factors that harms the nursing team's mental health. Databases PubMed, Scopus, CINAHL and MEDLINE, by mating between the indexed descriptors in MeSH terms "mental health" and "occupational health nursing". 783 articles were rescued to give a final sample of 18 articles. Integrative review in order to identify factors associated with the work process of the nursing staff that negatively affects mental health. The main associated factors were work demands, psychological demands, violence, aggression, poor relationships with administrators, accidents involving the risk of exposure to HIV, stress and errors in the execution of labor activities. The main findings regarding the nursing staff's mental health were post-traumatic stress disorder, depression, stress, major depressive episode and generalized anxiety disorder. Occupational nurses need to understand the complexities of mental health problems and substance use among nursing staff members to recognize, identify and care for workers at risk and offer adequate mental health care. Although the researches interests in this theme have increased, proving that all these factors contribute to the risk to mental health of nursing professionals, the protective measures and care are being neglected by managers in both private and public network . The health of nursing workers in question here is one more challenge for a profession that takes care of others in need, therefore, requires some caring with their own health.

  7. An education initiative to increase staff knowledge of Institutional Review Board guidelines in the USA.

    PubMed

    Kotzer, Anne Marie; Milton, Jerrod

    2007-06-01

    Health-care professionals and researchers often lack a clear understanding of the role and function of an Institutional Review Board (IRB) and few have received formal education regarding IRB guidelines, policies, and procedures. The purpose of this study was to develop an initiative to educate staff concerning fundamental IRB guidelines and to assess the retention of the information from the educational intervention with a pretest and post-test. Using a descriptive survey design, 643 professional staff were contacted by email and asked to complete an online survey. Thereafter, staff received a "10 Second IRB Update" every 2 weeks for 6 months, after which the initial survey was repeated. Although there was a slight improvement in the pretest/post-test scores for some groups, no statistically significant differences were seen. Anecdotally, staff expressed enthusiasm about the initiative, stating the updates were very effective and a great teaching tool. The findings emphasize the need to continue to explore creative approaches to education regarding IRB policies and procedures.

  8. K-12 School Food Service Staff Training Interventions: A Review of the Literature.

    PubMed

    Stephens, Lacy; Byker Shanks, Carmen

    2015-12-01

    School food service professionals are vital to implementing national nutrition standards in school meal programs. Appropriate and effective training for these professionals may be one key to producing healthful meals that students are excited to eat and also meet United States Department of Agriculture (USDA) nutrient guidelines. A systematic literature review was conducted to understand the scope of interventions conducted with food service staff. PubMed, Web of Knowledge, and Science Direct databases were searched for articles detailing school food service training interventions in K-12 school settings within the United States. Of 2341 articles retrieved, 17 articles describing 14 food service training interventions met the inclusion criteria. While food service staff training was an important component of many comprehensive school health and school meal interventions, there were few studies that specifically addressed school food service staff trainings. Although some best practices can be concluded from the current literature, major gaps in knowledge about effective school food service training interventions and validated research tools remain. As new professional standards are mandated by the USDA, a more thorough evaluation and understanding of best practices is vital to maximize the effectiveness of food service staff training. © 2015, American School Health Association.

  9. What Can Be Learned from Recent New Drug Applications? A Systematic Review of Drug Interaction Data for Drugs Approved by the US FDA in 2015.

    PubMed

    Yu, Jingjing; Zhou, Zhu; Owens, Katie H; Ritchie, Tasha K; Ragueneau-Majlessi, Isabelle

    2017-01-01

    As a follow up to previous reviews, the aim of the present analysis was to systematically examine all drug metabolism, transport, pharmacokinetics (PK), and drug-drug interaction (DDI) data available in the 33 new drug applications (NDAs) approved by the Food and Drug Administration (FDA) in 2015, using the University of Washington Drug Interaction Database, and to highlight the significant findings. In vitro, a majority of the new molecular entities (NMEs) were found to be substrates or inhibitors/inducers of at least one drug metabolizing enzyme or transporter. In vivo, 95 clinical DDI studies displayed positive PK interactions, with an area under the curve (AUC) ratio ≥ 1.25 for inhibition or ≤ 0.8 for induction. When NMEs were considered as victim drugs, 21 NMEs had at least one positive clinical DDI, with three NMEs shown to be sensitive substrates of CYP3A (AUC ratio ≥ 5 when coadministered with strong inhibitors): cobimetinib, isavuconazole (the active metabolite of prodrug isavuconazonium sulfate), and ivabradine. As perpetrators, nine NMEs showed positive inhibition and three NMEs showed positive induction, with some of these interactions involving both enzymes and transporters. The most significant changes for inhibition and induction were observed with rolapitant, a moderate inhibitor of CYP2D6 and lumacaftor, a strong inducer of CYP3A. Physiologically based pharmacokinetics simulations and pharmacogenetics studies were used for six and eight NMEs, respectively, to inform dosing recommendations. The effects of hepatic or renal impairment on the drugs' PK were also evaluated to support drug administration in these specific populations.

  10. 76 FR 29746 - Science Advisory Board Staff Office Notification of a Public Meeting of the SAB Mercury Review Panel

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-23

    ... AGENCY Science Advisory Board Staff Office Notification of a Public Meeting of the SAB Mercury Review... SAB Mercury Review Panel. DATES: The meeting will be held on June 15, 2011 and June 16, 2011 from 9 a... Mercury Review Panel will hold a public meeting to review EPA's Technical Support Document:...

  11. 75 FR 71701 - Science Advisory Board Staff Office; Request for Nominations of Experts for the Review of a Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-24

    ... AGENCY Science Advisory Board Staff Office; Request for Nominations of Experts for the Review of a Draft... Protection Agency (EPA). ACTION: Notice. SUMMARY: The EPA Science Advisory Board (SAB) Staff Office is...-2098, or via e-mail at carpenter.thomas@epa.gov . General information concerning the EPA...

  12. Epidural steroid warning controversy still dogging FDA.

    PubMed

    Manchikanti, Laxmaiah; Candido, Kenneth D; Singh, Vijay; Gharibo, Christopher G; Boswell, Mark V; Benyamin, Ramsin M; Falco, Frank J E; Grider, Jay S; Diwan, Sudhir; Hirsch, Joshua A

    2014-01-01

    On April 23, 2014, the Food and Drug Administration (FDA) issued a letter of warning that injection of corticosteroids into the epidural space of the spine may result in rare, but serious adverse events, including "loss of vision, stroke, paralysis, and death." The advisory also advocated that patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments. In addition, the FDA stated that the effectiveness and safety of the corticosteroids for epidural use have not been established, and the FDA has not approved corticosteroids for such use. To raise awareness of the risks of epidural corticosteroid injections in the medical community, the FDA's Safe Use Initiative convened a panel of experts including pain management experts to help define the techniques for such injections with the aim of reducing preventable harm. The panel was unable to reach an agreement on 20 proposed items related to technical aspects of performing epidural injections. Subsequently, the FDA issued the above referenced warning and a notice that a panel will be convened in November 2014. This review assesses the inaccuracies of the warning and critically analyzes the available literature. The literature has been assessed in reference to alternate techniques and an understanding of the risk factors when performing transforaminal epidural injections in the cervical, thoracic, and lumbar regions, ultimately resulting in improved safety. The results of this review show the efficacy of epidural injections, with or without steroids, in a multitude of spinal ailments utilizing caudal, cervical, thoracic, and lumbar interlaminar approaches as well as lumbar transforaminal epidural injections . The evidence also shows the superiority of steroids in managing lumbar disc herniation utilizing caudal and lumbar interlaminar approaches without any significant difference as

  13. Forensic psychiatric nursing: a literature review and thematic analysis of staff-patient interaction.

    PubMed

    Gildberg, F A; Elverdam, B; Hounsgaard, L

    2010-05-01

    In Denmark the increasing number of forensic mental health patients has led to prioritized services, including the area of nursing; however, this field is subject to sparse research. The aim of this study was to review existing research literature and in doing so investigate what characterizes forensic mental health staff interaction with forensic mental health inpatients and furthermore to investigate what significance these staff characteristics have for the inpatients. The literature review spans the period September 1997 to January 2009 and was based on a systematic keyword combination search in the following databases: CINAHL, CSB, PsycINFO, Scopus, Pubmed, MEDLINE and Sociological Abstracts. The articles were categorized using a literature matrix and analysed using content analysis. Seventeen quantitative and qualitative research studies were analysed. The results show that the interaction between forensic staff and forensic inpatients is characterized by two overriding themes: parentalistic & behaviour-changing care and relational & personal quality-dependent care. Only a few of the findings represent a clear account of how the interactional characteristics impact on the forensic inpatient. The conclusion is that no clear account of the patient impact issue can be reached at this point and that further investigation needs to take place.

  14. A review of the progress and pitfalls of FDA policy process: Planning a pathway for pharmaceutical interventions for hearing loss development.

    PubMed

    Hammill, Tanisha L

    2017-06-01

    The Federal Food and Drug Administration, or FDA is generally considered a powerful gatekeeper, able to deliver or withhold life-saving cures and create or destroy economic windfalls. As the decades go by, and technologies, diseases, public health demands, and politics evolve, we can identify patterns of change, action and inter-action among some of these traditional stakeholders in the FDA's policy sphere. A careful examination of this agency's colorful history can shed light on central features of the agency's policy process, which has been quite receptive to its stakeholders and adaptive to change over the decades and, in turn, show the way for development in lanes which do not fit neatly into the current paradigms offered by the agency. This paper will explore the history of FDA policy process, through examination of seminal moments in FDA history, the prominent actors and focusing events within them, and the outcomes of those events, in an attempt to illuminate a pattern of behavior or processes by which a struggling field of pharmaceutical development such as interventions for hearing loss can advance. Copyright © 2016 Elsevier B.V. All rights reserved.

  15. FDA's evolving approach to nanotechnology.

    PubMed

    Monica, John C

    2012-01-01

    Nanotechnology has emerged as an industry with the potential to change many products regulated by the FDA. While the FDA has been regulating products containing nanoscale materials for several years, questions concerning the effectiveness of existing regulations have emerged. After a period of study and analysis, the FDA has issued three (3) draft guidance documents over the last eighteen (18) months pertaining to the use of nanoscale materials and nanotechnology in certain FDA-regulated products. As these are likely to become the "de facto" standards they merit further analysis. This article examines these draft guidance documents and provides modest commentary for those practicing in the area.

  16. Constructive staff-family relationships in the care of older adults in the institutional setting: A systematic review.

    PubMed

    Haesler, Emily; Bauer, Michael; Nay, Rhonda

    2004-01-01

    Modern health care philosophy espouses the virtues of holistic care and acknowledges that family involvement is appropriate and something to be encouraged due to the role it plays in physical and emotional healing. In the aged care sector, the involvement of families is a strong guarantee of a resident's wellbeing. The important role family plays in the support and care of the older adult in the residential aged care environment has been enshrined in the Australian Commonwealth Charter of Residents' Rights and Responsibilities and the Aged Care Standards of Practice. Despite wide acknowledgement of the importance of family imvolvement in the health care of the older adult, many barriers to the implementation of participatory family care have been identified in past research. For older adults in the health care environment to benefit from the involvement of their family members, health care professionals need an understanding of the issues surrounding family presence in the health care environement and the strategies to best support it. The objectives of the systematic review were to present the best available evidence on the strategies, practices and organisational characteristics that promote constructive staff-family relationships in the care of older adults in the health care setting. Specifically this review sought to investigate how staff and family members perceive their relationships with each other; staff characteristics that promote constructive relationships with the family; and interventions that support staff-family relationships. A literature search was performed using the following databases for the years 1990-2005: Ageline, APAIS Health, Australian Family & Society Abstracts (FAMILY), CINAHL, Cochrane Library, Dare, Dissertation Abstracts, Embase, MEDLINE, PsycINFO, and Social Science Index. Personal communication from expert panel members was also used to identify studies for inclusion. A second search stage was conducted through review of reference

  17. Precipitants to psychiatric patient assaults on staff: review of empirical findings, 1990-2003, and risk management implications.

    PubMed

    Flannery, Raymond B

    2005-01-01

    Psychiatric patient assaults on staff are a serious and continuing problem in health care settings. Over thirty years of empirical research have documented the characteristics of both patient assailants and staff victims. Notably absent from this literature have been similar empirical studies on the nature of patient precipitants to these assaults. This paper reviewed empirical studies of patient assault precipitants from 1990-2003. Six studies from three countries were reviewed. Common precipitants included staff restrictions on patient behaviors, denial of services, excessive sensory overload, and provocation by others. The clinical, methodological, and risk management implications are examined.

  18. FDA toxicity databases and real-time data entry

    SciTech Connect

    Arvidson, Kirk B.

    2008-11-15

    Structure-searchable electronic databases are valuable new tools that are assisting the FDA in its mission to promptly and efficiently review incoming submissions for regulatory approval of new food additives and food contact substances. The Center for Food Safety and Applied Nutrition's Office of Food Additive Safety (CFSAN/OFAS), in collaboration with Leadscope, Inc., is consolidating genetic toxicity data submitted in food additive petitions from the 1960s to the present day. The Center for Drug Evaluation and Research, Office of Pharmaceutical Science's Informatics and Computational Safety Analysis Staff (CDER/OPS/ICSAS) is separately gathering similar information from their submissions. Presently, these data are distributed in various locations such as paper files, microfiche, and non-standardized toxicology memoranda. The organization of the data into a consistent, searchable format will reduce paperwork, expedite the toxicology review process, and provide valuable information to industry that is currently available only to the FDA. Furthermore, by combining chemical structures with genetic toxicity information, biologically active moieties can be identified and used to develop quantitative structure-activity relationship (QSAR) modeling and testing guidelines. Additionally, chemicals devoid of toxicity data can be compared to known structures, allowing for improved safety review through the identification and analysis of structural analogs. Four database frameworks have been created: bacterial mutagenesis, in vitro chromosome aberration, in vitro mammalian mutagenesis, and in vivo micronucleus. Controlled vocabularies for these databases have been established. The four separate genetic toxicity databases are compiled into a single, structurally-searchable database for easy accessibility of the toxicity information. Beyond the genetic toxicity databases described here, additional databases for subchronic, chronic, and teratogenicity studies have been prepared.

  19. Improving Patient Outcomes: Effectively Training Healthcare Staff in Psychological Practice Skills: A Mixed Systematic Literature Review

    PubMed Central

    Garzonis, Katherine; Mann, Eryn; Wyrzykowska, Aleksandra; Kanellakis, Pavlo

    2015-01-01

    Training is an important part of modern European healthcare services and is often cited as a way to improve care quality. To date, various training methods have been used to impart skills relevant to psychological practice in a variety of mental health professionals. However, patient outcomes are rarely used in evaluating the effectiveness of the different training methods used, making it difficult to assess true utility. In the present review, we consider methods of training that can effectively impact trainee and patient outcomes. To do so, PubMed, PsycNET, Scopus, CENTRAL and ERIC were searched for studies on training of healthcare staff in psychological practice approaches. In total, 24 studies were identified (16 quantitative and 8 qualitative). For the most part, group, individual, and web-based training was used. A variety of health professionals were trained in skills including ‘communication’, ‘diagnosis’, and ‘referral’ to name but a few. In the majority of studies staff skill level improved. These findings hold implications for the design, implementation, and evaluation of training for mental healthcare staff. PMID:27247676

  20. NRC staff review of licensee responses to pressure-locking and thermal-binding issue

    SciTech Connect

    Rathbun, H.J.

    1996-12-01

    Commercial nuclear power plant operating experience has indicated that pressure locking and thermal binding represent potential common mode failure mechanisms that can cause safety-related power-operated gate valves to fail in the closed position, thus rendering redundant safety-related systems incapable of performing their safety functions. In Generic Letter (GL) 95-07, {open_quotes}Pressure Locking and Thermal Binding of Safety-Related Power-Operated Gate Valves,{close_quotes} the U.S. Nuclear Regulatory Commission (NRC) staff requested that nuclear power plant licensees take certain actions to ensure that valves susceptible to pressure locking or thermal binding are capable of performing their safety functions within the current licensing bases of the facility. The NRC staff has received summary information from licensees in response to GL 95-07 describing actions they have taken to prevent the occurrence of pressure locking and thermal binding. The NRC staff has developed a systematic process to help ensure uniform and consistent review of licensee submittals in response to GL 95-07.

  1. Radiation exposure of eyes, thyroid gland and hands in orthopaedic staff: a systematic review.

    PubMed

    Kesavachandran, Chandrasekharan Nair; Haamann, Frank; Nienhaus, Albert

    2012-10-30

    Various procedures, especially minimal invasive techniques using fluoroscopy, pose a risk of radiation exposure to orthopaedic staff. Anatomical sites such as the eyes, thyroid glands and hands are more vulnerable to radiation considering the limited use of personal protective devices in the workplace. The objective of the study is to assess the annual mean cumulative and per procedure radiation dose received at anatomical locations like eyes, thyroid glands and hands in orthopaedic staff using systematic review. The review of literature was conducted using systematic search of the database sources like PUBMED and EMBASE using appropriate keywords. The eligibility criteria and the data extraction of literature were based on study design (cohort or cross-sectional study), study population (orthopaedic surgeons or their assistants), exposure (doses of workplace radiation exposure at hands/fingers, eye/forehead, neck/thyroid), language (German and English). The literature search was conducted using a PRISMA checklist and flow chart. Forty-two articles were found eligible and included for the review. The results show that radiation doses for the anatomical locations of eye, thyroid gland and hands were lower than the dose levels recommended. But there is a considerable variation of radiation dose received at all three anatomical locations mainly due to different situations including procedures (open and minimally invasive), work experience (junior and senior surgeons),distance from the primary and secondary radiation, and use of personal protective equipments (PPEs). The surgeons receive higher radiation dose during minimally invasive procedures compared to open procedures. Junior surgeons are at higher risk of radiation exposure compared to seniors. PPEs play a significant role in reduction of radiation dose. Although the current radiation precautions appear to be adequate based on the low dose radiation, more in-depth studies are required on the variations of

  2. A Guide to the FDA.

    ERIC Educational Resources Information Center

    Miller, Annetta K.

    The United States Food and Drug Administration (FDA) collects information in seven areas: foods, cosmetics, human drugs, animal drugs and feeds, medical devices, biologics, and electronic radiological products. By using procedures outlined in the Freedom of Information Act, the public may get specific information from such FDA files as inspection…

  3. A Guide to the FDA.

    ERIC Educational Resources Information Center

    Miller, Annetta K.

    The United States Food and Drug Administration (FDA) collects information in seven areas: foods, cosmetics, human drugs, animal drugs and feeds, medical devices, biologics, and electronic radiological products. By using procedures outlined in the Freedom of Information Act, the public may get specific information from such FDA files as inspection…

  4. Is It Really FDA Approved?

    MedlinePlus

    ... tissue. back to top FDA doesn’t approve tobacco products. There’s no such thing as a safe tobacco product, so FDA’s safe and effective standard for evaluating medical products is not appropriate for tobacco products. Instead, FDA regulates tobacco products based on ...

  5. Examining the FDA's oversight of direct-to-consumer advertising.

    PubMed

    Gahart, Martin T; Duhamel, Louise M; Dievler, Anne; Price, Roseanne

    2003-01-01

    Our analysis examined the effects of the Food and Drug Administration's (FDA's) 1997 draft guidance regarding advertisements for prescription drugs broadcast directly to consumers. We found that although direct-to-consumer (DTC) advertising spending by pharmaceutical companies has increased, more than 80 percent of their promotional spending is directed to physicians. DTC advertising appears to increase the use of prescription drugs among consumers. The FDA's oversight has not prevented companies from making misleading claims in subsequent advertisements, and a recent policy change has lengthened the FDA's review process, raising the possibility that some misleading campaigns could run their course before review.

  6. 75 FR 68009 - Office of New Reactors; Notice of Availability of the Final Staff Guidance Standard Review Plan...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-04

    ... Reactors; Notice of Availability of the Final Staff Guidance Standard Review Plan Section 13.6.2, Revision 1 on Physical Security--Design Certification AGENCY: Nuclear Regulatory Commission (NRC). ACTION: Notice of Availability. SUMMARY: The NRC is issuing its Final Revision 1 to NUREG-0800, ``Standard Review...

  7. Regulating nanomedicine - can the FDA handle it?

    PubMed

    Bawa, Raj

    2011-05-01

    There is enormous excitement and expectation surrounding the multidisciplinary field of nanomedicine - the application of nanotechnology to healthcare - which is already influencing the pharmaceutical industry. This is especially true in the design, formulation and delivery of therapeutics. Currently, nanomedicine is poised at a critical stage. However, regulatory guidance in this area is generally lacking and critically needed to provide clarity and legal certainty to manufacturers, policymakers, healthcare providers as well as public. There are hundreds, if not thousands, of nanoproducts on the market for human use but little is known of their health risks, safety data and toxicity profiles. Less is known of nanoproducts that are released into the environment and that come in contact with humans. These nanoproducts, whether they are a drug, device, biologic or combination of any of these, are creating challenges for the Food and Drug Administration (FDA), as regulators struggle to accumulate data and formulate testing criteria to ensure development of safe and efficacious nanoproducts (products incorporating nanoscale technologies). Evidence continues to mount that many nanoproducts inherently posses novel size-based properties and toxicity profiles. Yet, this scientific fact has been generally ignored by the FDA and the agency continues to adopt a precautionary approach to the issue in hopes of countering future potential negative public opinion. As a result, the FDA has simply maintained the status quo with regard to its regulatory policies pertaining to nanomedicine. Therefore, there are no specific laws or mechanisms in place for oversight of nanomedicine and the FDA continues to treat nanoproducts as substantially equivalent ("bioequivalent") to their bulk counterparts. So, for now nanoproducts submitted for FDA review will continue to be subjected to an uncertain regulatory pathway. Such regulatory uncertainty could negatively impact venture funding, stifle

  8. Dementia-specific training for nursing home staff : A systematic literature review.

    PubMed

    Riesch, Julia; Meyer, Lucy; Lehr, Bosco; Severin, Thomas

    2017-08-22

    For people with dementia high-quality care is vital, since at present dementia cannot be cured. In nursing homes this care is provided by the staff, who therefore require dementia-specific training enabling them to improve the quality of life for people with dementia. This article compares existing dementia-specific training for nursing home staff with recommendations, based on the current state of research, by the Alzheimer's Association and the National Institute for Health and Care Excellence, and discusses the outcome of this training. A systematic review of the literature was conducted to identify studies addressing dementia-specific training. The electronic databases Embase, Medline, Cochrane, CINAHL, PsychINFO, PSYNDEX, and ScienceDirect were searched. The training topics most commonly considered were person-centered care, communicating with people affected by dementia, and information about dementia. The roles of different social and healthcare professionals, palliative care of people with dementia, and understanding family dynamics are least featured in the training. There are training concepts which focus not only on the transfer of knowledge but also on practical exercises. In general, the recommended topics were addressed in dementia-specific training concepts, but there is potential for optimization. Further research is needed to identify success criteria in dementia-specific training and identify the successful combination of theoretical knowledge and practical exercise.

  9. A Review of Radiation Protection Requirements and Dose Estimation for Staff and Patients in CT Fluoroscopy.

    PubMed

    Teles, P; Nikodemová, D; Bakhanova, E; Becker, F; Kneževic, Ž; Pereira, M F; Sarmento, S

    2017-05-01

    The combination of fluoroscopically guided interventional procedures with computed tomography (CTF) has become widespread around the world. The benefits of CTF include the ability to obtain a real-time visualization of the entire body, increased target accuracy and improved visualization of biopsy needles. Modern CTF units work with variable frame rates for image selection, and therefore the dose distributions for patients and staff can considerably vary, creating growing concern in terms of the occupational exposure of interventionists and the drawback of a higher exposure of the patient. A literature review of the latest CTF publications is summarized in this article. A wide range of CTF studies reveal different treatment methods used in clinical practice, and therefore the differences in the exposures between them; as well as in the radiation protection tools and dose monitoring. Further optimization of radiation protection methods, harmonization of exposure patterns as well as training and education of CTF staff on the basis of the information in the survey, are strongly recommended. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  10. Induction training, career counselling, and performance review: views of junior medical staff.

    PubMed

    Williams, J G; Cheung, W Y

    1998-07-01

    Surveys of senior house officers and registrars were undertaken by postal questionnaire to ascertain views on the need for and content of induction training, career counselling, and performance review. The questionnaire was sent out in May 1990 and repeated in May 1996, after measures had been taken to improve induction training, and assessment and appraisal of trainees. In 1990 there was a clear wish to receive information on career prospects, research and education opportunities, and clinical audit, but more ambivalence regarding information or training in communication, discharge policies, standards, and encoding procedures. There was also a firm view that career counselling could be improved and formal goal setting and performance appraisal interviews would be welcomed. In 1996 there was disappointingly little change in the views expressed by the junior medical staff, though there was a significant increase in confidence in the role of the consultant in career counselling.

  11. The influence of staff training and education on prosthetic and orthotic service quality: A scoping review.

    PubMed

    Forghany, Saeed; Sadeghi-Demneh, Ebrahim; Trinler, Ursula; Onmanee, Pornsuree; Dillon, Michael P; Baker, Richard

    2017-07-01

    Education and training in prosthetics and orthotics typically comply with International Society for Prosthetics and Orthotics standards based on three categories of prosthetic and orthotic professionals. This scoping study sought to describe the evidence base available to answer the question, How are prosthetic and orthotic services influenced by the training of staff providing them? Scoping review. A structured search of the peer-reviewed literature catalogued in major electronic databases yielded 3039 papers. Following review of title and abstract, 93 articles were considered relevant. Full-text review reduced this number to 25. Only two articles were identified as providing direct evidence of the effects of training and education on service provision. While both suggested that there was an impact, it is difficult to see how the more specific conclusions of either could be generalised. The other 23 articles provide a useful background to a range of issues including the specification of competencies that training programmes should deliver (3 articles), descriptions of a range of training programmes and the effects of training and education on student knowledge and skills. Although it is considered axiomatic, the service quality is dependent on practitioner education and training. There is insufficient evidence to establish whether levels of training and education in prosthetics and orthotics have an effect on the quality of prosthetic and orthotic services. Clinical relevance There is very little evidence about the effects of training and education of prosthetists and orthotists on service quality. While this is a somewhat negative finding, we feel that it is important to bring this to the attention of the prosthetics and orthotics community.

  12. 76 FR 72725 - Draft License Renewal Interim Staff Guidance LR-ISG-2011-05: Ongoing Review of Operating Experience

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-25

    ... Experience AGENCY: Nuclear Regulatory Commission. ACTION: Revision of draft interim staff guidance; request... Guidance (LR-ISG), LR-ISG-2011-05, ``Ongoing Review of Operating Experience.'' This LR-ISG provides... experience as an attribute of aging management programs used at nuclear power plants. As noticed on September...

  13. Institutional Staff Training and Management: A Review of the Literature and a Model for Geriatric, Long-Term-Care Facilities.

    ERIC Educational Resources Information Center

    Burgio, Louis D.; Burgio, Kathryn L.

    1990-01-01

    Asserts that, if long-term care is to progress from custodial model to therapeutic model of rehabilitation, role of nursing assistants must be redesigned. Reviews current methods of institutional staff training and management and proposes model for geriatric, long-term care facilities. Discusses organizational resistance and offers suggestions for…

  14. 76 FR 24888 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-03

    ... the ``Guidance for Industry and FDA Staff-- Section 905(j) Reports: Demonstrating Substantial... Office of Management and Budget Review; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products AGENCY...

  15. Systematic review of the effective components of psychosocial interventions delivered by care home staff to people with dementia

    PubMed Central

    Rapaport, Penny; Livingston, Gill; Murray, Joanna; Mulla, Aasiya; Cooper, Claudia

    2017-01-01

    Objectives This review aims to understand what elements of psychosocial interventions are associated with improved outcomes for people with dementia to inform implementation in care homes. Design A systematic review of qualitative and quantitative intervention studies was undertaken. Eligibility criteria for included studies We included primary research studies evaluating psychosocial interventions that trained care home staff to deliver a specific intervention or that sought to change how staff delivered care to residents with dementia and reported staff and resident qualitative or quantitative outcomes. Methods We searched MEDLINE, PsychINFO and EMBASE electronic databases and hand-searched references up to May 2016. Quality of included papers was rated independently by 2 authors, using operationalised checklists derived from standard criteria. We discussed discrepancies and reached consensus. We conducted a narrative synthesis of quantitative and a thematic synthesis of qualitative findings to find what was effective immediately and in sustaining change. Results We identified 49 papers fulfilling predetermined criteria. We found a lack of higher quality quantitative evidence that effects could be sustained after psychosocial interventions finished with no evidence that interventions continued to work after 6 months. Qualitative findings suggest that staff valued interventions focusing on getting to know, understand and connect with residents with dementia. Successful elements of interventions included interactive training, post-training support, aiming to train most staff, retaining written materials afterwards and building interventions into routine care. Conclusions Psychosocial interventions can improve outcomes for staff and residents with dementia in care homes; however, many trial results are limited. Synthesis of qualitative findings highlight core components of interventions that staff value and feel improve care. These findings provide useful evidence

  16. FDA regulation of tobacco: blessing or curse for FDA professionals?

    PubMed

    O'Reilly, James T

    2009-01-01

    Upwards of 400,000 Americans will die that year from the effects of cigarettes, which FDA will now "regulate" very gently, with its hands tied by a slick statutory protection for the largest existing tobacco marketers. Career FDA professionals will be criticized as enablers of mega-marketers' continued sales, working at the margins, arranging the paperwork for protection of megafirms' market share, and sitting by as the deaths and addictive behaviors continue. "Join the Public Health Service, inspired by a public health mission," they were told, and yet they will be unable to do much regulating of the addictive and fatal products for which they now have titular responsibility. This essay observes that these fine FDA professionals are handed the sticky remains of a messy bargain, negotiated in a distracted Congress by expensive lawyers with clients who were potent contributors to political action committees. The only formula that is not secret about the 2009 law is the way in which industry purchased sufficient allegiance to gather the votes for its adoption. The remaining mystery is how FDA could be expected to do these tasks without losing its best and brightest professionals to other fields.

  17. A Review of Medication Reconciliation Issues and Experiences with Clinical Staff and Information Systems

    PubMed Central

    Porcelli, P.J.; Waitman, L.R.; Brown, S.H.

    2010-01-01

    Medication reconciliation was developed to reduce medical mistakes and injuries through a process of creating and comparing a current medication list from independent patient information sources, and resolving discrepancies. The structure and clinician assignments of medication reconciliation varies between institutions, but usually includes physicians, nurses and pharmacists. The Joint Commission has recognized the value of medication reconciliation and mandated implementation in 2006; however, a variety of issues have prevented simple, easy, and universal implementation. This review references issues related to the development and the implementation of medication reconciliation including: – the need of a system or standard for accurate drug identification to create a definitive ‘gold standard’ patient medication list, – identifying stakeholders of medication reconciliation within the institution and contrasting staff interest and participation with institutional resources, – observations and opportunities of integrating medication reconciliation with the electronic patient health record, and – summarizing a series of institutions experiences developing and implementing medication reconciliation. Last, as medication reconciliation becomes a regular process within medical centers, key concepts for effective implementation are discussed. PMID:23616853

  18. The Influence of Staff Training on Challenging Behaviour in Individuals with Intellectual Disability: A Review

    ERIC Educational Resources Information Center

    Cox, Alison D.; Dube, Charmayne; Temple, Beverley

    2015-01-01

    Many individuals with intellectual disability engage in challenging behaviour. This can significantly limit quality of life and also negatively impact caregivers (e.g., direct care staff, family caregivers and teachers). Fortunately, efficacious staff training may alleviate some negative side effects of client challenging behaviour. Currently, a…

  19. The Influence of Staff Training on Challenging Behaviour in Individuals with Intellectual Disability: A Review

    ERIC Educational Resources Information Center

    Cox, Alison D.; Dube, Charmayne; Temple, Beverley

    2015-01-01

    Many individuals with intellectual disability engage in challenging behaviour. This can significantly limit quality of life and also negatively impact caregivers (e.g., direct care staff, family caregivers and teachers). Fortunately, efficacious staff training may alleviate some negative side effects of client challenging behaviour. Currently, a…

  20. A Systematic Review of Interventions to Change Staff Care Practices in Order to Improve Resident Outcomes in Nursing Homes

    PubMed Central

    Low, Lee-Fay; Fletcher, Jennifer; Goodenough, Belinda; Jeon, Yun-Hee; Etherton-Beer, Christopher; MacAndrew, Margaret; Beattie, Elizabeth

    2015-01-01

    Background We systematically reviewed interventions that attempted to change staff practice to improve long-term care resident outcomes. Methods Studies met criteria if they used a control group, included 6 or more nursing home units and quantitatively assessed staff behavior or resident outcomes. Intervention components were coded as including education material, training, audit and feedback, monitoring, champions, team meetings, policy or procedures and organizational restructure. Results Sixty-three unique studies were broadly grouped according to clinical domain—oral health (3 studies), hygiene and infection control (3 studies), nutrition (2 studies), nursing home acquired pneumonia (2 studies), depression (2 studies) appropriate prescribing (7 studies), reduction of physical restraints (3 studies), management of behavioral and psychological symptoms of dementia (6 studies), falls reduction and prevention (11 studies), quality improvement (9 studies), philosophy of care (10 studies) and other (5 studies). No single intervention component, combination of, or increased number of components was associated with greater likelihood of positive outcomes. Studies with positive outcomes for residents also tended to change staff behavior, however changing staff behavior did not necessarily improve resident outcomes. Studies targeting specific care tasks (e.g. oral care, physical restraints) were more likely to produce positive outcomes than those requiring global practice changes (e.g. care philosophy). Studies using intervention theories were more likely to be successful. Program logic was rarely articulated, so it was often unclear whether there was a coherent connection between the intervention components and measured outcomes. Many studies reported barriers relating to staff (e.g. turnover, high workload, attitudes) or organizational factors (e.g. funding, resources, logistics). Conclusion Changing staff practice in nursing homes is possible but complex

  1. FDA Warns About Stem Cell Claims

    MedlinePlus

    ... Home For Consumers Consumer Updates FDA Warns About Stem Cell Claims Share Tweet Linkedin Pin it More sharing ... blood-forming system. back to top Regulation of Stem Cells FDA regulates stem cells in the U.S. to ...

  2. Pharmaceutical trademarks: navigating through the FDA's pilot program.

    PubMed

    Ferrer, Elisa

    2010-06-01

    Creation and clearance of pharmaceutical trademarks continues to be one of the most difficult and challenging areas of trademark law. The Food and Drug Administration (FDA) recently initiated a 2-year Pilot Program under Prescription Drug User Fee Act (PDUFA) IV. The intent of the program is to enable participating pharmaceutical firms to evaluate proposed pharmaceutical marks and submit the data generated from those evaluations to the FDA for review. Submitting a trademark to the FDA warrants questions: What supporting data is needed and accepted when proposing a mark? What issues might arise, and how can they be averted? In a recent Thomson Reuters on-demand webinar (http://science.thomsonreuters.com/news/2010-02/8580404/), a group of renowned experts in the field of trademark development review the FDA pilot program, outline the requirements for submission and discuss what the changes will mean in clearing new pharmaceutical marks. They also present various approaches to trademark development and evaluation in light of the FDA's views.

  3. Reduce, Manage or Cope: A Review of Strategies for Training School Staff to Address Challenging Behaviours Displayed by Students with Intellectual/Developmental Disabilities

    ERIC Educational Resources Information Center

    Stoesz, Brenda M.; Shooshtari, Shahin; Montgomery, Janine; Martin, Toby; Heinrichs, Dustin J.; Douglas, Joyce

    2016-01-01

    Members of a knowledge translation and exchange (KTE) research team assessed the training needs of the teaching staff at a school for individuals with intellectual/developmental disabilities (IDD). In response to this need, KTE researchers retrieved peer-reviewed articles for training staff working with individuals with IDD who exhibit challenging…

  4. Reduce, Manage or Cope: A Review of Strategies for Training School Staff to Address Challenging Behaviours Displayed by Students with Intellectual/Developmental Disabilities

    ERIC Educational Resources Information Center

    Stoesz, Brenda M.; Shooshtari, Shahin; Montgomery, Janine; Martin, Toby; Heinrichs, Dustin J.; Douglas, Joyce

    2016-01-01

    Members of a knowledge translation and exchange (KTE) research team assessed the training needs of the teaching staff at a school for individuals with intellectual/developmental disabilities (IDD). In response to this need, KTE researchers retrieved peer-reviewed articles for training staff working with individuals with IDD who exhibit challenging…

  5. Education and training to enhance end-of-life care for nursing home staff: a systematic literature review

    PubMed Central

    Anstey, Sally; Powell, Tom; Coles, Bernadette; Hale, Rachel; Gould, Dinah

    2016-01-01

    Background The delivery of end-of-life care in nursing homes is challenging. This situation is of concern as 20% of the population die in this setting. Commonly reported reasons include limited access to medical care, inadequate clinical leadership and poor communication between nursing home and medical staff. Education for nursing home staff is suggested as the most important way of overcoming these obstacles. Objectives To identify educational interventions to enhance end-of-life care for nursing home staff and to identify types of study designs and outcomes to indicate success and benchmark interventions against recent international guidelines for education for palliative and end-of-life care. Design Thirteen databases and reference lists of key journals were searched from the inception of each up to September 2014. Included studies were appraised for quality and data were synthesised thematically. Results Twenty-one studies were reviewed. Methodological quality was poor. Education was not of a standard that could be expected to alter clinical behaviour and was evaluated mainly from the perspectives of staff: self-reported increase in knowledge, skills and confidence delivering care rather than direct evidence of impact on clinical practice and patient outcomes. Follow-up was often short term, and despite sound economic arguments for delivering effective end-of-life care to reduce burden on the health service, no economic analyses were reported. Conclusions There is a clear and urgent need to design educational interventions that have the potential to improve end-of-life care in nursing homes. Robust evaluation of these interventions should include impact on residents, families and staff and include economic analysis. PMID:27329513

  6. Education and training to enhance end-of-life care for nursing home staff: a systematic literature review.

    PubMed

    Anstey, Sally; Powell, Tom; Coles, Bernadette; Hale, Rachel; Gould, Dinah

    2016-09-01

    The delivery of end-of-life care in nursing homes is challenging. This situation is of concern as 20% of the population die in this setting. Commonly reported reasons include limited access to medical care, inadequate clinical leadership and poor communication between nursing home and medical staff. Education for nursing home staff is suggested as the most important way of overcoming these obstacles. To identify educational interventions to enhance end-of-life care for nursing home staff and to identify types of study designs and outcomes to indicate success and benchmark interventions against recent international guidelines for education for palliative and end-of-life care. Thirteen databases and reference lists of key journals were searched from the inception of each up to September 2014. Included studies were appraised for quality and data were synthesised thematically. Twenty-one studies were reviewed. Methodological quality was poor. Education was not of a standard that could be expected to alter clinical behaviour and was evaluated mainly from the perspectives of staff: self-reported increase in knowledge, skills and confidence delivering care rather than direct evidence of impact on clinical practice and patient outcomes. Follow-up was often short term, and despite sound economic arguments for delivering effective end-of-life care to reduce burden on the health service, no economic analyses were reported. There is a clear and urgent need to design educational interventions that have the potential to improve end-of-life care in nursing homes. Robust evaluation of these interventions should include impact on residents, families and staff and include economic analysis. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  7. Doctors, drugs, and the FDA.

    PubMed

    Shanklin, D R

    1972-11-01

    This communication is directed to obstetricians, to the Food and Drug Administration (FDA), and to those individuals who might want to impose possibly unnecessary external structures on the practice of medicine. It is considered a positive that the patients of today are well informed and are more actively participating in therapeutic design. There is more veto power on the part of the patient and more concern over the trained ability of the physician. In the past physicians frequently made judgements individually, applying isolated and at times random standards for their decisions. Such actions were inevitable in an era when neither pathogenesis nor treatment was well understood. Now there is no excuse for such actions. Communication is easy, journals are widely circulated, and there are numerous refresher seminars. Increased specialization of knowledge has meant more corporate or group decisions for therapy. Current trends will continue to offer both opportunities and responsibilities. The opportunities are for better diffusion of knowledge, and the responsibility is to be informed. There can be a high level national standard for medical practice. As a beginning, the medical practice laws could use some uniform decisions. The FDA needs to show more responsiveness to changing knowledge and increased willingness to reconsider indications and contraindications in the light of newer experience. There is sufficient information available now to support the revocation of the approval of the use of diuretics in the management of human pregnancy. Another role of the FDA is the approval of new substances or new uses of old substances. The prostaglandins appear in this category, and the December 1972 issue will include the recent Brook Lodge Symposium on prostaglandins. The individual physician requires journal articles, individual experience, and designed trials in order to make judgements on patients who may have some factors not accounted for by groupthink or regulations.

  8. FDA/CVM's Compliance Policy Guide on compounding of drugs.

    PubMed

    1996-12-15

    As a veterinary practitioner, do you combine drug agents for anesthesia? Create antidotes? Dilute liquids for administration to small, young, or exotic species? Such efforts are examples of compounding. The FDA/CVM's new Compliance Policy Guide (CPG), which regulates the compounding of drugs by veterinarians and pharmacists for use in animals appears here, as originally published in the Compliance Policy Guide Manual. The CPG provides guidance to FDA's field and headquarters staff and serves as a source of useful information to veterinarians. The CPG for Compounding of Drugs for Use in Animals reflects the efforts of a task force made up of a diverse group of veterinarians, pharmacists, and regulators whose conclusions were published in the Symposium of Compounding in JAVMA, July 15, 1994, pp 189-303.

  9. Motivating Staff.

    ERIC Educational Resources Information Center

    Tager, Shelley

    2002-01-01

    Camp directors can motivate staff by showing they are valued. Acknowledging positive actions, throwing a staff party, providing relief time, and being a good role model are all good motivators. Weekly staff meetings keep staff informed and provide time to air problems and get feedback. Keeping in touch with staff during the off-season is also…

  10. Bench-to-bedside review: Dealing with increased intensive care unit staff turnover: a leadership challenge

    PubMed Central

    Laporta, Denny P; Burns, Judy; Doig, Chip J

    2005-01-01

    Critical care leaders frequently must face challenging situations requiring specific leadership and management skills for which they are, not uncommonly, poorly prepared. Such a fictitious scenario was discussed at a Canadian interdisciplinary critical care leadership meeting, whereby increasing intensive care unit (ICU) staff turnover had led to problems with staff recruitment. Participants discussed and proposed solutions to the scenario in a structured format. The results of the discussion are presented. In situations such as this, the ICU leader should first define the core problem, its complexity, its duration and its potential for reversibility. These factors often reside within workload and staff support issues. Some examples of core problems discussed that are frequently associated with poor retention and recruitment are a lack of a positive team culture, a lack of a favorable ICU image, a lack of good working relationships between staff and disciplines, and a lack of specific supportive resources. Several tools or individuals (typically outside the ICU environment) are available to help determine the core problem. Once the core problem is identified, specific solutions can be developed. Such solutions often require originality and flexibility, and must be planned, with specific short-term, medium-term and long-term goals. The ICU leader will need to develop an implementation strategy for these solutions, in which partners who can assist are identified from within the ICU and from outside the ICU. It is important that the leader communicates to all stakeholders frequently as the process moves forward. PMID:16277732

  11. Alternate Forms of Graduate Education for Community College Staff: A Descriptive Review.

    ERIC Educational Resources Information Center

    O'Banion, Terry

    This paper describes the major types of university graduate programs now underway for the professional education of community college administrators, counselors, and instructors. On the basis of the implications of these existing programs, he makes nine recommendations to graduate schools considering new programs for community college staff. These…

  12. Staff Variables that Influence Responses to Challenging Behaviour of Clients with an Intellectual Disability: A Review

    ERIC Educational Resources Information Center

    Lambrechts, Greet; Petry, Katja; Maes, Bea

    2008-01-01

    This study gives a systematic and recent overview of studies that focus on staff variables that may have an influence on the origin and maintenance of challenging behaviour of clients with an intellectual disability. Thirty three studies were identified through computerized searches of the PsycInfo and ERIC-databases on the basis of specific…

  13. Review of Corneal Endothelial Specular Microscopy for FDA Clinical Trials of Refractive Procedures, Surgical Devices and New Intraocular Drugs and Solutions

    PubMed Central

    McCarey, Bernard E.; Edelhauser, Henry F.; Lynn, Michael J.

    2010-01-01

    Specular microscopy can provide a non-invasive morphological analysis of the corneal endothelial cell layer from subjects enrolled in clinical trials. The analysis provides a measure of the endothelial cell physiological reserve from aging, ocular surgical procedures, pharmaceutical exposure, and general health of the corneal endothelium. The purpose of this review is to discuss normal and stressed endothelial cell morphology, the techniques for determining the morphology parameters, and clinical trial applications. PMID:18245960

  14. Impact of the design of neonatal intensive care units on neonates, staff, and families: a systematic literature review.

    PubMed

    Shahheidari, Marzieh; Homer, Caroline

    2012-01-01

    Newborn intensive care is for critically ill newborns requiring constant and continuous care and supervision. The survival rates of critically ill infants and hospitalization in neonatal intensive care units (NICUs) have improved over the past 2 decades because of technological advances in neonatology. The design of NICUs may also have implications for the health of babies, parents, and staff. It is important therefore to articulate the design features of NICU that are associated with improved outcomes. The aim of this study was to explore the main features of the NICU design and to determine the advantages and limitations of the designs in terms of outcomes for babies, parents, and staff, predominately nurses. A systematic review of English-language, peer-reviewed articles was conducted for a period of 10 years, up to January 2011. Four online library databases and a number of relevant professional Web sites were searched using key words. There were 2 main designs of NICUs: open bay and single-family room. The open-bay environment develops communication and interaction with medical staff and nurses and has the ability to monitor multiple infants simultaneously. The single-family rooms were deemed superior for patient care and parent satisfaction. Key factors associated with improved outcomes included increased privacy, increased parental involvement in patient care, assistance with infection control, noise control, improved sleep, decreased length of hospital stay, and reduced rehospitalization. The design of NICUs has implications for babies, parents, and staff. An understanding of the positive design features needs to be considered by health service planners, managers, and those who design such specialized units.

  15. FDA Approvals of Brand-Name Prescription Drugs in 2015

    PubMed Central

    2016-01-01

    The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories: New Pharmaceuticals: New Molecular Entities and New Biologic License ApplicationsNew Combinations and New IndicationsNew Dosage Forms and New FormulationsNew Biosimilars, Vaccines, Viral Therapies, and Blood Products PMID:27668042

  16. FDA Approvals of Brand-Name Prescription Drugs in 2015.

    PubMed

    2016-03-01

    The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories: New Pharmaceuticals: New Molecular Entities and New Biologic License ApplicationsNew Combinations and New IndicationsNew Dosage Forms and New FormulationsNew Biosimilars, Vaccines, Viral Therapies, and Blood Products.

  17. Overview of FDA's Expanded Access Program for Investigational Drugs.

    PubMed

    Jarow, Jonathan P; Lurie, Peter; Ikenberry, Sarah Crowley; Lemery, Steven

    2017-03-01

    Expanded access, also called "compassionate use," provides a pathway for patients to gain access to investigational drugs, biologics, and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions for which there are no comparable or satisfactory therapy options available outside of clinical trials. The US Food and Drug Administration (FDA) facilitates the expanded access process; however, access to investigational treatments requires not only FDA's review and authorization but also the active involvement and cooperation of other parties, including drug companies and health care providers, in order to be successful.

  18. US FDA perspective on regulatory issues affecting circulatory assist devices.

    PubMed

    Sapirstein, Wolf; Chen, Eric; Swain, Julie; Zuckerman, Bram

    2006-11-01

    There has been a rapid development in mechanical circulatory support systems in the decade since the US FDA first approved a mechanical device to provide the circulatory support lacking from a failing heart. Devices are presently approved for marketing by the FDA to replace a failing ventricle, the Ventricular Assist Device or the entire heart, Total Artificial Heart. Contemporaneous with, and permitted by, improvement in technology and design, devices have evolved from units located extracorporeally to paracorporeal systems and totally implanted devices. Clinical studies have demonstrated a parallel improvement in the homeostatic adequacy of the circulatory support provided. Thus, while the circulatory support was initially tolerated for short periods to permit recovery of cardiac function, this technology eventually provided effective circulatory support for increasing periods that permitted the FDA to approve devices for bridging patients in end-stage cardiac failure awaiting transplant and eventually a device for destination therapy where patients in end-stage heart failure are not cardiac transplant candidates. The approved devices have relied on displacement pumps that mimic the pulsatility of the physiological system. Accelerated development of more compact devices that rely on alternative pump mechanisms have challenged both the FDA and device manufacturers to assure that the regulatory requirements for safety and effectiveness are met for use of mechanical circulatory support systems in expanded target populations. An FDA regulatory perspective is reviewed of what can be a potentially critical healthcare issue.

  19. Drug development in inflammatory bowel disease: the role of the FDA.

    PubMed

    Lahiff, Conor; Kane, Sunanda; Moss, Alan C

    2011-12-01

    All medicinal compounds sold in the United States for inflammatory bowel disease (IBD) are regulated by the Food and Drug Administration (FDA) via a number of regulations dating back to 1906. The primary contemporary role of the FDA is in the assessment of safety and efficacy, and subsequent marketing, of medications based on preclinical and clinical trial data provided by sponsors. This includes pharmacokinetic, toxicology and clinical studies, and postapproval safety monitoring. Mesalamine formulations, budesonide, and biologic therapies have all been assessed for efficacy and safety in IBD by the FDA via large randomized controlled trials (RCTs). There has been considerable evolution in the endpoints used by the FDA to approve medications for IBD, and the mechanisms through which newer agents have been approved. This review examines the methods of drug approval by the FDA, the bench-marks used to approve drugs for IBD, and recent controversies in the FDA's role in drug approval in general.

  20. FDA reform signed into law. Food and Drug Administration.

    PubMed

    James, J S

    1997-12-05

    The laws under which the Food and Drug Administration (FDA) operates have been changed by bipartisan Congressional efforts. The FDA Modernization Act of 1997, signed into law on November 21, 1997 modifies the mission of the FDA to include a goal of speeding research, innovation and access to care. The legislation allows fast track review for the most important drugs. It also allows drug companies to promote off label use of already-approved pharmaceuticals for other purposes. The controversial issue allows drug companies to provide physicians with documentation on the effectiveness of their drugs in treating other conditions. The industry supports the change since the revenue growth for off label use of drugs is especially important for smaller biotechnical companies, while consumer groups fear that it is a loophole for selling unproven drugs. The bill also renews the Prescription Drug User Fee Act (PDUFA), regulating the current practice of compounding, and monitoring medical devices and health care claims for foods.

  1. Web-based training related to NRC staff review of dose modeling aspects of license termination and decommissioning plans.

    SciTech Connect

    LePoire, D.; Arnish, J.; Cheng, J. J.; Kamboj, S.; Richmond, P.; Chen, S. Y.; Barr, C.; McKenney, C.; Environmental Science Division; NRC

    2007-01-01

    NRC licensees at decommissioning nuclear facilities submit License Termination Plans (LTP) or Decommissioning Plans (DP) to NRC for review and approval. To facilitate a uniform and consistent review of these plans, the NRC developed training for its staff. A live classroom course was first developed in 2005, which targeted specific aspects of the LTP and DP review process related to dose-based compliance demonstrations or modeling. A web-based training (WBT) course is being developed in 2006 to replace the classroom-based course. The advantage of the WBT is that it will allow for staff training or refreshers at any time, while the advantage of a classroom-based course is that it provides a forum for lively discussion and the sharing of experience of classroom participants. The training course consists of the core and advanced modules tailored to specific NRC job functions. Topics for individual modules include identifying the characteristics of simple and complex sites, identifying when outside expertise or consultation is needed, demonstrating how to conduct acceptance and technical reviews of dose modeling, and providing details regarding the level of justification needed for realistic scenarios for both dose modeling and derivation of DCGLs. Various methods of applying probabilistic uncertainty analysis to demonstrate compliance with dose-based requirements are presented. These approaches include: (1) modeling the pathways of radiological exposure and estimating doses to receptors from a combination of contaminated media and radionuclides, and (2) using probabilistic analysis to determine an appropriate set of input parameters to develop derived concentration guideline limits or DCGLs (DCGLs are media- and nuclide-specific concentration limits that will meet dose-based, license termination rule criteria found in 10 CFR Part 20, Subpart E). Calculation of operational (field) DCGL's from media- and nuclide-specific DCGLs and use of operational DCGLs in conducting

  2. Web-based training related to NRC staff review of dose modeling aspects of license termination and decommissioning plans

    SciTech Connect

    LePoire, D.; Arnish, J.; Cheng, J.J.; Kamboj, S.; Richmond, P.; Chen, S.Y.; Barr, C.; McKenney, C.

    2007-07-01

    NRC licensees at decommissioning nuclear facilities submit License Termination Plans (LTP) or Decommissioning Plans (DP) to NRC for review and approval. To facilitate a uniform and consistent review of these plans, the NRC developed training for its staff. A live classroom course was first developed in 2005, which targeted specific aspects of the LTP and DP review process related to dose-based compliance demonstrations or modeling. A web-based training (WBT) course is being developed in 2006 to replace the classroom-based course. The advantage of the WBT is that it will allow for staff training or refreshers at any time, while the advantage of a classroom-based course is that it provides a forum for lively discussion and the sharing of experience of classroom participants. The training course consists of the core and advanced modules tailored to specific NRC job functions. Topics for individual modules include identifying the characteristics of simple and complex sites, identifying when outside expertise or consultation is needed, demonstrating how to conduct acceptance and technical reviews of dose modeling, and providing details regarding the level of justification needed for realistic scenarios for both dose modeling and derivation of DCGLs. Various methods of applying probabilistic uncertainty analysis to demonstrate compliance with dose-based requirements are presented. These approaches include 1) modeling the pathways of radiological exposure and estimating doses to receptors from a combination of contaminated media and radionuclides, and 2) using probabilistic analysis to determine an appropriate set of input parameters to develop derived concentration guideline limits or DCGLs (DCGLs are media- and nuclide-specific concentration limits that will meet dose-based, license termination rule criteria found in 10 CFR Part 20, Subpart E). Calculation of operational (field) DCGL's from media- and nuclide-specific DCGLs and use of operational DCGLs in conducting

  3. 19 CFR 207.64 - Staff reports.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... EXPORTS TO THE UNITED STATES Five-Year Reviews § 207.64 Staff reports. (a) Prehearing staff report. The... information concerning the subject matter of the five-year review. A version of the staff report containing...

  4. Nursing Staff Members Mental’s Health and Factors Associated with the Work Process: An Integrative Review

    PubMed Central

    Vasconcelos, Selene Cordeiro; Lopes de Souza, Sandra; Botelho Sougey, Everton; de Oliveira Ribeiro, Elayne Cristina; Costa do Nascimento, José Jailson; Formiga, Mariana Bandeira; Batista de Souza Ventura, Luciana; Duarte da Costa Lima, Murilo; Silva, Antonia Oliveira

    2016-01-01

    Background: The mental health of nursing staff members influences the work process outcomes. Objective: Identify the work related factors that harms the nursing team’s mental health. Methods: Databases PubMed, Scopus, CINAHL and MEDLINE, by mating between the indexed descriptors in MeSH terms “mental health” and “occupational health nursing”. 783 articles were rescued to give a final sample of 18 articles. Integrative review in order to identify factors associated with the work process of the nursing staff that negatively affects mental health. Results: The main associated factors were work demands, psychological demands, violence, aggression, poor relationships with administrators, accidents involving the risk of exposure to HIV, stress and errors in the execution of labor activities. The main findings regarding the nursing staff’s mental health were post-traumatic stress disorder, depression, stress, major depressive episode and generalized anxiety disorder. Conclusion: Occupational nurses need to understand the complexities of mental health problems and substance use among nursing staff members to recognize, identify and care for workers at risk and offer adequate mental health care. Although the researches interests in this theme have increased, proving that all these factors contribute to the risk to mental health of nursing professionals, the protective measures and care are being neglected by managers in both private and public network . The health of nursing workers in question here is one more challenge for a profession that takes care of others in need, therefore, requires some caring with their own health. PMID:28217144

  5. FDA review summary: Mozobil in combination with granulocyte colony-stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation.

    PubMed

    Brave, Michael; Farrell, Ann; Ching Lin, Sue; Ocheltree, Terrance; Pope Miksinski, Sarah; Lee, Shwu-Luan; Saber, Haleh; Fourie, Jeanne; Tornoe, Christoffer; Booth, Brian; Yuan, Weishi; He, Kun; Justice, Robert; Pazdur, Richard

    2010-01-01

    On December 15, 2008, the US Food and Drug Administration approved plerixafor (Mozobil; Genzyme Corp.), a new small-molecule inhibitor of the CXCR4 chemokine receptor, for use in combination with granulocyte colony-stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSC) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM). This summary reviews the database supporting this approval. The safety and efficacy of plerixafor were demonstrated by 2 multicenter, randomized, placebo-controlled studies in patients with NHL and MM who were eligible for autologous HSC transplantation. The primary efficacy end points were the collection of > or = 5 x 10(6) CD34+ cells/kg from the peripheral blood in 4 or fewer apheresis sessions in patients with NHL or > or = 6 x 10(6) CD34+ cells/kg from the peripheral blood in 2 or fewer apheresis sessions in patients with MM. The 2 randomized studies combined enrolled 600 patients (298 with NHL and 302 with MM). Fifty-nine percent of patients with NHL who were mobilized with G-CSF and plerixafor had peripheral blood HSC collections of > or = 5 x 10(6) CD34+ cells/kg in 4 or fewer apheresis sessions, compared with 20% of patients with NHL who were mobilized with G-CSF and placebo (p < 0.001). Seventy-two percent of patients with MM who were mobilized with Mozobil and G-CSF had peripheral blood HSC collections of > or = 6 x 10(6) CD34+ cells/kg in 2 or fewer apheresis sessions, compared with 34% of patients with MM who were mobilized with placebo and G-CSF (p < 0.001). Common adverse reactions included diarrhea, nausea, vomiting, flatulence, injection site reactions, fatigue, arthralgia, headache, dizziness, and insomnia. This report describes the Food and Drug Administration review supporting the approval of plerixafor. Copyright 2010 S. Karger AG, Basel.

  6. The Role of Expressed Emotion in Relationships Between Psychiatric Staff and People With a Diagnosis of Psychosis: A Review of the Literature

    PubMed Central

    Berry, Katherine; Barrowclough, Christine; Haddock, Gillian

    2011-01-01

    The concept of expressed emotion (EE) has been extended to the study of staff-patient relationships in schizophrenia. A comprehensive review of the literature identified a total of 27 studies investigating EE in this group published between 1990 and 2008. The article aims to assess whether the concept of EE is a useful and valid measure of the quality of professional caregiver and patient relationships, given that staff may be less emotionally invested in relationships than relatives. In doing so, it summarizes methods of measuring EE, the nature of professional EE compared with familial EE, associations between high EE and patient outcomes, associations between EE and both patient and staff variables, and intervention studies to reduce staff high EE. The available evidence suggests that the Camberwell Family Interview is an acceptable measure of EE in staff-patient relationships, although the Five Minute Speech Sample may provide a less resource intensive alternative. However, in contrast to familial research, neither the EE status on the Camberwell Family Interview nor the Five Minute Speech Sample show a robust relationship with outcomes. The presence or absence of a positive staff-patient relationship may have more predictive validity in this group. There is relatively consistent evidence of associations between staff criticism and poorer patient social functioning. Consistent with findings in familial research, staff attributions may play a key role in driving critical responses, and it may be possible to reduce staff high EE by modifying negative appraisals. PMID:20056685

  7. Hypnotic Medications and Suicide: Risk, Mechanisms, Mitigation, and the FDA.

    PubMed

    McCall, W Vaughn; Benca, Ruth M; Rosenquist, Peter B; Riley, Mary Anne; McCloud, Laryssa; Newman, Jill C; Case, Doug; Rumble, Meredith; Krystal, Andrew D

    2017-01-01

    Insomnia is associated with increased risk for suicide. The Food and Drug Administration (FDA) has mandated that warnings regarding suicide be included in the prescribing information for hypnotic medications. The authors conducted a review of the evidence for and against the claim that hypnotics increase the risk of suicide. This review focused on modern, FDA-approved hypnotics, beginning with the introduction of benzodiazepines, limiting its findings to adults. PubMed and Web of Science were searched, crossing the terms "suicide" and "suicidal" with each of the modern FDA-approved hypnotics. The FDA web site was searched for postmarketing safety reviews, and the FDA was contacted with requests to provide detailed case reports for hypnotic-related suicide deaths reported through its Adverse Event Reporting System. Epidemiological studies show that hypnotics are associated with an increased risk for suicide. However, none of these studies adequately controlled for depression or other psychiatric disorders that may be linked with insomnia. Suicide deaths have been reported from single-agent hypnotic overdoses. A separate concern is that benzodiazepine receptor agonist hypnotics can cause parasomnias, which in rare cases may lead to suicidal ideation or suicidal behavior in persons who were not known to be suicidal. On the other hand, ongoing research is testing whether treatment of insomnia may reduce suicidality in adults with depression. The review findings indicate that hypnotic medications are associated with suicidal ideation. Future studies should be designed to assess whether increases in suicidality result from CNS impairments from a given hypnotic medication or whether such medication decreases suicidality because of improvements in insomnia.

  8. FDA Issues Final Guidance Clarifying FDA and EPA Jurisdiction over Mosquito-Related Products

    EPA Pesticide Factsheets

    FDA finalized guidance to provide information on FDA and EPA jurisdiction over the regulation of mosquito-related products intended to function as pesticides, including those products intended to function as pesticides

  9. A review of the regulatory and functional aspects of prison health care and nursing staff.

    PubMed

    Arribas-López, E

    2015-01-01

    The aim of this study of prison health care staff in Prison Health Care and Nursing Units is twofold. The first one is to consider those aspects of the legal system applicable to them as government employees of the General State Administration at the service of Prisons, highlighting the peculiarities of the legal regulations that can be applied as a result of providing said service. The second, based on the general regulations on prison health contained in Organic Law 1/1979, of 26 September, General Penitentiary Law and the implementing regulations thereof, approved by Royal Decree 190/1966, of 9 February, sets out to provide a critical analysis of the obligatory and functional framework for health care and nursing staff established in the old Penitentiary Regulations of 1981, to determine from a legal perspective if it is possible to impede or brake so that the Prison Administration may develop or carry out the functions for which it is responsible in terms of planning, organization and management of activities geared towards maintaining and improving hygiene and health in the prison environment.

  10. Access to F.D.A. Information.

    ERIC Educational Resources Information Center

    Sinovic, Dianna

    Prior to the enactment of the Freedom of Information Act (FOIA), little of the data collected by the Food and Drug Administration (FDA) was made public or could be obtained from the agency. Although the FDA files are now open, information is considered exempt from public disclosure when it involves regulatory procedures, program guidelines, work…

  11. The new FDA combination products programme.

    PubMed

    Donawa, Maria

    2002-10-01

    The United States (US) Food and Drug Administration (FDA) has established a Combination Products Programme and developed a new internal procedure to increase its effectiveness in regulating products consisting of combinations of drugs, devices and biological products. This article provides a brief overview of the FDA regulation of combination products and discusses the new Programme.

  12. FDA final guidance on software validation.

    PubMed

    Donawa, Maria

    2002-04-01

    The United States Food and Drug Administration (FDA) places considerable importance on the validation of software contained in and used to design, develop, or manufacture medical devices. This article discusses a recently published final FDA guidance document on software validation and the reasons for its importance.

  13. Access to F.D.A. Information.

    ERIC Educational Resources Information Center

    Sinovic, Dianna

    Prior to the enactment of the Freedom of Information Act (FOIA), little of the data collected by the Food and Drug Administration (FDA) was made public or could be obtained from the agency. Although the FDA files are now open, information is considered exempt from public disclosure when it involves regulatory procedures, program guidelines, work…

  14. FDA regulation of invasive neural recording electrodes: a daunting task for medical innovators.

    PubMed

    Welle, Cristin; Krauthamer, Victor

    2012-03-01

    The U.S. Food and Drug Administration (FDA) is charged with assuring the safety and effectiveness of medical devices. Before any medical device can be brought to market, it must comply with all federal regulations regarding FDA processes for clearance or approval. Navigating the FDA regulatory process may seem like a daunting task to the innovator of a novel medical device who has little experience with the FDA regulatory process or device commercialization. This review introduces the basics of the FDA regulatory premarket process, with a focus on issues relating to chronically implanted recording devices in the central or peripheral nervous system. Topics of device classification and regulatory pathways, the use of standards and guidance documents, and optimal time lines for interaction with the FDA are discussed. Additionally, this article summarizes the regulatory research on neural implant safety and reliability conducted by the FDA's Office of Science and Engineering Laboratories (OSEL) in collaboration with Defense Advanced Research Projects Agency (DARPA) Reliable Neural Technology (RE-NET) Program. For a more detailed explanation of the medical device regulatory process, please refer to several excellent reviews of the FDA's regulatory pathways for medical devices [1]-[4].

  15. A systematic review of clinician and staff views on the acceptability of incorporating remote monitoring technology into primary care.

    PubMed

    Davis, Melinda M; Freeman, Michele; Kaye, Jeffrey; Vuckovic, Nancy; Buckley, David I

    2014-05-01

    Remote monitoring technology (RMT) may enhance healthcare quality and reduce costs. RMT adoption depends on perceptions of the end-user (e.g., patients, caregivers, healthcare providers). We conducted a systematic review exploring the acceptability and feasibility of RMT use in routine adult patient care, from the perspectives of primary care clinicians, administrators, and clinic staff. We searched the databases of Medline, IEEE Xplore, and Compendex for original articles published from January 1996 through February 2013. We manually screened bibliographies of pertinent studies and consulted experts to identify English-language studies meeting our inclusion criteria. Of 939 citations identified, 15 studies reported in 16 publications met inclusion criteria. Studies were heterogeneous by country, type of RMT used, patient and provider characteristics, and method of implementation and evaluation. Clinicians, staff, and administrators generally held positive views about RMTs. Concerns emerged regarding clinical relevance of RMT data, changing clinical roles and patterns of care (e.g., reduced quality of care from fewer patient visits, overtreatment), insufficient staffing or time to monitor and discuss RMT data, data incompatibility with a clinic's electronic health record (EHR), and unclear legal liability regarding response protocols. This small body of heterogeneous literature suggests that for RMTs to be adopted in primary care, researchers and developers must ensure clinical relevance, support adequate infrastructure, streamline data transmission into EHR systems, attend to changing care patterns and professional roles, and clarify response protocols. There is a critical need to engage end-users in the development and implementation of RMT.

  16. [Evaluation and intervention of psychological work climate among nursing staff : a review of the literature].

    PubMed

    Maillet, Stéphanie; Courcy, François; Leblanc, Jeannette

    2016-07-01

    This review of literature focuses on the influence of psychological work climate and job satisfaction on nurses’ turnover intentions. More specifically, this review aims to explain the influence of the primary dimensions of psychological work climate - job characteristics, role characteristics, leadership characteristics, teamwork characteristics and organizational characteristics - on nurses’ organizational and occupational turnover intentions. Furthermore, this review aims to explain the role of job satisfaction as a potential mediator in the relationship between psychological work climate dimensions and both organizational and occupational turnover intentions among nurses. More specifically, the mechanism by which an individual goes from having negative perceptions of psychological work climate to having turnover intentions is introduced. The review concludes by revealing evaluation and intervention practices that may facilitate the implementation of continuous improvement processes aimed to enhance nurses’ perceptions of the psychological work climate and job satisfaction.

  17. 76 FR 27387 - Agency Information Collection Activity (Lenders Staff Appraisal Reviewer (SAR) Application) Under...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-11

    ....Regulations.gov or to VA's OMB Desk Officer, OMB Human Resources and Housing Branch, New Executive Office... approved, SARs will have the authority to review real estate appraisals and to issue notices of values on...

  18. Education and training of healthcare staff in the knowledge, attitudes and skills needed to work effectively with breastfeeding women: a systematic review.

    PubMed

    Gavine, Anna; MacGillivray, Steve; Renfrew, Mary J; Siebelt, Lindsay; Haggi, Haggi; McFadden, Alison

    2016-01-01

    Current evidence suggests that women need effective support to breastfeed, but many healthcare staff lack the necessary knowledge, attitudes and skills. There is therefore a need for breastfeeding education and training for healthcare staff. The primary aim of this review is to determine whether education and training programs for healthcare staff have an effect on their knowledge and attitudes about supporting breastfeeding women. The secondary aim of this review was to identify whether any differences in type of training or discipline of staff mattered. A systematic search of the literature was conducted using the Cochrane Pregnancy and Childbirth Group's trial register. Randomised controlled trials comparing breastfeeding education and training for healthcare staff with no or usual training and education were included if they measured the impact on staff knowledge, attitudes or compliance with the Baby Friendly Hospital Initiative (BFHI). From the 1192 reports identified, four distinct studies were included. Three studies were two-arm cluster-randomised trials and one was a two-arm individual randomised trial. Of these, three contributed quantitative data from a total of 250 participants. Due to heterogeneity of outcome measures meta-analysis was not possible. Knowledge was included as an outcome in two studies and demonstrated small but significant positive effects. Attitudes towards breastfeeding was included as an outcome in two studies, however, results were inconsistent both in terms of how they were measured and the intervention effects. One study reported a small but significant positive effect on BFHI compliance. Study quality was generally deemed low with the majority of domains being judged as high or unclear risk of bias. This review identified a lack of good evidence on breastfeeding education and training for healthcare staff. There is therefore a critical need for research to address breastfeeding education and training needs of multidisciplinary

  19. FDA Approval Summary: TAS-102.

    PubMed

    Marcus, Leigh; Lemery, Steven J; Khasar, Sachia; Wearne, Emily; Helms, Whitney S; Yuan, Weishi; He, Kun; Cao, Xianhua; Yu, Jingyu; Zhao, Hong; Wang, Yaning; Stephens, Olen; Englund, Erika; Agarwal, Rajiv; Keegan, Patricia; Pazdur, Richard

    2017-06-15

    The FDA approved TAS-102 (Lonsurf; Taiho Oncology, Inc.) for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; an anti-VEGF biological therapy; and if RAS wild type, an anti-EGFR therapy. In an international, multicenter, double-blinded, placebo-controlled trial (TPU-TAS-102-301, herein referred to as RECOURSE), 800 patients with previously treated mCRC were randomly allocated (2:1) to receive either TAS-102 35 mg/m(2) orally twice daily after meals on days 1 through 5 and 8 through 12 of each 28-day cycle (n = 534) or matching placebo (n = 266). The trial demonstrated a statistically significant improvement in overall survival for those randomized to receive TAS-102, with a median survival of 7.1 months in the TAS-102 arm [confidence interval (CI), 6.5-7.8] and 5.3 months in the placebo arm [CI, 4.6-6.0; hazard ratio (HR), 0.68; 95% CI, 0.58-0.81; P < 0.001, stratified log-rank test]. The trial also demonstrated a statistically significant prolongation of progression-free survival (HR, 0.47; 95% CI, 0.40-0.55; P < 0.001). The most common adverse reactions, in order of decreasing frequency, observed in the patients who received TAS-102 were anemia, neutropenia, asthenia/fatigue, nausea, thrombocytopenia, decreased appetite, diarrhea, vomiting, abdominal pain, and pyrexia. Adverse events led to discontinuation of TAS-102 in 3.6% of patients, and 13.7% required a dose reduction. The most common adverse reactions leading to dose reduction were neutropenia, anemia, febrile neutropenia, fatigue, and diarrhea. Clin Cancer Res; 23(12); 2924-7. ©2017 AACR. ©2017 American Association for Cancer Research.

  20. Effects of person-centered care on residents and staff in aged-care facilities: a systematic review

    PubMed Central

    Brownie, Sonya; Nancarrow, Susan

    2013-01-01

    Background Several residential aged-care facilities have replaced the institutional model of care to one that accepts person-centered care as the guiding standard of practice. This culture change is impacting the provision of aged-care services around the world. This systematic review evaluates the evidence for an impact of person-centered interventions on aged-care residents and nursing staff. Methods We searched Medline, Cinahl, Academic Search Premier, Scopus, Proquest, and Expanded Academic ASAP databases for studies published between January 1995 and October 2012, using subject headings and free-text search terms (in UK and US English spelling) including person-centered care, patient-centered care, resident-oriented care, Eden Alternative, Green House model, Wellspring model, long-term care, and nursing homes. Results The search identified 323 potentially relevant articles. Once duplicates were removed, 146 were screened for inclusion in this review; 21 were assessed for methodological quality, resulting in nine articles (seven studies) that met our inclusion criteria. There was only one randomized, controlled trial. The majority of studies were quasi-experimental pre-post test designs, with a control group (n = 4). The studies in this review incorporated a range of different outcome measures (ie, dependent variables) to evaluate the impact of person-centered interventions on aged-care residents and staff. One person-centered intervention, ie, the Eden Alternative, was associated with significant improvements in residents’ levels of boredom and helplessness. In contrast, facility-specific person-centered interventions were found to impact nurses’ sense of job satisfaction and their capacity to meet the individual needs of residents in a positive way. Two studies found that person-centered care was actually associated with an increased risk of falls. The findings from this review need to be interpreted cautiously due to limitations in study designs and the

  1. Education of staff in preschool aged classrooms in child care centers and child outcomes: A meta-analysis and systematic review.

    PubMed

    Falenchuk, Olesya; Perlman, Michal; McMullen, Evelyn; Fletcher, Brooke; Shah, Prakesh S

    2017-01-01

    Staff education is considered key to quality of early childhood education and care (ECEC) programs. However, findings about associations between staff education and children's outcomes have been inconsistent. We conducted a systematic review and meta-analysis of associations between ECEC staff education and child outcomes. Searches of Medline, PsycINFO, and ERIC, websites of large datasets and reference sections of all retrieved articles were conducted. Eligible studies provided a statistical link between staff education and child outcomes for preschool-aged children in ECEC programs. Titles, abstracts and paper reviews as well as all data extraction were conducted by two independent raters. Of the 823 studies reviewed for eligibility, 39 met our inclusion criteria. Research in this area is observational in nature and subject to the inherent biases of that research design. Results from our systematic review were hampered by heterogeneity in how staff education was defined, variability in whose education was measured and the child outcomes that were assessed. However, overall the qualitative summary indicates that associations between staff education and childhood outcomes are non-existent to very borderline positive. In our meta-analysis of more homogeneous studies we identified certain positive, albeit very weak, associations between staff education and children's language outcomes (specifically, vocabulary and letter word identification) and no significant association with a mathematics outcome (WJ Applied Problems). Thus, our findings suggest that within the range of education levels found in the existing literature, education is not a key driver of child outcomes. However, since we only explored levels of education that were reported in the literature, our findings cannot be used to argue for lowering education standards in ECEC settings.

  2. Education of staff in preschool aged classrooms in child care centers and child outcomes: A meta-analysis and systematic review

    PubMed Central

    Falenchuk, Olesya; Perlman, Michal; McMullen, Evelyn; Fletcher, Brooke; Shah, Prakesh S.

    2017-01-01

    Staff education is considered key to quality of early childhood education and care (ECEC) programs. However, findings about associations between staff education and children’s outcomes have been inconsistent. We conducted a systematic review and meta-analysis of associations between ECEC staff education and child outcomes. Searches of Medline, PsycINFO, and ERIC, websites of large datasets and reference sections of all retrieved articles were conducted. Eligible studies provided a statistical link between staff education and child outcomes for preschool-aged children in ECEC programs. Titles, abstracts and paper reviews as well as all data extraction were conducted by two independent raters. Of the 823 studies reviewed for eligibility, 39 met our inclusion criteria. Research in this area is observational in nature and subject to the inherent biases of that research design. Results from our systematic review were hampered by heterogeneity in how staff education was defined, variability in whose education was measured and the child outcomes that were assessed. However, overall the qualitative summary indicates that associations between staff education and childhood outcomes are non-existent to very borderline positive. In our meta-analysis of more homogeneous studies we identified certain positive, albeit very weak, associations between staff education and children’s language outcomes (specifically, vocabulary and letter word identification) and no significant association with a mathematics outcome (WJ Applied Problems). Thus, our findings suggest that within the range of education levels found in the existing literature, education is not a key driver of child outcomes. However, since we only explored levels of education that were reported in the literature, our findings cannot be used to argue for lowering education standards in ECEC settings. PMID:28854281

  3. Child-Staff Ratios in Early Childhood Education and Care Settings and Child Outcomes: A Systematic Review and Meta-Analysis

    PubMed Central

    Perlman, Michal; Fletcher, Brooke; Falenchuk, Olesya; Brunsek, Ashley; McMullen, Evelyn; Shah, Prakesh S.

    2017-01-01

    Child-staff ratios are a key quality indicator in early childhood education and care (ECEC) programs. Better ratios are believed to improve child outcomes by increasing opportunities for individual interactions and educational instruction from staff. The purpose of this systematic review, and where possible, meta-analysis, was to evaluate the association between child-staff ratios in preschool ECEC programs and children’s outcomes. Searches of Medline, PsycINFO, ERIC, websites of large datasets and reference sections of all retrieved articles were conducted up to July 3, 2015. Cross-sectional or longitudinal studies that evaluated the relationship between child-staff ratios in ECEC classrooms serving preschool aged children and child outcomes were independently identified by two reviewers. Data were independently extracted from included studies by two raters and differences between raters were resolved by consensus. Searches revealed 29 eligible studies (31 samples). Child-staff ratios ranged from 5 to 14.5 preschool-aged children per adult with a mean of 8.65. All 29 studies were included in the systematic review. However, the only meta-analysis that could be conducted was based on three studies that explored associations between ratios and children’s receptive language. Results of this meta-analysis were not significant. Results of the qualitative systematic review revealed few significant relationships between child-staff ratios and child outcomes construed broadly. Thus, the available literature reveal few, if any, relationships between child-staff ratios in preschool ECEC programs and children’s developmental outcomes. Substantial heterogeneity in the assessment of ratios, outcomes measured, and statistics used to capture associations limited quantitative synthesis. Other methodological limitations of the research integrated in this synthesis are discussed. PMID:28103288

  4. Beyond biotechnology: FDA regulation of nanomedicine.

    PubMed

    Miller, John

    2003-01-01

    Nanotechnology, which involves investigating and manipulating matter at the atomic and molecular levels, may radically transform industry and society. Because nanotechnology could introduce whole new classes of materials and products, it could present an array of novel challenges to regulatory agencies. In this note, John Miller explores the regulatory challenges facing the Food and Drug Administration in regulating nanomedical products. First, the FDA will have trouble fitting the products into the agency's classification scheme. Second, it will be difficult for the FDA to maintain adequate scientific expertise in the field. He concludes that the FDA should consider implementing several reforms now to ensure that it is adequately prepared to regulate nanomedicine.

  5. 76 FR 9027 - Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-16

    ... Staff on Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using... industry and FDA staff entitled ``Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets.'' The draft guidance is intended to describe best...

  6. Improving Women's Occupational Potential. A Review of the Literature. Summary Staff Report.

    ERIC Educational Resources Information Center

    Wirtenberg, Jeana

    A review of literature on improving women's occupational potential was conducted. Most existing theories of occupational development focus on males. However, the beginnings of several theories of women's occupational development have recently been proposed. These are (1) structural theories, revolving around personality traits and ability patterns…

  7. New Eczema Drug Gets FDA's Blessing

    MedlinePlus

    ... page: https://medlineplus.gov/news/fullstory_164327.html New Eczema Drug Gets FDA's Blessing Injections may ease ... News) -- Adults plagued by eczema may have a new treatment option, with a new drug approved Tuesday ...

  8. FDA Approves First Immunotherapy for Lymphoma

    Cancer.gov

    The FDA has approved nivolumab (Opdivo®) for the treatment of patients with classical Hodgkin lymphoma whose disease has relapsed or worsened after receiving an autologous hematopoietic stem cell transplantation followed by brentuximab vedotin (Adcetris®)

  9. FDA Suggests Limits on Lead in Cosmetics

    MedlinePlus

    ... 162726.html FDA Suggests Limits on Lead in Cosmetics Agency notes most products already below recommended level ... limit on how much lead can be in cosmetics ranging from lipstick and eye shadow to blush ...

  10. A Systematic Review of Clinician and Staff Views on the Acceptability of Incorporating Remote Monitoring Technology into Primary Care

    PubMed Central

    Freeman, Michele; Kaye, Jeffrey; Vuckovic, Nancy; Buckley, David I.

    2014-01-01

    Abstract Objective: Remote monitoring technology (RMT) may enhance healthcare quality and reduce costs. RMT adoption depends on perceptions of the end-user (e.g., patients, caregivers, healthcare providers). We conducted a systematic review exploring the acceptability and feasibility of RMT use in routine adult patient care, from the perspectives of primary care clinicians, administrators, and clinic staff. Materials and Methods: We searched the databases of Medline, IEEE Xplore, and Compendex for original articles published from January 1996 through February 2013. We manually screened bibliographies of pertinent studies and consulted experts to identify English-language studies meeting our inclusion criteria. Results: Of 939 citations identified, 15 studies reported in 16 publications met inclusion criteria. Studies were heterogeneous by country, type of RMT used, patient and provider characteristics, and method of implementation and evaluation. Clinicians, staff, and administrators generally held positive views about RMTs. Concerns emerged regarding clinical relevance of RMT data, changing clinical roles and patterns of care (e.g., reduced quality of care from fewer patient visits, overtreatment), insufficient staffing or time to monitor and discuss RMT data, data incompatibility with a clinic's electronic health record (EHR), and unclear legal liability regarding response protocols. Conclusions: This small body of heterogeneous literature suggests that for RMTs to be adopted in primary care, researchers and developers must ensure clinical relevance, support adequate infrastructure, streamline data transmission into EHR systems, attend to changing care patterns and professional roles, and clarify response protocols. There is a critical need to engage end-users in the development and implementation of RMT. PMID:24731239

  11. Nursing home staff training in dementia care: a systematic review of evaluated programs.

    PubMed

    Kuske, Bettina; Hanns, Stephanie; Luck, Tobias; Angermeyer, Matthias C; Behrens, Johann; Riedel-Heller, Steffi G

    2007-10-01

    We reviewed studies of in-service interventions for caregivers of persons with dementia in nursing homes published between 1990 and 2004. The aim was to obtain an overview of the evaluated interventions and to characterize their methodological quality. A thorough literature search was conducted, including searching electronic databases for selected intervention studies and previous reviews. Selected studies were summarized and compared along certain categories, and methodological quality was assessed. A total of 21 studies were identified, mostly published in the United States. Most were of poor methodological quality. Although nearly all reported positive effects, their results must be interpreted cautiously due to methodological weaknesses. Extensive interventions with ongoing support successfully demonstrated sustained implementation of new knowledge. Owing to methodological weaknesses and a lack of follow-up evaluations, little or no evidence existed for the efficacy or, particularly, the transfer of knowledge in simpler interventions when reinforcing and enabling factors were not present. On an international and, particularly, on a national level a lack of evaluated in-service training programs for caregivers in homes for people with dementia is apparent. Methodological weakness is common. This study highlights the need for well-defined methodologically improved studies, providing conclusive evidence of the effects of intervention types to help improve the quality of dementia care.

  12. 78 FR 63217 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

    ... Food-Contact Articles AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug... information to OMB for review and clearance. Threshold of Regulation for Substances Used in Food-Contact...

  13. 76 FR 80948 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-27

    ... developed to promote the initiation of clinical investigations to evaluate the medical devices under FDA's... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions...

  14. 78 FR 6822 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-31

    ... Office of Management and Budget Review; Comment Request; Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business Qualification and Certification AGENCY... announcing that a proposed collection of information has been submitted to the Office of Management...

  15. Implications of the FDA statement on transvaginal placement of mesh: the aftermath.

    PubMed

    Koski, Michelle E; Rovner, Eric S

    2014-02-01

    The release of the U.S. Food and Drug Administration (FDA) safety communication on the use of transvaginal mesh (TVM) for pelvic organ prolapse (POP) has resulted in changes in the pelvic reconstruction community. This monograph reviews the implications of the FDA statements over the last 18-24 months. Recent findings show that there have been significant developments in the areas of regulatory mandates, media and medico-legal activity, and statements from surgical societies. In summary, well-publicized communications from the FDA and major medical organizations are defining a change in the use of TVM for POP.

  16. Pharmacogenomic Biomarkers: an FDA Perspective on Utilization in Biological Product Labeling.

    PubMed

    Schuck, Robert N; Grillo, Joseph A

    2016-05-01

    Precision medicine promises to improve both the efficacy and safety of therapeutic products by better informing why some patients respond well to a drug, and some experience adverse reactions, while others do not. Pharmacogenomics is a key component of precision medicine and can be utilized to select optimal doses for patients, more precisely identify individuals who will respond to a treatment and avoid serious drug-related toxicities. Since pharmacogenomic biomarker information can help inform drug dosing, efficacy, and safety, pharmacogenomic data are critically reviewed by FDA staff to ensure effective use of pharmacogenomic strategies in drug development and appropriate incorporation into product labels. Pharmacogenomic information may be provided in drug or biological product labeling to inform health care providers about the impact of genotype on response to a drug through description of relevant genomic markers, functional effects of genomic variants, dosing recommendations based on genotype, and other applicable genomic information. The format and content of labeling for biologic drugs will generally follow that of small molecule drugs; however, there are notable differences in pharmacogenomic information that might be considered useful for biologic drugs in comparison to small molecule drugs. Furthermore, the rapid entry of biologic drugs for treatment of rare genetic diseases and molecularly defined subsets of common diseases will likely lead to increased use of pharmacogenomic information in biologic drug labels in the near future. In this review, we outline the general principles of therapeutic product labeling and discuss the utilization of pharmacogenomic information in biologic drug labels.

  17. The effect of nutrition training for health care staff on learner and patient outcomes in adults: a systematic review and meta-analysis.

    PubMed

    Marples, Owen; Baldwin, Christine; Weekes, C Elizabeth

    2017-07-01

    Background: Nutrition training for health care staff has been prioritized internationally as a key means of tackling malnutrition; however, there is a lack of clear evidence to support its implementation. Systematic reviews in other fields of training for health care staff indicate that training strategies may have a beneficial impact on learner and patient outcomes.Objectives: We assessed whether nutrition training for health care staff caring for nutritionally vulnerable adults resulted in improved learner and patient outcomes and evaluated the effectiveness of different training strategies.Design: A systematic review of trials of nutrition training for health care staff was conducted. Six databases were searched with key terms relating to malnutrition and nutrition training. Studies were categorized according to cognitive (didactic teaching), behavioral (practical implementation of skills), and psychological (individualized or group feedback and reflection) training strategies. Where sufficient data were available, meta-analysis was performed according to study design and training strategy. All study designs were eligible. The risk of bias was evaluated in accordance with Cochrane guidance.Results: Twenty-four studies met the eligibility criteria: 1 randomized controlled trial, 4 nonrandomized controlled trials, 3 quasi-experimental trials, 13 longitudinal pre-post trials, 2 qualitative studies, and 1 cross-sectional survey. Results from a number of low-quality studies suggest that nutrition training for health care staff may have a beneficial effect on staff nutrition knowledge, practice, and attitude as well as patient nutritional intake. There were insufficient data to determine whether any particular training strategy was more effective than the others.Conclusions: In the absence of high-quality evidence, low-quality studies suggest that nutrition training for health care staff has some positive effects. However, further randomized controlled trials are

  18. Staff Caricatures

    ERIC Educational Resources Information Center

    Templeton, Kristine

    2010-01-01

    This article describes how the author brings staff and students together through an art project that deals with caricatures. The author started with a lesson on caricature, and she made a PowerPoint presentation showcasing the work of Al Hirschfeld. Using photos of the staff, students created portraits and hung them in a main hallway after school.…

  19. Integration of new technology into clinical practice after FDA approval.

    PubMed

    Govil, Ashul; Hao, Steven C

    2016-10-01

    Development of new medical technology is a crucial part of the advancement of medicine and our ability to better treat patients and their diseases. This process of development is long and arduous and requires a significant investment of human, financial and material capital. However, technology development can be rewarded richly by its impact on patient outcomes and successful sale of the product. One of the major regulatory hurdles to technology development is the Food and Drug Administration (FDA) approval process, which is necessary before a technology can be marketed and sold in the USA. Many businesses, medical providers and consumers believe that the FDA approval process is the only hurdle prior to use of the technology in day-to-day care. In order for the technology to be adopted into clinical use, reimbursement for both the device as well as the associated work performed by physicians and medical staff must be in place. Work and coverage decisions require Current Procedural Terminology (CPT) code development and Relative Value Scale Update Committee (RUC) valuation determination. Understanding these processes is crucial to the timely availability of new technology to patients and providers. Continued and better partnerships between physicians, industry, regulatory bodies and payers will facilitate bringing technology to market sooner and ensure appropriate utilization.

  20. Reflections on the US FDA's Warning on Direct-to-Consumer Genetic Testing.

    PubMed

    Yim, Seon-Hee; Chung, Yeun-Jun

    2014-12-01

    In November 2013, the US Food and Drug Administration (FDA) sent a warning letter to 23andMe, Inc. and ordered the company to discontinue marketing of the 23andMe Personal Genome Service (PGS) until it receives FDA marketing authorization for the device. The FDA considers the PGS as an unclassified medical device, which requires premarket approval or de novo classification. Opponents of the FDA's action expressed their concerns, saying that the FDA is overcautious and paternalistic, which violates consumers' rights and might stifle the consumer genomics field itself, and insisted that the agency should not restrict direct-to-consumer (DTC) genomic testing without empirical evidence of harm. Proponents support the agency's action as protection of consumers from potentially invalid and almost useless information. This action was also significant, since it reflected the FDA's attitude towards medical application of next-generation sequencing techniques. In this review, we followed up on the FDA-23andMe incident and evaluated the problems and prospects for DTC genetic testing.

  1. What's next after 50 years of psychiatric drug development: an FDA perspective.

    PubMed

    Laughren, Thomas P

    2010-09-01

    This article discusses changes in psychiatric drug development from a US Food and Drug Administration (FDA) standpoint. It first looks back at changes that have been influenced by regulatory process and then looks forward at FDA initiatives that are likely to affect psychiatric drug development in the future. FDA protects the public health by ensuring the safety and efficacy of drug products introduced into the US market. FDA works with drug sponsors during development, and, when applications are submitted, reviews the safety and efficacy data and the proposed labeling. Drug advertising and promotion and postmarketing surveillance also fall within FDA's responsibility. Among the many changes in psychiatric drug development over the past 50 years, several have been particularly influenced by FDA. Populations studied have expanded diagnostically and demographically, and approved psychiatric indications have become more focused on the clinical entities actually studied, including in some cases specific symptom domains of recognized syndromes. Trial designs have become increasingly complex and informative, and approaches to data analysis have evolved to better model the reality of clinical trials. This article addresses 2 general areas of innovation at FDA that will affect psychiatric drug development in years to come. Several programs falling under the general heading of the Critical Path Initiative, ie, biomarkers, adaptive design, end-of-phase 2A meetings, and data standards, are described. In addition, a number of important safety initiatives, including Safety First, the Sentinel Initiative, the Safe Use Initiative, and meta-analysis for safety, are discussed.

  2. 42 CFR 405.203 - FDA categorization of investigational devices.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 2 2010-10-01 2010-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1)...

  3. 78 FR 19715 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

    ... HUMAN SERVICES Food and Drug Administration Implementation of the FDA Food Safety Modernization Act... comment period for the notice entitled ``Implementation of the FDA Food Safety Modernization Act Provision... Food Safety Modernization Act (FSMA), and as it implements the FSMA provisions relating to the tracking...

  4. Effectiveness of interventions to improve family-staff relationships in the care of people with dementia in residential aged care: a systematic review protocol.

    PubMed

    Nguyen, Mynhi; Pachana, Nancy A; Beattie, Elizabeth; Fielding, Elaine; Ramis, Mary-Anne

    2015-11-01

    The objective of this review is to identify and appraise existing evidence regarding the effectiveness of interventions designed to enhance staff-family relationships for people with dementia living in residential aged care facilities.More specifically, the objectives are to identify the effectiveness of constructive communication, cooperation programs, and practices or strategies to enhance family-staff relationships. The effectiveness of these interventions will be measured by comparing the intervention to no intervention, comparing one intervention with another, or comparing pre- and post-interventions.Specifically the review question is: What are the most effective interventions for improving communication and cooperation to enhance family-staff relationships in residential aged care facilities? In our aging world, dementia is prevalent and is a serious health concern affecting approximately 35.6 million people worldwide. This figure is expected to increase two-fold by 2030 and three-fold by 2050. Although younger-onset dementia is increasingly recognized, dementia is most commonly a disease that affects the elderly. Among those aged 65 to 85, the prevalence of dementia increases exponentially, and doubles with every five-year increase in age.Dementia is defined as a syndrome, commonly chronic or progressive in nature, and caused by a range of brain disorders that affect memory, thinking and the ability to perform activities of daily living. While the rate of progression and manifestation of decline differs, all cases of dementia share a similar trajectory of decline. The progressive decline in cognitive functions and ultimately physical function that these people face affects not only the person with the disease but also their family caregivers and health care staff.The manifestation of dementia presents unique and extreme challenges for the family caregiver. Generally it causes great physical, emotional and social strain because the caregiving process is long

  5. Consistent Assignment of Nursing Staff to Residents in Nursing Homes: A Critical Review of Conceptual and Methodological Issues

    PubMed Central

    Roberts, Tonya; Nolet, Kimberly; Bowers, Barbara

    2015-01-01

    Purpose of Study: Consistent assignment of nursing staff to residents is promoted by a number of national organizations as a strategy for improving nursing home quality and is included in pay for performance schedules in several states. However, research has shown inconsistent effects of consistent assignment on quality outcomes. In order to advance the state of the science of research on consistent assignment and inform current practice and policy, a literature review was conducted to critique conceptual and methodological understandings of consistent assignment. Design and Methods: Twenty original research reports of consistent assignment in nursing homes were found through a variety of search strategies. Results: Consistent assignment was conceptualized and operationalized in multiple ways with little overlap from study to study. There was a lack of established methods to measure consistent assignment. Methodological limitations included a lack of control and statistical analyses of group differences in experimental-level studies, small sample sizes, lack of attention to confounds in multicomponent interventions, and outcomes that were not theoretically linked. Implications: Future research should focus on developing a conceptual understanding of consistent assignment focused on definition, measurement, and links to outcomes. To inform current policies, testing consistent assignment should include attention to contexts within and levels at which it is most effective. PMID:23996209

  6. Consistent assignment of nursing staff to residents in nursing homes: a critical review of conceptual and methodological issues.

    PubMed

    Roberts, Tonya; Nolet, Kimberly; Bowers, Barbara

    2015-06-01

    Consistent assignment of nursing staff to residents is promoted by a number of national organizations as a strategy for improving nursing home quality and is included in pay for performance schedules in several states. However, research has shown inconsistent effects of consistent assignment on quality outcomes. In order to advance the state of the science of research on consistent assignment and inform current practice and policy, a literature review was conducted to critique conceptual and methodological understandings of consistent assignment. Twenty original research reports of consistent assignment in nursing homes were found through a variety of search strategies. Consistent assignment was conceptualized and operationalized in multiple ways with little overlap from study to study. There was a lack of established methods to measure consistent assignment. Methodological limitations included a lack of control and statistical analyses of group differences in experimental-level studies, small sample sizes, lack of attention to confounds in multicomponent interventions, and outcomes that were not theoretically linked. Future research should focus on developing a conceptual understanding of consistent assignment focused on definition, measurement, and links to outcomes. To inform current policies, testing consistent assignment should include attention to contexts within and levels at which it is most effective. Published by Oxford University Press on behalf of the Gerontological Society of America 2013.

  7. The FDA's Final Rule on Expedited Safety Reporting: Statistical Considerations

    PubMed Central

    Wittes, Janet; Crowe, Brenda; Chuang-Stein, Christy; Guettner, Achim; Hall, David; Jiang, Qi; Odenheimer, Daniel; Xia, H. Amy; Kramer, Judith

    2015-01-01

    In March 2011, a Final Rule for expedited reporting of serious adverse events took effect in the United States for studies conducted under an Investigational New Drug (IND) application. In December 2012, the U.S. Food and Drug Administration (FDA) promulgated a final Guidance describing the operationalization of this Final Rule. The Rule and Guidance clarified that a clinical trial sponsor should have evidence suggesting causality before defining an unexpected serious adverse event as a suspected adverse reaction that would require expedited reporting to the FDA. The Rule's emphasis on the need for evidence suggestive of a causal relation should lead to fewer events being reported but, among those reported, a higher percentage actually being caused by the product being tested. This article reviews the practices that were common before the Final Rule was issued and the approach the New Rule specifies. It then discusses methods for operationalizing the Final Rule with particular focus on relevant statistical considerations. It concludes with a set of recommendations addressed to Sponsors and to the FDA in implementing the Final Rule. PMID:26550466

  8. [Single-family rooms for neonatal intensive care units impacts on preterm newborns, families, and health-care staff. A systematic literature review].

    PubMed

    Servel, A-C; Rideau Batista Novais, A

    2016-09-01

    The quality of the environment is an essential point in the care of preterm newborns. The design of neonatal intensive care units (NICUs) (open-bay, single-patient room, single-family room) directly affects both the preterm newborns and their caregivers (parents, healthcare staff). The aim of this systematic review was to evaluate the impact of single-family rooms on the preterm newborn, its parents, and the staff. Single-family rooms improve outcome for the preterm newborn, with increasing parental involvement and better control of the environment (fewer inappropriate stimulations such as high levels of noise and illumination). This kind of NICU design also improves parental and staff satisfaction. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  9. How drugs are developed and approved by the FDA: current process and future directions.

    PubMed

    Ciociola, Arthur A; Cohen, Lawrence B; Kulkarni, Prasad

    2014-05-01

    This article provides an overview of FDA's regulatory processes for drug development and approval, and the estimated costs associated with the development of a drug, and also examines the issues and challenges facing the FDA in the near future. A literature search was performed using MEDLINE to summarize the current FDA drug approval processes and future directions. MEDLINE was further utilized to search for all cost analysis studies performed to evaluate the pharmaceutical industry R&D productivity and drug development cost estimates. While the drug approval process remains at high risk and spans over multiple years, the FDA drug review and approval process has improved, with the median approval time for new molecular drugs been reduced from 19 months to 10 months. The overall cost to development of a drug remains quite high and has been estimated to range from $868M to $1,241M USD. Several new laws have been enacted, including the FDA Safety and Innovation Act (FDASIA) of 2013, which is designed to improve the drug approval process and enhance access to new medicines. The FDA's improved processes for drug approval and post-market surveillance have achieved the goal of providing patients with timely access to effective drugs while minimizing the risk of drug-related harm. The FDA drug approval process is not without controversy, as a number of well-known gastroenterology drugs have been withdrawn from the US market over the past few years. With the approval of the new FDASIA law, the FDA will continue to improve their processes and, working together with the ACG through the FDA-Related Matters Committee, continue to develop safe and effective drugs for our patients.

  10. The FDA and the new biology.

    PubMed

    Simari, Robert D; Chen, Horng; Burnett, John C

    2008-12-01

    The translation of basic science discoveries to clinical application is dependent on the demonstrated efficacy in humans of the technology but even as importantly on the therapeutic agent or device conforming to the standards of the US Food and Drug Administration (FDA) leading to approval. In this editorial, we propose that the FDA consider a modified process to support the more rapid development of novel agents while furthering the understanding of the risk and benefits of new therapeutics as they are utilized following approval.

  11. Of poops and parasites: unethical FDA overregulation.

    PubMed

    Young, Kenneth A

    2014-01-01

    Therapies born out of the Hygiene Hypothesis--such as helminthic therapy and fecal bacteriotherapy--provide a compelling example of the FDA's institutional blindness. Unlike the traditional pharmaceutical model of treatment, therapies based in the Hygiene Hypothesis purport to resolve or alleviate conditions by reintroducing organisms once thought to be wholly negative. While questions of negative effects and safety remain in the former, they are largely absent in the latter. Nonetheless, the FDA has chosen to regulate the use of both helminthic therapy and fecal bacteriotherapy. Such restriction of doctor-patient autonomy in the name of efficacy is costly and unethical.

  12. FDA approved drugs as potential Ebola treatments

    PubMed Central

    Ekins, Sean; Coffee, Megan

    2015-01-01

    In the search for treatments for the Ebola Virus, multiple screens of FDA drugs have led to the identification of several with promising in vitro activity. These compounds were not originally developed as antivirals and some have been further tested in mouse in vivo models. We put forward the opinion that some of these drugs could be evaluated further and move into the clinic as they are already FDA approved and in many cases readily available. This may be important if there is a further outbreak in future and no other therapeutic is available. PMID:25789163

  13. Quality assessment of digital annotated ECG data from clinical trials by the FDA ECG Warehouse.

    PubMed

    Sarapa, Nenad

    2007-09-01

    The FDA mandates that digital electrocardiograms (ECGs) from 'thorough' QTc trials be submitted into the ECG Warehouse in Health Level 7 extended markup language format with annotated onset and offset points of waveforms. The FDA did not disclose the exact Warehouse metrics and minimal acceptable quality standards. The author describes the Warehouse scoring algorithms and metrics used by FDA, points out ways to improve FDA review and suggests Warehouse benefits for pharmaceutical sponsors. The Warehouse ranks individual ECGs according to their score for each quality metric and produces histogram distributions with Warehouse-specific thresholds that identify ECGs of questionable quality. Automatic Warehouse algorithms assess the quality of QT annotation and duration of manual QT measurement by the central ECG laboratory.

  14. Reform at FDA: faster access to promising drugs? Food and Drug Administration.

    PubMed

    Baker, R

    1995-06-01

    The Food and Drug Administration (FDA), the government agency responsible for ensuring that drugs, vaccines, and medical devices are safe and effective, is under hot debate by Congress, the Clinton administration, and the AIDS community. The Clinton/Gore proposal favors excluding drug and biologic manufacturers from requirements for more environmental assessments and only indirectly addresses drug development. Oregon Democratic Congressman Ron Wyden introduced an FDA reform bill which calls for the FDA to use expert panels, independent testing organizations, and institutional review boards (IRB) to help speed new drugs and devices through the approval process. The bill calls for the use of the IRB for the approval (or denial) of applications for Phase I review of new drugs. Not surprisingly, the AIDS community has differing views on the reform at the FDA. The Treatment Action Group (TAG), whose members hold key positions in well-known AIDS groups, supports the status quo at FDA and is lobbying AIDS organizations across the country to sign on to its FDA Reform Principles. Other AIDS treatment activists, such as members of ACT UP, favor local IRB jurisdiction over Phase I research.

  15. 75 FR 76992 - Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-10

    ... recommendations regarding financial disclosure by persons participating in the OPH portion of advisory committee... disclosure of financial relationships relevant to the meeting topic. We received two comments on the draft... respects, including with regard to how the OPH session is conducted and instructions regarding...

  16. 76 FR 17159 - Office of New Reactors; Final Interim Staff Guidance on Standard Review Plan, Section 17.4...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-28

    ... clarify the NRC staff guidance on the design reliability assurance program (RAP). This ISG updates the... RAP during the design stage, which is specified in the ISG. This final issuance incorporates...

  17. 76 FR 58311 - Draft License Renewal Interim Staff Guidance LR-ISG-2011-05; Ongoing Review of Operating Experience

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-20

    ... request from the Nuclear Energy Institute (NEI), the NRC is extending the public comment period until... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY... Experience AGENCY: Nuclear Regulatory Commission. ACTION: Draft interim staff guidance; extension of...

  18. Vagus nerve stimulation therapy summary: five years after FDA approval.

    PubMed

    Schachter, Steven C

    2002-09-24

    With more than 16,000 patients implanted with the vagus nerve stimulation (VNS) therapy system (Cyberonics, Inc., Houston, Texas), VNS therapy has assumed an increasingly important role in the treatment of medically refractory seizures since its approval 5 years ago by the United States FDA. This review discusses the clinical trials that provided evidence for the approval, long-term efficacy, efficacy in special populations and co-morbid conditions, and safety and tolerability. Additional studies are suggested to further explore the capabilities of VNS therapy.

  19. Effectiveness of team nursing compared with total patient care on staff wellbeing when organizing nursing work in acute care wards: a systematic review.

    PubMed

    King, Allana; Long, Lesley; Lisy, Karolina

    2015-11-01

    The organization of the work of nurses, according to recognized models of care, can have a significant impact on the wellbeing and performance of nurses and nursing teams. This review focuses on two models of nursing care delivery, namely, team and total patient care, and their effect on nurses' wellbeing. To examine the effectiveness of team nursing compared to total patient care on staff wellbeing when organizing nursing work in acute care wards. Participants were nurses working on wards in acute care hospitals.The intervention was the use of a team nursing model when organizing nursing work. The comparator was the use of a total patient care model.This review considered quantitative study designs for inclusion in the review.The outcome of interest was staff wellbeing which was measured by staff outcomes in relation to job satisfaction, turnover, absenteeism, stress levels and burnout. The search strategy aimed to find both published and unpublished studies from 1995 to April 21, 2014. Quantitative papers selected for retrieval were assessed by two independent reviewers for methodological validity prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute. Data was extracted from papers included in the review using the standardized data extraction tool from the Joanna Briggs Institute. The data extracted included specific details about the interventions, populations, study methods and outcomes of significance to the review question and its specific objectives. Due to the heterogeneity of the included quantitative studies, meta-analysis was not possible. Results have been presented in a narrative form. The database search returned 10,067 records. Forty-three full text titles were assessed, and of these 40 were excluded, resulting in three studies being included in the review. Two of the studies were quasi experimental designs and the other was considered an uncontrolled before and after experimental study

  20. 76 FR 12742 - Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-08

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... Treatment of Urinary Incontinence.'' This guidance document describes FDA's recommendations for clinical...

  1. Do interventions with staff in long-term residential facilities improve quality of care or quality for life people with dementia? A systematic review of the evidence.

    PubMed

    Bird, Mike; Anderson, Katrina; MacPherson, Sarah; Blair, Annaliese

    2016-12-01

    Common sense suggests and research indicates relationships between staff factors in residential dementia care and quality of life (QOL) for residents, with poor care increasing suffering. However, we do not have a coherent picture of which staff interventions have an impact on quality of care (QOC) or resident QOL. A comprehensive search of 20 years' peer-reviewed literature using Medline, PsycINFO, Embase, PubMed, CINAHL, and the Cochrane, Campbell Collaboration identified 4,760 studies meriting full text review. Forty-six met the inclusion criteria, namely interventions in long-term facilities helping staff develop their capacity to provide better care and/or QOL for residents with dementia. Thirty-five other papers comprised an associated predictor review. Conclusions from these limited data are further compromised because nine studies failed to measure effects on residents and only half assessed effects after the project team withdrew. Of these, excellent studies produced change over the medium (3-4 months) or longer term, including reduction in challenging behavior and restraint use but this applied only to a minority. A number of studies failed to measure effects on QOC, limiting conclusions about mechanisms underlying change. In general, level of intervention required depended on the target. For outcomes like restraint use, structured education sessions with some support appear adequate. Programs to reduce pain require more support. For complicated issues like challenging behavior and increasing co-operation in showering, detailed, supportive, on-site interventions are required. Improvements in restraint and staff/resident interactions were the most promising findings. (Review registration number: PROSPERO 2014:CRD42014015224).

  2. 76 FR 80947 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-27

    ... Staff; Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies; Extension of Comment Period AGENCY: Food and Drug Administration... approaches FDA intends to facilitate early feasibility studies of medical devices, using appropriate risk...

  3. Access to Investigational Drugs: FDA Expanded Access Programs or “Right‐to‐Try” Legislation?

    PubMed Central

    Berglund, Jelena P.; Weatherwax, Kevin; Gerber, David E.; Adamo, Joan E.

    2015-01-01

    Abstract Purpose The Food and Drug Administration Expanded Access (EA) program and “Right‐to‐Try” legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access. Methods FDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared. Results The FDA EA program includes Single Patient‐Investigational New Drug (SP‐IND), Emergency SP‐IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. “Right‐to‐Try” legislation bypasses some of these steps, but provides no regulatory or safety oversight. Conclusion The FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP‐IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements. PMID:25588691

  4. Access to Investigational Drugs: FDA Expanded Access Programs or "Right-to-Try" Legislation?

    PubMed

    Holbein, M E Blair; Berglund, Jelena P; Weatherwax, Kevin; Gerber, David E; Adamo, Joan E

    2015-10-01

    The Food and Drug Administration Expanded Access (EA) program and "Right-to-Try" legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access. FDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared. The FDA EA program includes Single Patient-Investigational New Drug (SP-IND), Emergency SP-IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. "Right-to-Try" legislation bypasses some of these steps, but provides no regulatory or safety oversight. The FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP-IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements. © 2015 Wiley Periodicals, Inc.

  5. Assessment of foetal risk associated with 93 non-US-FDA approved medications during pregnancy

    PubMed Central

    Al-jedai, Ahmed H.; Balhareth, Sakra S.; Algain, Roaa A.

    2012-01-01

    Health care practitioners utilize the United States-Food and Drug Administration (US-FDA) pregnancy categorization (A, B, C, D, X) for making decision on the appropriateness of certain medications during pregnancy. Many non US-FDA approved medications are registered and marketed in Saudi Arabia. However, these medications do not have an assigned pregnancy risk categorization like those approved in the US. The objective of this review is to evaluate, report, and categorize the foetal risk associated with non-US-FDA approved medications registered by the Saudi Food and Drug Authority (S-FDA) according to the US-FDA pregnancy risk categorization system. We identified 109 non-US-FDA approved medications in the Saudi National Formulary (SNF) as of October 2007. We searched for data on functional or anatomical birth defects or embryocidal-associated risk using different databases and references. An algorithm for risk assessment was used to determine a pregnancy risk category for each medication. Out of 93 eligible medications, 73% were assigned category risk C, 10 medications (11%) were assigned category risk D, and 12 medications (13%) were assigned category risk B. Only three medications were judged to be safe during pregnancy based on the available evidence and were assigned category risk A. Inconsistencies in defining and reporting the foetal risk category among different drug regulatory authorities could create confusion and affect prescribing. We believe that standardization and inclusion of this information in the medication package insert is extremely important to all health care practitioners. PMID:23960803

  6. ADHD medication use following FDA risk warnings.

    PubMed

    Barry, Colleen L; Martin, Andres; Busch, Susan H

    2012-09-01

    In 2006, the U.S. Food and Drug Administration (FDA) investigated cardiac and psychiatric risks associated with attention deficit/hyperactivity disorder (ADHD) medication use. To examine how disclosure of safety risks affected pediatric ADHD use, and to assess news media coverage of the issue to better understand trends in treatment patterns. We used the AHRQ's Medical Expenditure Panel Survey (MEPS), a nationally representative household panel survey, to calculate unadjusted rates of pediatric ADHD use from 2002 to 2008 overall and by parents' education. We examined whether children (ages 0 to 20) filled a prescription for any ADHD medication during the calendar year. Next, we used content analysis methods to analyze news coverage of the issue in 10 high-circulation newspapers, the 3 major television networks and a major cable news network in the U.S. We examined 6 measures capturing information conveyed on risk and benefits of ADHD medication use. No declines in medication use following FDA safety warnings overall or by parental education level were observed. News media coverage was relatively balanced in its portrayal of the risks and benefits of ADHD medication use by children. ADHD risk warnings were not associated with large declines in medication use, and balanced news coverage may have contributed to the treatment patterns observed. Self-reported surveys like the MEPS rely on the recall of respondents and may be subject to reporting bias. However, the validity of these data is supported by their consistency with other data on drug use from other sources. These findings are in direct contrast to the substantial declines in use observed after pediatric antidepressant risk warnings in the context of a news media environment that emphasized risks over benefits. Our findings are relevant to the ongoing discussion about improving the FDA's ability to monitor drug safety. Safety warnings occur amid ongoing concern that the agency has insufficient authority and

  7. Hospital staff nurses' work hours, meal periods, and rest breaks. A review from an occupational health nurse perspective.

    PubMed

    Witkoski, Amy; Dickson, Victoria Vaughan

    2010-11-01

    Registered nurses are the largest group of health care providers in the United States. To provide 24-hour care, hospital staff nurses often work long hours and consecutive shifts, without adequate meal or rest breaks. Serious declines in functioning related to provider fatigue can lead to safety issues for patients and nurses alike. The occupational health nurse can assess the effects of nurses' work hours and break periods on employee health, educate staff on the importance of sleep and deleterious effects of fatigue, and implement programs to improve the work environment. This article examines nurses' work hours, break and meal period laws and regulations, and the role of the occupational health nurse in caring for this group of employees. Overall findings suggest that the expertise of an occupational health nurse in the hospital setting could significantly improve the health and safety of staff nurses.

  8. Staff Development.

    ERIC Educational Resources Information Center

    Reusswig, James, Ed.; Ponzio, Richard, Ed.

    1980-01-01

    Eight essays are presented which reflect current problems, issues, and practices related to the development of teacher and administrator expertise. The authors are school district and public school administrators, faculty of schools of education, and a director of staff development in a state department of education. The topics treated are: (1)…

  9. Screening, HPV Vaccine Can Prevent Cervical Cancer: FDA

    MedlinePlus

    ... medlineplus.gov/news/fullstory_163464.html Screening, HPV Vaccine Can Prevent Cervical Cancer: FDA Agency recommends getting ... by the human papillomavirus (HPV). An FDA-approved vaccine called Gardasil 9 protects against 9 HPV types ...

  10. Mining FDA drug labels for medical conditions

    PubMed Central

    2013-01-01

    Background Cincinnati Children’s Hospital Medical Center (CCHMC) has built the initial Natural Language Processing (NLP) component to extract medications with their corresponding medical conditions (Indications, Contraindications, Overdosage, and Adverse Reactions) as triples of medication-related information ([(1) drug name]-[(2) medical condition]-[(3) LOINC section header]) for an intelligent database system, in order to improve patient safety and the quality of health care. The Food and Drug Administration’s (FDA) drug labels are used to demonstrate the feasibility of building the triples as an intelligent database system task. Methods This paper discusses a hybrid NLP system, called AutoMCExtractor, to collect medical conditions (including disease/disorder and sign/symptom) from drug labels published by the FDA. Altogether, 6,611 medical conditions in a manually-annotated gold standard were used for the system evaluation. The pre-processing step extracted the plain text from XML file and detected eight related LOINC sections (e.g. Adverse Reactions, Warnings and Precautions) for medical condition extraction. Conditional Random Fields (CRF) classifiers, trained on token, linguistic, and semantic features, were then used for medical condition extraction. Lastly, dictionary-based post-processing corrected boundary-detection errors of the CRF step. We evaluated the AutoMCExtractor on manually-annotated FDA drug labels and report the results on both token and span levels. Results Precision, recall, and F-measure were 0.90, 0.81, and 0.85, respectively, for the span level exact match; for the token-level evaluation, precision, recall, and F-measure were 0.92, 0.73, and 0.82, respectively. Conclusions The results demonstrate that (1) medical conditions can be extracted from FDA drug labels with high performance; and (2) it is feasible to develop a framework for an intelligent database system. PMID:23617267

  11. [Occupational Exposure to Psychosocial Factors and Presence of Musculoskeletal disorders in Nursing Staff: A review of Studies and Meta-Analysis].

    PubMed

    Ballester Arias, Antonio Ramón; García, Ana María

    2017-04-07

    There is scientific evidence that psychosocial factors are significantly associated with discomfort and / or pain musculoskeletal complaints in nursing staff. The objective of the research was to analyze the association between occupational exposure to psychosocial factors at work and musculoskeletal damage in nursing staff. Systematic review and meta-analysis of studies published up to 2015 in English, French, Italian, Portuguese or Spanish evaluating the association between musculoskeletal disorders and psychosocial factors in the work of nursing staff. A search was made using the same strategies in the bibliographic databases Web of Science, MEDLINE (Pubmed), NIOSHIC and CINAHL. We assessed the quality of eligible studies, heterogeneity, and sensitivity analyzes. 64 studies were reviewed and quality criteria were accepted, accepting those of medium and high quality (n = 47). In a second screening, those that did not meet inclusion criteria were eliminated, with 36 studies being included in the meta-analysis. Statistically significant associations were found between high demands with discomfort and / or pain neck (OR 1.55, IC95%: 1.39-1.72). And between the effort-reward imbalance with discomfort and / or pain in any body region (OR 2.56, IC95%: 1.59-4.11). Heterogeneity was generally average and low for most subsets of the meta-analysis. Occupational exposure to psychosocial factors is associated with discomfort and / or pain in different body areas. Therefore, the improvement of the psychosocial environment has an impact on the reduction and prevention of musculoskeletal disorders.

  12. Classroom-based and distance learning education and training courses in end-of-life care for health and social care staff: a systematic review.

    PubMed

    Pulsford, David; Jackson, Georgina; O'Brien, Terri; Yates, Sue; Duxbury, Joy

    2013-03-01

    Staff from a range of health and social care professions report deficits in their knowledge and skills when providing end-of-life and palliative care, and education and training has been advocated at a range of levels. To review the literature related to classroom-based and distance learning education and training initiatives for health and social care staff in end-of-life and palliative care, in terms of their target audience, extent, modes of delivery, content and teaching and learning strategies, and to identify the most effective educational strategies for enhancing care. A systematic review of the literature evaluating classroom-based and distance learning education and training courses for health and social care staff in end-of-life and palliative care. Online databases CINAHL, MEDLINE, EMBASE and PSYCHINFO between January 2000 and July 2010. Studies were selected that discussed specific education and training initiatives and included pre-and post-test evaluation of participants' learning. 30 studies met eligibility criteria. The majority reported successful outcomes, though there were some exceptions. Level of prior experience and availability of practice reinforcement influenced learning. Participative and interactive learning strategies were predominantly used along with discussion of case scenarios. Multi-professional learning was infrequently reported and service user and carer input to curriculum development and delivery was reported in only one study. Classroom-based education and training is useful for enhancing professionals' skills and perceived preparedness for delivering end-of-life care but should be reinforced by actual practice experience.

  13. A systematic review of the relationship between staff perceptions of organizational readiness to change and the process of innovation adoption in substance misuse treatment programs.

    PubMed

    Kelly, Peter; Hegarty, Josephine; Barry, Joe; Dyer, Kyle R; Horgan, Aine

    2017-09-01

    Translating innovation, such as contemporary research evidence, into policy and practice is a challenge, not just in substance misuse treatment programs, but across all spheres of healthcare. Organizational readiness to change (ORC) has been described as a fundamental concept, and an important determinant of the process of innovation adoption. The aim of this review was to describe the relationship between staff perceptions of ORC and the process of innovation adoption: exposure, adoption, implementation and integration into practice, in substance misuse treatment programs. This systematic review was conducted in accordance with PRISMA guidelines and fourteen papers were identified as being eligible for inclusion. This review was designed to include all constructs of ORC, but only one tool was used in all of the included papers. Despite this, the heterogeneity of studies in this review made a direct comparison of ORC related variables challenging. None of the included papers clearly related to one stage of the process of innovation adoption, and all of the included papers related to the early stages of the process. Only one paper attempted to measure the sustained integration of an innovation into practice. Overall, the papers were assessed as being low in terms of evidential hierarchy and the quality of the papers was assessed as being on average fair. ORC measurements provide us with a measure of organizational functioning which can be important in terms of predicting how successfully new innovations are adopted. Motivation for change was high in programs where staff identified more program deficits and these staff could also identify more specific needs, but were less likely to have exposure to new innovations. Better program resources and specific staff attributes, increase the likely hood of successful innovation adoption. A good organizational climate is potentially the strongest predictor for the adoption of new practices. It may be beneficial to measure ORC

  14. Assessing User Perceptions of Staff Training Requirements in the Substance Use Workforce: A Review of the Literature

    ERIC Educational Resources Information Center

    Wylie, Leon W. J.

    2010-01-01

    Although the potential range of the workforce that may positively interact with substance users is large, and takes in all who may have to deal with substance use issues in some way, the literature mainly focuses on user views of specialist substance use or health and social care staff. With client-centred care a key policy of modern service…

  15. 75 FR 71702 - Science Advisory Board Staff Office; Request for Nominations of Experts for Review of EPA's Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-24

    ... Technical Report Pertaining to Uranium and Thorium In-Situ Leach Recovery and Post-Closure Stability... technical report, which will be used as a basis to evaluate the technical and scientific issues pertaining... Board (SAB) Staff Office is requesting public nominations for technical experts to augment the...

  16. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...

  17. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...

  18. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...

  19. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...

  20. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Focused FDA regulatory research. 312.86...

  1. 21 CFR 316.34 - FDA recognition of exclusive approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false FDA recognition of exclusive approval. 316.34... (CONTINUED) DRUGS FOR HUMAN USE ORPHAN DRUGS Orphan-drug Exclusive Approval § 316.34 FDA recognition of exclusive approval. (a) FDA will send the sponsor (or, the permanent-resident agent, if applicable)...

  2. 21 CFR 812.30 - FDA action on applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA action on applications. 812.30 Section 812.30...) MEDICAL DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of the...

  3. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA access to records. 806.30 Section 806.30 Food... DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to... designated by FDA and under section 704(e) of the act, permit such officer or employee at all...

  4. 21 CFR 812.42 - FDA and IRB approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have...

  5. Does organizational climate impact upon burnout in staff who work with people with intellectual disabilities? A systematic review of the literature.

    PubMed

    Thompson, Lauren; Rose, John

    2011-09-01

    Staff stress and burnout is a prominent area of research in relation to services for people with intellectual disabilities. The aim of this article is to review the literature in relation to organizational climate in order to investigate whether there is a relationship between organizational variables and staff burnout. A systematic literature search yielded 21 articles which fell into two categories. Earlier studies tended to focus on deinstitutionalization, whereas later studies appeared to be influenced by work-stress theories, including 'person-environment fit' and demand control. Overall, it was found that an organizational climate that has a better 'person-environment' fit promotes greater job satisfaction and reduced burnout. Future research could focus upon the social or therapeutic aspects of the environment within services for people with intellectual disabilities to address an area of research which appears to have been overlooked.

  6. Staff Differentiation. An Annotated Bibliography.

    ERIC Educational Resources Information Center

    Marin County Superintendent of Schools, Corte Madera, CA.

    This annotated bibliography reviews selected literature focusing on the concept of staff differentiation. Included are 62 items (dated 1966-1970), along with a list of mailing addresses where copies of individual items can be obtained. Also a list of 31 staff differentiation projects receiving financial assistance from the U.S. Office of Education…

  7. 78 FR 950 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-07

    ... Program and Meetings With FDA Staff; Withdrawal AGENCY: Food and Drug Administration, HHS. ACTION: Withdrawal of notice. SUMMARY: This document withdraws a Food and Drug Administration (FDA) notice that....Gittleson@fda.hhs.gov . SUPPLEMENTARY INFORMATION: FDA published a notice in the Federal Register...

  8. The impact of a Critical Care Information System (CCIS) on time spent charting and in direct patient care by staff in the ICU: a review of the literature.

    PubMed

    Mador, Rebecca L; Shaw, Nicola T

    2009-07-01

    The introduction of a Critical Care Information System (CCIS) into an intensive care unit (ICU) is purported to reduce the time health care providers (HCP) spend on documentation and increase the time available for direct patient care. However, there is a paucity of rigorous empirical research that has investigated these assertions. Moreover, those studies that have sought to elucidate the relationship between the introduction of a CCIS and the time spent by staff on in/direct patient care activities have published contradictory findings. The objective of this literature review is to establish the impact of a CCIS on time spent documenting and in direct patient care by staff in the ICU. Five electronic databases were searched including PubMed Central, EMBASE, CINAHL, IEEE Xplore, and the Cochrane Database of Systematic Reviews. Reference lists of all published papers were hand searched, and citations reviewed to identify extra papers. We included studies that were empirical articles, published in English, and provided original data on the impact of a CCIS on time spent documenting and in direct patient care by staff in the ICU. In total, 12 articles met the inclusion criteria. Workflow analysis (66%) and time-and-motion analysis (25%) were the most common forms of data collection. Three (25%) studies found an increase in time spent charting, five (42%) found no difference, and four (33%) studies reported a decrease. Results on the impact of a CCIS on direct patient care were similarly inconclusive. Due to the discrepant findings and several key methodological issues, the impact of a CCIS on time spent charting and in direct patient care remains unclear. This review highlights the need for an increase in rigorous empirical research in this area and provides recommendations for the design and implementation of future studies.

  9. Evaluation of genotoxicity testing of FDA approved large molecule therapeutics.

    PubMed

    Sawant, Satin G; Fielden, Mark R; Black, Kurt A

    2014-10-01

    Large molecule therapeutics (MW>1000daltons) are not expected to enter the cell and thus have reduced potential to interact directly with DNA or related physiological processes. Genotoxicity studies are therefore not relevant and typically not required for large molecule therapeutic candidates. Regulatory guidance supports this approach; however there are examples of marketed large molecule therapeutics where sponsors have conducted genotoxicity studies. A retrospective analysis was performed on genotoxicity studies of United States FDA approved large molecule therapeutics since 1998 identified through the Drugs@FDA website. This information was used to provide a data-driven rationale for genotoxicity evaluations of large molecule therapeutics. Fifty-three of the 99 therapeutics identified were tested for genotoxic potential. None of the therapeutics tested showed a positive outcome in any study except the peptide glucagon (GlucaGen®) showing equivocal in vitro results, as stated in the product labeling. Scientific rationale and data from this review indicate that testing of a majority of large molecule modalities do not add value to risk assessment and support current regulatory guidance. Similarly, the data do not support testing of peptides containing only natural amino acids. Peptides containing non-natural amino acids and small molecules in conjugated products may need to be tested.

  10. Fisher, Neyman, and Bayes at FDA.

    PubMed

    Rubin, Donald B

    2016-01-01

    The wise use of statistical ideas in practice essentially requires some Bayesian thinking, in contrast to the classical rigid frequentist dogma. This dogma too often has seemed to influence the applications of statistics, even at agencies like the FDA. Greg Campbell was one of the most important advocates there for more nuanced modes of thought, especially Bayesian statistics. Because two brilliant statisticians, Ronald Fisher and Jerzy Neyman, are often credited with instilling the traditional frequentist approach in current practice, I argue that both men were actually seeking very Bayesian answers, and neither would have endorsed the rigid application of their ideas.

  11. The effect of aggression management training programmes for nursing staff and students working in an acute hospital setting. A narrative review of current literature.

    PubMed

    Heckemann, B; Zeller, A; Hahn, S; Dassen, T; Schols, J M G A; Halfens, R J G

    2015-01-01

    Patient aggression is a longstanding problem in general hospital nursing. Staff training is recommended to tackle workplace aggression originating from patients or visitors, yet evidence on training effects is scarce. To review and collate current research evidence on the effect of aggression management training for nurses and nursing students working in general hospitals, and to derive recommendations for further research. Systematic, narrative review. Embase, MEDLINE, the Cochrane library, CINAHL, PsycINFO, pubmed, psycArticles, Psychology and Behavioural Sciences Collection were searched for articles evaluating training programs for staff and students in acute hospital adult nursing in a 'before/after' design. Studies published between January 2000 and September 2011 in English, French or German were eligible of inclusion. The methodological quality of included studies was assessed with the 'Quality Assessment Tool for Quantitative Studies'. Main outcomes i.e. attitudes, confidence, skills and knowledge were collated. Nine studies were included. Two had a weak, six a moderate, and one a strong study design. All studies reported increased confidence, improved attitude, skills, and knowledge about risk factors post training. There was no significant change in incidence of patient aggression. Our findings corroborate findings of reviews on training in mental health care, which point to a lack of high quality research. Training does not reduce the incidence of aggressive acts. Aggression needs to be tackled at an organizational level. Copyright © 2014 Elsevier Ltd. All rights reserved.

  12. 78 FR 19492 - Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-01

    ... Product Development. 7. Meeting Type Being Requested (i.e., Biosimilar Initial Advisory meeting, BPD Type... detail of the data should be appropriate to the meeting type requested and the product development stage... formal meetings between FDA and sponsors or applicants relating to the development and review...

  13. FDA-Approved Anti-Obesity Drugs in the United States.

    PubMed

    Daneschvar, Homayoun L; Aronson, Mark D; Smetana, Gerald W

    2016-08-01

    Obesity is a growing health problem in our society and its treatment has been challenging. In recent decades, several anti-obesity drugs have been withdrawn from the market because of reported and documented adverse effects. After years of interruption, the US Food and Drug Administration (FDA) has recently approved multiple new anti-obesity drugs. The majority of these medications are taken orally, and only one is administered subcutaneously. In this article, we review the efficacy, adverse effects, and mechanism of action of all 5 FDA-approved drugs. Copyright © 2016 Elsevier Inc. All rights reserved.

  14. The impact of knowledge on attitudes of emergency department staff towards patients with substance related presentations: a quantitative systematic review protocol.

    PubMed

    Clarke, Diana E; Gonzalez, Miriam; Pereira, Asha; Boyce-Gaudreau, Krystal; Waldman, Celeste; Demczuk, Lisa

    2015-10-01

    University of Manitoba and Queens Joanna Briggs Collaboration for Patient Safety: a Collaborating Center of the Joanna Briggs Institute The overall objective of this systematic review is to synthesize the available evidence on the relationship between new knowledge (gained through educational interventions about substance use/abuse) and health care providers' attitudes (measured by well validated instruments such as the Drug and Drug Problems Perceptions Questionnaire [DDPPQ], the Short Alcohol and Alcohol Problems Perception Questionnaire [SAAPPQ], etc.) towards patients with substance-related presentations to emergency departments.The specific review question is: Among emergency department staff, does the acquisition of knowledge (on educational interventions about substance use) impact attitudes in relation to their therapeutic role towards patients with substance-related presentations? Substance-related emergency department (ED) visits are common worldwide. Estimates of cases with alcohol involvement presenting to the ED range from 6% to 45%. Research conducted in the UK and Australia suggests that presentations related to illicit drug use are common and have increased in recent years.In 2012, an estimated six million Canadians met the criteria for substance use disorder; alcohol was the most common substance of abuse followed by cannabis and other drugs. The relationship between substance use and physical injury is well documented. The risk of mortality is increased by the side effects of substances on users involved in accidents and trauma. Not surprisingly, substance-related ED visits have been on the rise. Although only 3 to 10% of overall visits are typically related to a primary entrance complaint of drug or alcohol use or abuse, studies estimate that up to 35% of ED visits may be directly or indirectly substance related. These reasons may range from injury resulting from accidents or violence to substance-related illnesses.Health care providers (i

  15. Evidence behind FDA alerts for drugs with adverse cardiovascular effects: implications for clinical practice.

    PubMed

    Rackham, Daniel M; C Herink, Megan; Stevens, Ian G; Cardoza, Natalie M; Singh, Harleen

    2014-01-01

    The U.S. Food and Drug Administration (FDA) periodically publishes Drug Safety Communications and Drug Alerts notifying health care practitioners and the general public of important information regarding drug therapies following FDA approval. These alerts can result in both positive and negative effects on patient care. Most clinical trials are not designed to detect long-term safety end points, and postmarketing surveillance along with patient reported events are often instrumental in signaling the potential harmful effect of a drug. Recently, many cardiovascular (CV) safety announcements have been released for FDA-approved drugs. Because a premature warning could discourage a much needed treatment or prompt a sudden discontinuation, it is essential to evaluate the evidence supporting these FDA alerts to provide effective patient care and to avoid unwarranted changes in therapy. Conversely, paying attention to these warnings in cases involving high-risk patients can prevent adverse effects and litigation. This article reviews the evidence behind recent FDA alerts for drugs with adverse CV effects and discusses the clinical practice implications.

  16. Ancestry-based pharmacogenomics, adverse reactions and carbamazepine: is the FDA warning correct?

    PubMed

    Payne, P W

    2014-10-01

    In an effort to prevent potentially fatal adverse reactions to carbamazepine, the US Food and Drug Administration (FDA) issued an alert in 2007 containing pharmacogenomic information, which is still in effect today. The alert states that carbamazepine-induced skin reactions are significantly more common in patients with the human leukocyte antigen (HLA)-B*1502 allele and that these people are almost exclusively from 'broad areas of Asia, including South Asian Indians.' This study reviews the medical evidence relied upon by the FDA and finds that the alert does not accurately reflect the medical evidence relied upon in 2007 or evidence that has been generated over the last 5 years since the label was created. The FDA drug labeling should be modified to reflect current medical evidence.

  17. The impact of educational interventions on attitudes of emergency department staff towards patients with substance-related presentations: a quantitative systematic review.

    PubMed

    Gonzalez, Miriam; Clarke, Diana E; Pereira, Asha; Boyce-Gaudreau, Krystal; Waldman, Celeste; Demczuk, Lisa; Legare, Carol

    2017-08-01

    Visits to emergency departments for substance use/abuse are common worldwide. However, emergency department health care providers perceive substance-using patients as a challenging group to manage which can lead to negative attitudes. Providing education or experience-based exercises may impact positively on behaviors towards this patient population. Whether staff attitudes are similarly impacted by knowledge acquired through educational interventions remains unknown. To synthesize available evidence on the relationship between new knowledge gained through substance use educational interventions and emergency department health care providers' attitudes towards patients with substance-related presentations. Health care providers working in urban and rural emergency departments of healthcare facilities worldwide providing care to adult patients with substance-related presentations. Quantitative papers examining the impact of substance use educational interventions on health care providers' attitudes towards substance using patients. Experimental and non-experimental study designs. Emergency department staff attitudes towards patients presenting with substance use/abuse. A three-step search strategy was conducted in August 2015 with a search update in March 2017. Studies published since 1995 in English, French or Spanish were considered for inclusion. Two reviewers assessed studies for methodological quality using critical appraisal checklists from the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI). Reviewers agreed on JBI-MAStARI methodological criteria a study must meet in order to be included in the review (e.g. appropriate use of statistical analysis). The data extraction instrument from JBI-MAStARI was used. As statistical pooling of the data was not possible, the findings are presented in narrative form. A total of 900 articles were identified as relevant for this review. Following abstract and full text

  18. 78 FR 14309 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-05

    ... appropriate technologies that enhance the tracking and tracing of foods along the supply chain from source to... ingredients (minimum of two ingredients) and (b) a selected fruit and/or vegetable along the supply chain; 7... along the Food Supply System.'' FDA is announcing the opening of a docket to provide stakeholders and...

  19. 78 FR 9396 - Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-08

    ... Staff; Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions... Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Civil Money... responses to questions FDA has received regarding the issuance of civil money penalties for violations of...

  20. 77 FR 37058 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-20

    ...] [FR Doc No: 2012-15025] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA 2012-D-0304] Draft Guidance for Industry and Food and Drug Administration Staff; Class II...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  1. 76 FR 44935 - Draft Guidance for Industry and Food and Drug Administration Staff; 510(k) Device Modifications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-27

    ...] [FR Doc No: 2011-18923] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0453] Draft Guidance for Industry and Food and Drug Administration Staff; 510(k... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA...

  2. FDA-approved small-molecule kinase inhibitors.

    PubMed

    Wu, Peng; Nielsen, Thomas E; Clausen, Mads H

    2015-07-01

    Kinases have emerged as one of the most intensively pursued targets in current pharmacological research, especially for cancer, due to their critical roles in cellular signaling. To date, the US FDA has approved 28 small-molecule kinase inhibitors, half of which were approved in the past 3 years. While the clinical data of these approved molecules are widely presented and structure-activity relationship (SAR) has been reported for individual molecules, an updated review that analyzes all approved molecules and summarizes current achievements and trends in the field has yet to be found. Here we present all approved small-molecule kinase inhibitors with an emphasis on binding mechanism and structural features, summarize current challenges, and discuss future directions in this field.

  3. An evaluation of the FDA's analysis of the costs and benefits of the graphic warning label regulation

    PubMed Central

    Chaloupka, Frank J; Warner, Kenneth E; Acemoğlu, Daron; Gruber, Jonathan; Laux, Fritz; Max, Wendy; Newhouse, Joseph; Schelling, Thomas; Sindelar, Jody

    2015-01-01

    The Family Smoking Prevention and Tobacco Control Act of 2009 gave the Food and Drug Administration (FDA) regulatory authority over cigarettes and smokeless tobacco products and authorised it to assert jurisdiction over other tobacco products. As with other Federal agencies, FDA is required to assess the costs and benefits of its significant regulatory actions. To date, FDA has issued economic impact analyses of one proposed and one final rule requiring graphic warning labels (GWLs) on cigarette packaging and, most recently, of a proposed rule that would assert FDA’s authority over tobacco products other than cigarettes and smokeless tobacco. Given the controversy over the FDA's approach to assessing net economic benefits in its proposed and final rules on GWLs and the importance of having economic impact analyses prepared in accordance with sound economic analysis, a group of prominent economists met in early 2014 to review that approach and, where indicated, to offer suggestions for an improved analysis. We concluded that the analysis of the impact of GWLs on smoking substantially underestimated the benefits and overestimated the costs, leading the FDA to substantially underestimate the net benefits of the GWLs. We hope that the FDA will find our evaluation useful in subsequent analyses, not only of GWLs but also of other regulations regarding tobacco products. Most of what we discuss applies to all instances of evaluating the costs and benefits of tobacco product regulation and, we believe, should be considered in FDA's future analyses of proposed rules. PMID:25550419

  4. Review of the national ambient air quality standards for carbon monoxide assessment of scientific and technical information. OAQPS staff paper. Final report

    SciTech Connect

    McKee, D.J.; McCurdy, T.R.; Richmond, H.M.

    1992-08-01

    The paper evaluates and interprets the updated scientific and technical information that EPA staff believes is most relevant to the review of primary (health) national ambient air quality standards for carbon monoxide. The assessment is intended to bridge the gap between the scientific review in the EPA criteria document for carbon monoxide and the judgements required of the Administrator in setting ambient air quality standards for carbon monoxide. The major recommendations of the staff paper include the following: (1) There continues to be a need to control ambient levels of carbon monoxide to protect public health; (2) Both 1-hour and 8-hour averaging times should be retained for primary carbon monoxide standards; (3) Exposure analysis results indicate relatively few individuals with angina pectoris would experience carboxyhemoglobin (COHb) levels of 2.1% or greater when exposed to carbon monoxide levels in ambient air only if current standards are attained; (4) Public health risk for COHb levels of 2.0% or lower appears to be small, if any; (5) Current 1-hour (35 ppm) and 8-hour (9 ppm) standards for carbon monoxide should be reaffirmed.

  5. Yes, We Can Improve Staff Morale.

    ERIC Educational Resources Information Center

    Clough, Dick B.

    A literature review and discussion the effect of school administrators on staff morale is presented in this paper. Four factors for improving staff morale include: a supportive workplace; meaningful incentives; a good working environment; and personal display of high morale by the administrator. Ten recommendations for improving staff relations…

  6. 19 CFR 207.64 - Staff reports.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 19 Customs Duties 3 2011-04-01 2011-04-01 false Staff reports. 207.64 Section 207.64 Customs... WHETHER INJURY TO DOMESTIC INDUSTRIES RESULTS FROM IMPORTS SOLD AT LESS THAN FAIR VALUE OR FROM SUBSIDIZED EXPORTS TO THE UNITED STATES Five-Year Reviews § 207.64 Staff reports. (a) Prehearing staff report. The...

  7. 77 FR 14403 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Norovirus Serological Reagents; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  8. 76 FR 43690 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-21

    ... Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Electrocardiograph Electrodes.'' The special controls identify the following risks to health... Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph...

  9. 78 FR 5185 - Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-24

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... the industry and FDA staff entitled ``Humanitarian Use Device (HUD) Designations.'' Devices are... HUD designations may be eligible for marketing approval under the Humanitarian Device Exemption...

  10. 76 FR 68767 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-07

    ... entitled ``Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...] [FR Doc No: 2011-28766] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0689] Draft Guidance for Industry and Food and Drug Administration Staff; De...

  11. 77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-03

    ... educate regulated industry and FDA Staff on how, when, and why to use classification product codes for... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification Product Codes; Availability AGENCY: Food and Drug Administration...

  12. FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | Poster

    Cancer.gov

    By Frank Blanchard, Staff Writer The U.S. Food and Drug Administration (FDA) recently approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected. The National Cancer Institute’s (NCI) Biopharmaceutical Development Program (BDP) at the Frederick National Laboratory for Cancer Research produced ch14.18 for the NCI-sponsored clinical trials that proved the drug’s effectiveness against the disease.

  13. FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | Poster

    Cancer.gov

    By Frank Blanchard, Staff Writer The U.S. Food and Drug Administration (FDA) recently approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected. The National Cancer Institute’s (NCI) Biopharmaceutical Development Program (BDP) at the Frederick National Laboratory for Cancer Research produced ch14.18 for the NCI-sponsored clinical trials that proved the drug’s effectiveness against the disease.

  14. The FDA's program for monitoring radionuclides in food

    SciTech Connect

    Baratta, E.J. )

    1992-01-01

    The US Food and Drug Administration (FDA) modified its food-monitoring program in 1973 to include radioactive isotopes. There was concern at this time about the possibility of food contamination by effluents from nuclear power plants, some above-ground weapons testing by nonsignatory powers, and increased use of medical and commercial radioactive materials. The FDA decided, therefore, that a radioanalytical capability must be maintained to detect any upward trend of radioactive contamination in food. This capability would also allow the FDA to respond to any incidents that might occur in order to protect the US food supply. This program is located at the FDA's Winchester Engineering and Analytical Center, Winchester, Massachusetts.

  15. From off-label prescribing towards a new FDA.

    PubMed

    Tabarrok, Alex

    2009-01-01

    Once a drug has been FDA-permitted for some use it can be prescribed for any use. New uses for old drugs are often discovered so a significant fraction of all prescriptions are for uses which were not tested in the FDA permitting process. The prevalence of 'off-label' prescribing has generated concern that prescribing is not scientifically sound or in the patient interest. A better understanding and appreciation of the off-label system suggests that additional FDA regulation is not warranted but that reform of the FDA towards a Consumer Reports model may substantially benefit patients.

  16. Spin in RCTs of anxiety medication with a positive primary outcome: a comparison of concerns expressed by the US FDA and in the published literature

    PubMed Central

    Beijers, Lian; Jeronimus, Bertus F; Turner, Erick H; de Jonge, Peter; Roest, Annelieke M

    2017-01-01

    Objectives This study aimed to determine the presence of spin in papers on positive randomised clinical trials (RCTs) of antidepressant medication for anxiety disorders by comparing concerns expressed in the Food and Drug Administration (FDA) reviews with those expressed in the published paper. Methods For every positive anxiety medication trial with a matching publication (n=41), two independent reviewers identified the concerns raised in the US FDA reviews and those in the published literature. Spin was identified when concerns or limitations were expressed by the FDA (about the efficacy of the study drug) but not in the corresponding published paper. Concerns mentioned in the papers but not by the FDA were scored as ‘non-FDA’ concerns. Findings Only six out of 35 (17%) of the FDA concerns pertaining to drug efficacy were reported in the papers. Two papers mentioned a concern that fit the FDA categories, but was not mentioned in the corresponding FDA review. Eighty-seven non-FDA concerns were counted, which often reflected general concerns or concerns related to the study design. Conclusions Results indicate the presence of substantial spin in the clinical trial literature on drugs for anxiety disorders. In papers describing RCTs on anxiety medication, the concerns raised by the authors differed from those raised by the FDA. Published papers mentioned a large number of generic concerns about RCTs, such as a lack of long-term research and limited generalisability, while they mentioned few concerns about drug efficacy. These results warrant the promotion of independent statistical review, reporting of patient-level data, more study of spin, and an increased expectation that authors report FDA concerns. PMID:28360236

  17. 75 FR 68009 - Office of New Reactors; Notice of Availability of the Final Staff Guidance Standard Review Plan...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-04

    ...] [FR Doc No: 2010-27873] NUCLEAR REGULATORY COMMISSION [NRC-2010-0228] Office of New Reactors; Notice... Physical Security--Combined License and Operating Reactors AGENCY: Nuclear Regulatory Commission (NRC..., ``Standard Review Plan (SRP) for the Review of Safety Analysis Reports for Nuclear Power Plants,'' Section 13...

  18. Draft guidance for industry; exports and imports under the FDA Export Reform and Enhancement Act of 1996--FDA. Notice.

    PubMed

    1998-06-12

    The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled, "FDA Draft Guidance for Industry on: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996." The draft guidance document addresses issues pertaining to the exportation of human drugs, animal drugs, biologics, food additives, and devices as well as the importation of components, parts, accessories, or other articles for incorporation or further processing into articles intended for export.

  19. Assuring safety of inherently unsafe medications: the FDA risk evaluation and mitigation strategies.

    PubMed

    Nelson, Lewis S; Loh, Meredith; Perrone, Jeanmarie

    2014-06-01

    The decision to approve a drug for clinical use is based on an understanding of its benefits versus the risks. Although efficacy is generally understood at the time of submission to the FDA for approval, the risks are more difficult to assess. Both PubMed (from 2000 to 2012) and the FDA website (www.fda.gov) were searched using the search terms "risk evaluation and mitigation strategy" (REMS). Articles for review were selected by relevance to topic, and their references were searched as well for additional relevant resources. Since the search results were not expected to contain research studies, formal quality assessment and inclusion and exclusion criteria were not utilized resulting in a narrative review. Few directly relevant research studies exist, although supporting documents such as government reports were available. For effective drugs with unclear or concerning safety records, the FDA has the option of requiring a risk evaluation and mitigation strategy, which allows a systematic approach to track and assure safe medication use. Over 100 different medications are currently covered by REMS, and each REMS is developed individually based on the needs of the specific drug or class. Although likely associated with improvements in medication safety, the potential benefit, limitations, and consequences of REMS are not yet fully understood.

  20. Evaluation of hepatic impairment dosing recommendations in FDA-approved product labels.

    PubMed

    Chang, Yang; Burckart, Gilbert J; Lesko, Lawrence J; Dowling, Thomas C

    2013-09-01

    Pharmacokinetic (PK) studies in patients with liver disease are an important clinical pharmacology component of drug development. In 2003, FDA released the guidance for industry on "Pharmacokinetics in Patients with Impaired Hepatic Function," which provides recommendations to sponsors on study design, data analysis, and impact on dosing and labeling. We evaluated the quality and consistency of hepatic dosing recommendations, and compared contemporary clinical practice of dosing in patients with impaired hepatic function with product labels. All new molecular entities (NME) and labels approved by the FDA during the period of January 2004 to December 2011 were reviewed. The fraction of the dose hepatically eliminated, quality of hepatic impairment PK studies reported, and any dose recommendations provided in the label and in a tertiary clinical reference (Micromedex) were reviewed. Out of 157 NMEs, 67 met the criteria for evaluation of dosing in hepatic disease. Problem areas were identified related to the lack of specific hepatic metabolism information in 90% of FDA-approved labels, inconsistent terminology, and "use with caution in liver disease" in 27% of NME. Updating the FDA guidance on PK studies in patients with impaired hepatic function could provide a standardized approach to improve the clinical usefulness of this dosing information for practitioners.

  1. Implementing the Biopharmaceutics Classification System in Drug Development: Reconciling Similarities, Differences, and Shared Challenges in the EMA and US-FDA-Recommended Approaches.

    PubMed

    Cardot, J-M; Garcia Arieta, A; Paixao, P; Tasevska, I; Davit, B

    2016-07-01

    The US-FDA recently posted a draft guideline for industry recommending procedures necessary to obtain a biowaiver for immediate-release oral dosage forms based on the Biopharmaceutics Classification System (BCS). This review compares the present FDA BCS biowaiver approach, with the existing European Medicines Agency (EMA) approach, with an emphasis on similarities, difficulties, and shared challenges. Some specifics of the current EMA BCS guideline are compared with those in the recently published draft US-FDA BCS guideline. In particular, similarities and differences in the EMA versus US-FDA approaches to establishing drug solubility, permeability, dissolution, and formulation suitability for BCS biowaiver are critically reviewed. Several case studies are presented to illustrate the (i) challenges of applying for BCS biowaivers for global registration in the face of differences in the EMA and US-FDA BCS biowaiver criteria, as well as (ii) challenges inherent in applying for BCS class I or III designation and common to both jurisdictions.

  2. Use of surrogate outcomes in US FDA drug approvals, 2003–2012: a survey

    PubMed Central

    Yu, Tsung; Hsu, Yea-Jen; Fain, Kevin M; Boyd, Cynthia M; Holbrook, Janet T; Puhan, Milo A

    2015-01-01

    Objective To evaluate, across a spectrum of diseases, how often surrogate outcomes are used as a basis for drug approvals by the US Food and Drug Administration (FDA), and whether and how the rationale for using treatment effects on surrogates as predictors of treatment effects on patient-centred outcomes is discussed. Study design and setting We used the Drugs@FDA website to identify drug approvals produced from 2003 to 2012 by the FDA. We focused on four diseases (chronic obstructive pulmonary disease (COPD), type 1 or 2 diabetes, glaucoma and osteoporosis) for which surrogates are commonly used in trials. We reviewed the drug labels and medical reviews to provide empirical evidence on how surrogate outcomes are handled by the FDA. Results Of 1043 approvals screened, 58 (6%) were for the four diseases of interest. Most drugs for COPD (7/9, 78%), diabetes (26/26, 100%) and glaucoma (9/9, 100%) were approved based on surrogates while for osteoporosis, most drugs (10/14, 71%) were also approved for patient-centred outcomes (fractures). The rationale for using surrogates was discussed in 11 of the 43 (26%) drug approvals based on surrogates. In these drug approvals, we found drug approvals for diabetes are more likely than the other examined conditions to contain a discussion of trial evidence demonstrating that treatment effects on surrogate outcomes predict treatment effects on patient-centred outcomes. Conclusions Our results suggest that the FDA did not use a consistent approach to address surrogates in assessing the benefits and harms of drugs for COPD, type 1 or 2 diabetes, glaucoma and osteoporosis. For evaluating new drugs, patient-centred outcomes should be chosen whenever possible. If the use of surrogate outcomes is necessary, then a consistent approach is important to review the evidence for surrogacy and consider surrogate's usage in the treatment and population under study. PMID:26614616

  3. A pilot study of "post-seclusion and/or restraint review" intervention with patients and staff in a mental health setting.

    PubMed

    Goulet, Marie-Hélène; Larue, Caroline; Lemieux, Ashley J

    2017-06-20

    To develop and evaluate a "post-seclusion and/or restraint review" (PSRR) intervention implemented in an acute psychiatric care unit. Twelve staff members and three patients were enrolled in a participatory case study. To evaluate PSRR intervention, qualitative analysis was carried out. Seclusion and restraint use 6 months before and after the PSRR implementation was compared. Nurses reported that they were able to explore the patient's feelings during the PSRR intervention with patients, which led to restoration of the therapeutic relationship. PSRR with the treatment team was perceived as a learning opportunity, which allowed to improve the therapeutic intervention. Both the use of seclusion and the time spent in seclusion were significantly reduced 6 months after the implementation of PSRR intervention. Our results suggest the efficacy of PSRR in overcoming the discomfort perceived by both staff and patient and, in the meantime, in reducing the need for coercive procedures. Systematic PSRR could permit to improve the quality of care and the safety of aggressiveness management. © 2017 Wiley Periodicals, Inc.

  4. FDA Warns Diabetics Against Use of Secondhand Test Strips

    MedlinePlus

    ... not have been cleared by the FDA for sale in the United States. Signs of unsafe strips include instructions that aren't in English or strips that look different than other strips of the same brand. The FDA recommends buying new, unopened vials of glucose test strips designed specifically ...

  5. 36 CFR 13.980 - Other FDA closures and restrictions.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 36 Parks, Forests, and Public Property 1 2014-07-01 2014-07-01 false Other FDA closures and restrictions. 13.980 Section 13.980 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF... center and on the park Web site. Violating FDA closures or restrictions is prohibited. ...

  6. 36 CFR 13.980 - Other FDA closures and restrictions.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 36 Parks, Forests, and Public Property 1 2010-07-01 2010-07-01 false Other FDA closures and restrictions. 13.980 Section 13.980 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF... center and on the park Web site. Violating FDA closures or restrictions is prohibited. ...

  7. 36 CFR 13.980 - Other FDA closures and restrictions.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 36 Parks, Forests, and Public Property 1 2012-07-01 2012-07-01 false Other FDA closures and restrictions. 13.980 Section 13.980 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF... center and on the park Web site. Violating FDA closures or restrictions is prohibited. ...

  8. 36 CFR 13.980 - Other FDA closures and restrictions.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 36 Parks, Forests, and Public Property 1 2011-07-01 2011-07-01 false Other FDA closures and restrictions. 13.980 Section 13.980 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF... center and on the park Web site. Violating FDA closures or restrictions is prohibited. ...

  9. 21 CFR 5.1110 - FDA public information offices.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA public information offices. 5.1110 Section 5.1110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ORGANIZATION Organization § 5.1110 FDA public information offices. (a) Division of Dockets Management....

  10. Review on colonization of residents and staff in Italian long-term care facilities by multidrug-resistant bacteria compared with other European countries.

    PubMed

    Aschbacher, Richard; Pagani, Elisabetta; Confalonieri, Massimo; Farina, Claudio; Fazii, Paolo; Luzzaro, Francesco; Montanera, Pier Giorgio; Piazza, Aurora; Pagani, Laura

    2016-01-01

    Rates of colonization and infection with multidrug-resistant (MDR) bacteria are increasing worldwide, in both acute care hospitals and long-term care facilities (LTCFs). Italy has one of the highest prevalence of MDR bacteria in European countries, especially with regard to methicillin-resistant Staphylococcus aureus (MRSA) and extended-spectrum β-lactamase (ESBL) or carbapenemase producing Enterobacteriaceae (CPE). Review of studies on colonization by MDR bacteria from Italian LTCFs, risk factors for colonization and molecular characteristics of surveillance and clinical isolates, compared with other European countries. High variability of MDR colonization has been reported within and especially between European countries. Only a few surveillance studies have been performed in Italian LTCFs; these show MRSA colonization prevalence of 7.8-38.7 % for residents and 5.2-7.0 % for staff members, ESBL prevalence of 49.0-64.0 % for residents and 5.2-14.5 % for staff and prevalence of CPE of 1.0-6.3 % for residents and 0.0-1.5 % for staff. In Italian LTCFs, as well as in other European countries, the most prevalent ESBLs from surveillance or clinical Escherichia coli isolates were found to be CTX-M-type enzymes, particularly CTX-M-15, expressed by the pandemic ST131 clonal group; this lineage also expresses carbapenemase genes of the blaVIM and blaKPC types. Various risk factors for colonization of residents by MDR bacteria were identified. The limited data from Italian LTCFs confirms these settings as important reservoirs for MDR organisms, allowing important considerations regarding the infection risk by these organisms. Nevertheless, more extended and countrywide screening studies for MDR colonization in Italian LTCFs are required. To promote further studies of various microbiological aspects related to LTCFs, the Association of Italian Clinical Microbiologists (Associazione Microbiologi Clinici Italiani; AMCLI) in 2016 has set up a new Working Group for the

  11. THERACOM: a systematic review of the evidence base for interventions to improve Therapeutic Communications between black and minority ethnic populations and staff in specialist mental health services

    PubMed Central

    2013-01-01

    Background Black and Minority Ethnic (BME) groups in receipt of specialist mental health care have reported higher rates of detention under the mental health act, less use of psychological therapies, and more dissatisfaction. Although many explanations have been put forward to explain this, a failure of therapeutic communications may explain poorer satisfaction, disengagement from services and ethnic variations in access to less coercive care. Interventions that improve therapeutic communications may offer new approaches to tackle ethnic inequalities in experiences and outcomes. Methods The THERACOM project is an HTA-funded evidence synthesis review of interventions to improve therapeutic communications between black and minority ethnic patients in contact with specialist mental health services and staff providing those services. This article sets out the protocol methods for a necessarily broad review topic, including appropriate search strategies, dilemmas for classifying different types of therapeutic communications and expectations of the types of interventions to improve them. The review methods will accommodate unexpected types of study and interventions. The findings will be reported in 2013, including a synthesis of the quantitative and grey literature. Discussion A particular methodological challenge is to identify and rate the quality of many different study types, for example, randomised controlled trials, observational quantitative studies, qualitative studies and case studies, which comprise the full range of hierarchies of evidence. We discuss the preliminary methodological challenges and some solutions. (PROSPERO registration number: CRD42011001661). PMID:23442299

  12. 78 FR 15955 - Draft Guidance for Industry and Review Staff on Formal Dispute Resolution: Appeals Above the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ... review, CDER and CBER make a wide variety of scientific and procedural decisions that are critical to a... be precedent setting, it is critical that there be procedures in place to encourage open, prompt... represent the Agency's current thinking on formal dispute resolution regarding appeals above the...

  13. 76 FR 58846 - Final Interim Staff Guidance: Review of Evaluation To Address Gas Accumulation Issues in Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-22

    ....gov . FOR FURTHER INFORMATION CONTACT: Mr. Joseph E. Donoghue, Chief, Reactor Systems, Nuclear Performance and Code Review Branch, Division of Safety Systems & Risk Assessment, U.S. Nuclear Regulatory... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY...

  14. Staff Development for the Continuing Education Staff.

    ERIC Educational Resources Information Center

    Hentschel, Doe

    1990-01-01

    Advocating development for all continuing education staff, the author asserts that staff who understand adult education theory, the goals and visions of the organization, the environmental context of continuing education, and the roles of other staff members will be more effective. Also essential are support mechanisms that facilitate change. (SK)

  15. Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference.

    PubMed

    Yu, Lawrence X; Baker, Jeffrey; Berlam, Susan C; Boam, Ashley; Brandreth, E J; Buhse, Lucinda; Cosgrove, Thomas; Doleski, David; Ensor, Lynne; Famulare, Joseph; Ganapathy, Mohan; Grampp, Gustavo; Hussong, David; Iser, Robert; Johnston, Gordon; Kesisoglou, Filippos; Khan, Mansoor; Kozlowski, Steven; Lacana, Emanuela; Lee, Sau L; Miller, Stephen; Miksinski, Sarah Pope; Moore, Christine M V; Mullin, Theresa; Raju, G K; Raw, Andre; Rosencrance, Susan; Rosolowsky, Mark; Stinavage, Paul; Thomas, Hayden; Wesdyk, Russell; Windisch, Joerg; Vaithiyalingam, Sivakumar

    2015-07-01

    On September 16 and 17, 2014, the Food and Drug Administration (FDA) and Product Quality Research Institute (PQRI) inaugurated their Conference on Evolving Product Quality. The Conference is conceived as an annual forum in which scientists from regulatory agencies, industry, and academia may exchange viewpoints and work together to advance pharmaceutical quality. This Conference Summary Report highlights key topics of this conference, including (1) risk-based approaches to pharmaceutical development, manufacturing, regulatory assessment, and post-approval changes; (2) FDA-proposed quality metrics for products, facilities, and quality management systems; (3) performance-based quality assessment and clinically relevant specifications; (4) recent developments and implementation of continuous manufacturing processes, question-based review, and European Medicines Agency (EMA)-FDA pilot for Quality-by-Design (QbD) applications; and (5) breakthrough therapies, biosimilars, and international harmonization, focusing on ICH M7 and Q3D guidelines. The second FDA/PQRI conference on advancing product quality is planned for October 5-7, 2015.

  16. Existing FDA pathways have potential to ensure early access to, and appropriate use of, specialty drugs.

    PubMed

    Kesselheim, Aaron S; Tan, Yongtian Tina; Darrow, Jonathan J; Avorn, Jerry

    2014-10-01

    Specialty drugs are notable among prescription drugs in that they offer the possibility of substantial clinical improvement, come with important risks of adverse events and mortality, can be complex to manufacture or administer, and are usually extremely costly. The Food and Drug Administration (FDA) plays a critical role in ensuring that patients who could benefit from specialty drugs have access to them in a timely fashion. In this article we review the different strategies that the FDA can use to approve and influence the post-approval prescribing of specialty drugs. When specialty drugs show promise in early clinical trials, the FDA can expedite the drugs' availability to patients through expanded access programs and expedited approval pathways that speed regulatory authorization. After approval, to ensure that specialty drugs are directed to the patients who are most likely to benefit from them, the FDA can limit the scope of the drugs' indications, encourage the development of companion diagnostic tests to indicate which patients should receive the drugs, or require that manufacturers subject them to Risk Evaluation and Mitigation Strategies to ensure that their use is appropriately limited to a restricted population that is aware of the drugs' risks and benefits. Implementing these existing regulatory approaches can promote timely patient access to specialty drugs while preventing expensive and potentially inappropriate overuse.

  17. Extending FDA guidance to include consumer medication information (CMI) delivery on mobile devices.

    PubMed

    Sage, Adam; Blalock, Susan J; Carpenter, Delesha

    This paper describes the current state of consumer-focused mobile health application use and the current U.S. Food and Drug Administration (FDA) guidance on the distribution of consumer medication information (CMI), and discusses recommendations and considerations for the FDA to expand CMI guidance to include CMI in mobile applications. Smartphone-based health interventions have been linked to increased medication adherence and improved health outcomes. Trends in smartphone ownership present opportunities to more effectively communicate and disseminate medication information; however, current FDA guidance for CMI does not outline how to effectively communicate CMI on a mobile platform, particularly in regards to user-centered design and information sourcing. As evidence supporting the potential effectiveness of mobile communication in health care continues to increase, CMI developers, regulating entities, and researchers should take note. Although mobile-based CMI offers an innovative mechanism to deliver medication information, caution should be exercised. Specifically, considerations for developing mobile CMI include consumers' digital literacy, user experience (e.g., usability), and the quality and accuracy of new widely used sources of information (e.g., crowd-sourced reviews and ratings). Recommended changes to FDA guidance for CMI include altering the language about scientific accuracy to address more novel methods of information gathering (e.g., anecdotal experiences and Google Consumer Surveys) and including guidance for usability testing of mobile health applications. Copyright © 2016 Elsevier Inc. All rights reserved.

  18. The US FDA and animal cloning: risk and regulatory approach.

    PubMed

    Rudenko, Larisa; Matheson, John C

    2007-01-01

    The Food and Drug Administration's (FDA's) Center for Veterinary Medicine issued a voluntary request to producers of livestock clones not to introduce food from clones or their progeny into commerce until the agency had assessed whether production of cattle, swine, sheep, or goats by somatic cell nuclear transfer (SCNT) posed any unique risks to the animal(s) involved in the process, humans, or other animals by consuming food from those animals, compared with any other assisted reproductive technology (ART) currently in use. Following a comprehensive review, no anomalies were observed in animals produced by cloning that have not also been observed in animals produced by other ARTs and natural mating. Further systematic review on the health of, and composition of meat and milk from, cattle, swine, and goat clones and the progeny of cattle and sheep did not result in the identification of any food-consumption hazards. The agency therefore concluded that food from cattle, swine, and goat clones was as safe to eat as food from animals of those species derived by conventional means. The agency also concluded that food from the progeny of the clone of any species normally consumed for food is as safe to eat as those animals. The article also describes the methodology used by the agency to analyze data and draw these conclusions, the plans the agency has proposed to manage any identified risks, and the risk communication approaches the agency has used.

  19. 76 FR 31615 - Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-01

    ... sponsor of a clinical investigation that uses such an IVD product in a study. The manufacturer of such an... as the marketing is only for investigational use. The marketing of unapproved and uncleared IVD...

  20. 78 FR 36194 - Draft Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-17

    ... New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood..., Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic... Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications...

  1. Current FDA-approved treatments for Helicobacter pylori and the FDA approval process.

    PubMed

    Hopkins, R J

    1997-12-01

    U.S. Food and Drug Administration (FDA) approval of new drugs expands treatment options and serves as a "safety net" of well-documented efficacy and safety. The information provided in the package insert facilitates physician education and provides some assurance that marketing information is accurate. As of February 1997, three Helicobacter pylori regimes have been FDA-approved for eradication of H. pylori in infected patients with active duodenal ulcers. Regimen 1, omeprazole + clarithromycin (O/C), was supported by two multicenter, controlled studies with a 6-month follow-up. Eradication rates were 74% (n = 53; 95% confidence interval [CI], 62-85) and 64% (n = 61; 95% CI, 52-76). Twenty-five of 26 patients with failed eradication therapy who were taking O/C with clarithromycin-susceptible strains before treatment and who had pretreatment and posttreatment susceptibility tests performed developed clarithromycin resistance after treatment. Regimen 2, ranitidine-bismuth-citrate + clarithromycin, was supported by two multicenter, placebo-controlled studies with a 6-month follow-up. Eradication rates were 84% (n = 19; 95% CI, 60-96) and 73% (n = 22; 95% CI, 50-88). Insufficient pretreatment and posttreatment susceptibility data were collected to assess antimicrobial resistance. Regimen 3, bismuth subsalicylate + metronidazole + tetracycline + an H2-receptor antagonist, was supported by two pivotal literature-based studies. Eradication rates in patients with duodenal ulcer were 82% (n = 51; 95% CI, 70-92) and 77% (n = 39; 95% CI, 61-89), respectively. When extrapolating the results of these three FDA-approved regimens to the clinical setting, particular aspects of the clinical trial should be kept in mind. These include the type of controls, primary end points used, population studied, and number and type of dropouts.

  2. Effectiveness of structured multidisciplinary rounding in acute care units on length of stay and satisfaction of patients and staff: a quantitative systematic review.

    PubMed

    Mercedes, Angela; Fairman, Precillia; Hogan, Lisa; Thomas, Rexi; Slyer, Jason T

    2016-07-01

    Consistent, concise and timely communication between a multidisciplinary team of healthcare providers, patients and families is necessary for the delivery of quality care. Structured multidisciplinary rounding (MDR) using a structured communication tool may positively impact length of stay (LOS) and satisfaction of patients and staff by improving communication, coordination and collaboration among the healthcare team. To evaluate the effectiveness of structured MDR using a structured communication tool in acute care units on LOS and satisfaction of patients and staff. Adult patients admitted to acute care units and healthcare providers who provide direct care for adult patients hospitalized in in-patient acute care units. The implementation of structured MDR utilizing a structured communication tool to enhance and/or guide communication. Quasi-experimental studies and descriptive studies. Length of stay, patient satisfaction and staff satisfaction. The comprehensive search strategy aimed to find relevant published and unpublished quantitative English language studies from the inception of each database searched through June 30, 2015. Databases searched include Cumulative Index to Nursing and Allied Health Literature, PubMed, Excerpta Medica Database, Health Source, Cochrane Central Register of Controlled Trials and Scopus. A search of gray literature was also performed. All reviewers independently evaluated the included studies for methodological quality using critical appraisal tools from the Joanna Briggs Institute (JBI). Data related to the methods, participants, interventions and findings were extracted using a standardized data extraction tool from the JBI. Due to clinical and methodological heterogeneity in the interventions and outcome measures of the included studies, statistical meta-analysis was not possible. Results are presented in narrative form. Eight studies were included, three quasi-experimental studies and five descriptive studies of quality

  3. Impact of FDA guidance for developing diabetes drugs on trial design: from policy to practice.

    PubMed

    Bethel, M Angelyn; Sourij, Harald

    2012-02-01

    In 2008, the US Food and Drug Administration (FDA) issued guidance requiring robust assessment of cardiovascular safety for all antidiabetic drugs to be licensed in the future. Here, we review the circumstances giving rise to the FDA guidance and describe the characteristics of clinical trials registered on ClinicalTrials.gov in the 36 months before and after the guidance was issued. We noted a doubling in the number of cardiovascular outcome trials registered and a sixfold increase in the median number of patients included in cardiovascular outcome trials in the latter 36 months. As the size and duration of follow-up for these trials increases, the clinical trials industry will need to adapt. The present review summarizes current attempts to streamline trial design and management to meet the requirements efficiently while adhering to the highest scientific standards.

  4. Inspection of computer-supported toxicological data submitted to the FDA.

    PubMed

    Taylor, D W

    1984-01-01

    The FDA's Good Laboratory Practice Regulations (GLP) have been formally amended (once) and two formed advisory opinions have been issued. The FDA is now in the process of reviewing the GLPs to comply with both the Regulatory Flexibility Act of 1980 and Executive Order 12291 of 1981. Inspections since 1979 have revealed compliance progress; however, certain areas of the GLPs have been a problem--the definition of "raw data," the documentation process for the maintenance of "raw data," standard operating procedures, and study protocols. The increasing use of computers for supporting toxicology/pathology studies raises several questions concerning the impact of the GLPs on computerized data collection/reporting. This paper will address the above questions and discuss systems, procedures, interpretations, and some unresolved problems, as well as provide practical approaches for internal review of computer-supported nonclinical laboratory studies.

  5. FDA, CE mark or something else?-Thinking fast and slow.

    PubMed

    Mishra, Sundeep

    There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own problems. Historically, the Japanese review process has tended to be the slowest among the big three but recently with the introduction of accelerated review process there has been a significant progress. While the goal of an innovator/manufacturer is to develop, manufacture and market a medical device that addresses an unmet clinical need, the requisite regulatory approval process can be very confusing. Not only there is a whole lot of jargon tossed around by regulatory affair professionals: "substantial equivalence," "PMDA," "CE mark," "Notified body," "510K" and "PMA" but the actual approval process can also be very tardy, inconsistent and expensive.

  6. Staff meeting

    ScienceCinema

    None

    2016-07-12

    I would like to invite all members of the CERN Personnel to a meeting on Wednesday 16 January 2008 at 3:00 p.m. Main Auditorium (bldg 500) to convey my best wishes for the new year, to review CERN’s activities during 2007 and to present the perspectives for 2008, the year of the LHC start-up. Closed-circuit transmission of the meeting will be available in the Council Chamber and in the AB Auditorium (Meyrin), the AB Auditorium (Prévessin), the IT Auditorium (Bldg. 31) and the AT Auditorium (Bldg. 30). Simultaneous translation into English will be available in the main Auditorium. Best wishes for the festive season! Robert AYMAR

  7. FDA perspective: enrolment of elderly transplant recipients in clinical trials.

    PubMed

    Meyer, Joette M; Archdeacon, Patrick; Albrecht, Renata

    2013-04-15

    Since 1989, the U.S. Food and Drug Administration (FDA) has encouraged the study of new drug and therapeutic products in elderly patients. However, despite the aging population in the United States, elderly patients continue to be underrepresented in clinical trials across a variety of therapeutic areas, including transplantation. The currently available tools for the FDA to encourage and require the evaluation and reporting of safety and efficacy information in elderly patients are summarized. Clinicians, sponsors, and investigators are encouraged to work with the FDA to expand the enrolment of elderly patients in clinical trials of transplantation.

  8. Update on medical and regulatory issues pertaining to compounded and FDA-approved drugs, including hormone therapy

    PubMed Central

    Pinkerton, JoAnn V.; Pickar, James H.

    2016-01-01

    Abstract Objective: We review the historical regulation of drug compounding, concerns about widespread use of non-Food and Drug Admiistration (FDA)-approved compounded bioidentical hormone therapies (CBHTs), which do not have proper labeling and warnings, and anticipated impact of the 2013 Drug Quality and Security Act (DQSA) on compounding. Methods: US government websites were searched for documents concerning drug compounding regulation and oversight from 1938 (passage of Federal Food, Drug, and Cosmetic Act [FDCA]) through 2014, including chronologies, Congressional testimony, FDA guidelines and enforcements, and reports. The FDCA and DQSA were reviewed. PubMed and Google were searched for articles on compounded drugs, including CBHT. Results: Congress explicitly granted the FDA limited oversight of compounded drugs in a 1997 amendment to the FDCA, but the FDA has encountered obstacles in exercising that authority. After 64 patient deaths and 750 adversely affected patients from the 2012 meningitis outbreak due to contaminated compounded steroid injections, Congress passed the DQSA, authorizing the FDA to create a voluntary registration for facilities that manufacture and distribute sterile compounded drugs in bulk and reinforcing FDCA regulations for traditional compounding. Given history and current environment, concerns remain about CBHT product regulation and their lack of safety and efficacy data. Conclusions: The DQSA and its reinforcement of §503A of the FDCA solidifies FDA authority to enforce FDCA provisions against compounders of CBHT. The new law may improve compliance and accreditation by the compounding industry; support state and FDA oversight; and prevent the distribution of misbranded, adulterated, or inconsistently compounded medications, and false and misleading claims, thus reducing public health risk. PMID:26418479

  9. ClinicalTrials.gov and Drugs@FDA: A Comparison of Results Reporting for New Drug Approval Trials.

    PubMed

    Schwartz, Lisa M; Woloshin, Steven; Zheng, Eugene; Tse, Tony; Zarin, Deborah A

    2016-09-20

    Pharmaceutical companies and other trial sponsors must submit certain trial results to ClinicalTrials.gov. The validity of these results is unclear. To validate results posted on ClinicalTrials.gov against publicly available U.S. Food and Drug Administration (FDA) reviews on Drugs@FDA. ClinicalTrials.gov (registry and results database) and Drugs@FDA (medical and statistical reviews). 100 parallel-group, randomized trials for new drug approvals (January 2013 to July 2014) with results posted on ClinicalTrials.gov (15 March 2015). 2 assessors extracted, and another verified, the trial design, primary and secondary outcomes, adverse events, and deaths. Most trials were phase 3 (90%), double-blind (92%), and placebo-controlled (73%) and involved 32 drugs from 24 companies. Of 137 primary outcomes identified from ClinicalTrials.gov, 134 (98%) had corresponding data at Drugs@FDA, 130 (95%) had concordant definitions, and 107 (78%) had concordant results. Most differences were nominal (that is, relative difference <10%). Primary outcome results in 14 trials could not be validated. Of 1927 secondary outcomes from ClinicalTrials.gov, Drugs@FDA mentioned 1061 (55%) and included results data for 367 (19%). Of 96 trials with 1 or more serious adverse events in either source, 14 could be compared and 7 had discordant numbers of persons experiencing the adverse events. Of 62 trials with 1 or more deaths in either source, 25 could be compared and 17 were discordant. Unknown generalizability to uncontrolled or crossover trial results. Primary outcome definitions and results were largely concordant between ClinicalTrials.gov and Drugs@FDA. Half the secondary outcomes, as well as serious events and deaths, could not be validated because Drugs@FDA includes only "key outcomes" for regulatory decision making and frequently includes only adverse event results aggregated across multiple trials. National Library of Medicine.

  10. ClinicalTrials.gov and Drugs@FDA: A comparison of results reporting for new drug approval trials

    PubMed Central

    Schwartz, Lisa M.; Woloshin, Steven; Zheng, Eugene; Tse, Tony; Zarin, Deborah A.

    2016-01-01

    Background Pharmaceutical companies and other trial sponsors must submit certain trial results to ClinicalTrials.gov. The validity of these results is unclear. Purpose To validate results posted on ClinicalTrials.gov against publicly-available FDA reviews on Drugs@FDA. Data sources ClinicalTrials.gov (registry and results database) and Drugs@FDA (medical/statistical reviews). Study selection 100 parallel-group, randomized trials for new drug approvals (1/2013 – 7/2014) with results posted on ClinicalTrials.gov (3/15/2015). Data extraction Two assessors systematically extracted, and another verified, trial design, primary/secondary outcomes, adverse events, and deaths. Results The 100 trials were mostly phase 3 (90%) double-blind (92%), placebo-controlled (73%), representing 32 drugs from 24 companies. Of 137 primary outcomes from ClinicalTrials.gov, 134 (98%) had corresponding data in Drugs@FDA, 130 (95%) had concordant definitions, and 107 (78%) had concordant results; most differences were nominal (i.e. relative difference < 10%). Of 100 trials, primary outcome results in 14 could not be validated . Of 1,927 secondary outcomes from ClinicalTrials.gov, 1,061 (55%) definitions could be validated and 367 (19%) had results. Of 96 trials with ≥ 1 serious adverse event in either source, 14 could be compared and 7 were discordant. Of 62 trials with ≥ 1 death in either source, 25 could be compared and 17 were discordant. Limitations Unknown generalizability to uncontrolled or crossover trial results. Conclusion Primary outcome definitions and results were largely concordant between ClinicalTrials.gov and Drugs@FDA. Half of secondary outcomes could not be validated because Drugs@FDA only includes “key outcomes” for regulatory decision-making; nor could serious adverse events and deaths because Drugs@FDA frequently only includes results aggregated across multiple trials. PMID:27294570

  11. From bench to FDA to bedside: US regulatory trends for new stem cell therapies.

    PubMed

    Knoepfler, Paul S

    2015-03-01

    The phrase "bench-to-bedside" is commonly used to describe the translation of basic discoveries such as those on stem cells to the clinic for therapeutic use in human patients. However, there is a key intermediate step in between the bench and the bedside involving governmental regulatory oversight such as by the Food and Drug Administration (FDA) in the United States (US). Thus, it might be more accurate in most cases to describe the stem cell biological drug development process in this way: from bench to FDA to bedside. The intermediate development and regulatory stage for stem cell-based biological drugs is a multifactorial, continually evolving part of the process of developing a biological drug such as a stem cell-based regenerative medicine product. In some situations, stem cell-related products may not be classified as biological drugs in which case the FDA plays a relatively minor role. However, this middle stage is generally a major element of the process and is often colloquially referred to in an ominous way as "The Valley of Death". This moniker seems appropriate because it is at this point, and in particular in the work that ensues after Phase 1, clinical trials that most drug product development is terminated, often due to lack of funding, diseases being refractory to treatment, or regulatory issues. Not surprisingly, workarounds to deal with or entirely avoid this difficult stage of the process are evolving both inside and outside the domains of official regulatory authorities. In some cases these efforts involve the FDA invoking new mechanisms of accelerating the bench to beside process, but in other cases these new pathways bypass the FDA in part or entirely. Together these rapidly changing stem cell product development and regulatory pathways raise many scientific, ethical, and medical questions. These emerging trends and their potential consequences are reviewed here.

  12. From Bench to FDA to Bedside: US Regulatory Trends for New Stem Cell Therapies

    PubMed Central

    Knoepfler, Paul S.

    2015-01-01

    The phrase “bench to bedside” is commonly used to describe the translation of basic discoveries such as those on stem cells to the clinic for therapeutic use in human patients. However, there is a key intermediate step in between the bench and the bedside involving governmental regulatory oversight such as by the Food and Drug Administration (FDA) in the United States (US). Thus, it might be more accurate in most cases to describe the stem cell biological drug development process in this way: from bench to FDA to bedside. The intermediate development and regulatory stage for stem cell-based biological drugs is a multifactorial, continually evolving part of the process of developing a biological drug such as a stem cell-based regenerative medicine product. In some situations, stem cell-related products may not be classified as biological drugs in which case the FDA plays a relatively minor role. However, this middle stage is generally a major element of the process and is often colloquially referred to in an ominous way as “The Valley of Death”. This moniker seems appropriate because it is at this point and in particular in the work that ensues after Phase 1 clinical trials that most drug product development is terminated, often due to lack of funding, diseases being refractory to treatment, or regulatory issues. Not surprisingly, workarounds to deal with or entirely avoid this difficult stage of the process are evolving both inside and outside the domains of official regulatory authorities. In some cases these efforts involve the FDA invoking new mechanisms of accelerating the bench to beside process, but in other cases these new pathways bypass the FDA in part or entirely. Together these rapidly changing stem cell product development and regulatory pathways raise many scientific, ethical, and medical questions. These emerging trends and their potential consequences are reviewed here. PMID:25489841

  13. Regulatory perspectives and research activities at the FDA on the use of phantoms with in vivo diagnostic devices

    NASA Astrophysics Data System (ADS)

    Agrawal, Anant; Gavrielides, Marios A.; Weininger, Sandy; Chakrabarti, Kish; Pfefer, Joshua

    2008-02-01

    For a number of years, phantoms have been used to optimize device parameters and validate performance in the primary medical imaging modalities (CT, MRI, PET/SPECT, ultrasound). Furthermore, the FDA under the Mammography Quality Standards Act (MQSA) requires image quality evaluation of mammography systems using FDA-approved phantoms. The oldest quantitative optical diagnostic technology, pulse oximetry, also benefits from the use of active phantoms known as patient simulators to validate certain performance characteristics under different clinically-relevant conditions. As such, guidance provided by the FDA to its staff and to industry on the contents of pre-market notification and approval submissions includes suggestions on how to incorporate the appropriate phantoms in establishing device effectiveness. Research at the FDA supports regulatory statements on the use of phantoms by investigating how phantoms can be designed, characterized, and utilized to determine critical device performance characteristics. These examples provide a model for how novel techniques in the rapidly growing field of optical diagnostics can use phantoms during pre- and post-market regulatory testing.

  14. 75 FR 22601 - Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-29

    ... Staff; User Fees for 513(g); Requests for Information; Availability AGENCY: Food and Drug Administration... the draft guidance entitled ``Draft Guidance for Industry and FDA Staff; User Fees for 513(g) Requests for Information.'' This draft guidance describes the user fees associated with 513(g) requests for...

  15. FDA Approves New Drug for Sickle Cell Disease

    MedlinePlus

    ... medlineplus.gov/news/fullstory_167075.html FDA Approves New Drug for Sickle Cell Disease Helps reduce painful, ... and Drug Administration on Friday approved the first new drug for sickle cell disease in nearly two ...

  16. FDA Bacteriological Analytical Manual, Chapter 10, 2003: Listeria monocytogenes

    EPA Pesticide Factsheets

    FDA Bacteriological Analytical Manual, Chapter 10 describes procedures for analysis of food samples and may be adapted for assessment of solid, particulate, aerosol, liquid and water samples containing Listeria monocytogenes.

  17. What FDA Learned About Dark Chocolate and Milk Allergies

    MedlinePlus

    ... For Consumers Consumer Updates What FDA Learned About Dark Chocolate and Milk Allergies Share Tweet Linkedin Pin it ... firm. back to top Milk Detected in Individual Dark Chocolate Products Label/Package Statement Total number of dark ...

  18. FDA Throws Cold Water on Whole Body Cryotherapy

    MedlinePlus

    ... fullstory_163907.html FDA Throws Cold Water on Whole Body Cryotherapy Exposure to ultra-low temperatures shows no benefits ... There's no evidence that a growing trend called whole body cryotherapy is effective, but it does pose a number ...

  19. FDA Issues Anesthesia Warning for Pregnant Women, Kids Under 3

    MedlinePlus

    ... gov/news/fullstory_162543.html FDA Issues Anesthesia Warning for Pregnant Women, Kids Under 3 A long ... latest published studies, the agency announced that these warnings need to be added to the labels of ...

  20. FDA Encourages More Participation, Diversity in Clinical Trials

    MedlinePlus

    ... or older and people from certain racial and ethnic groups. That’s why the FDA is encouraging more ... clinical trials, especially people of different ages, races, ethnic groups, and genders. Read on to learn more ...

  1. America's Porky Pets Face Health Woes, Too, FDA Says

    MedlinePlus

    ... Woes, Too, FDA Says More than half of dogs, cats in the Land of Plenty weigh too ... its pets, with a majority of cats and dogs dangerously overweight, a federal government veterinarian warns. "Just ...

  2. FDA to Weigh Dangers of Exploding E-Cigarettes

    MedlinePlus

    ... FDA had identified 66 instances of e-cigarette explosions in 2015 and early 2016. The batteries overheated, ... that e-cigarettes pose no more fire or explosion risk than other devices that rely on lithium- ...

  3. FDA Approves New Treatment for Dust Mite Allergies

    MedlinePlus

    ... 163882.html FDA Approves New Treatment for Dust Mite Allergies Odactra is a year-round treatment for ... 2017 (HealthDay News) -- A new treatment for dust mite allergies has won approval from the U.S. Food ...

  4. 21 CFR 316.34 - FDA recognition of exclusive approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... exclusive approval. (a) FDA will send the sponsor (or, the permanent-resident agent, if applicable) timely... section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for a designated orphan drug that...

  5. Staff experiences within the implementation of computer-based nursing records in residential aged care facilities: a systematic review and synthesis of qualitative research

    PubMed Central

    2014-01-01

    Background Since the introduction of electronic nursing documentation systems, its implementation in recent years has increased rapidly in Germany. The objectives of such systems are to save time, to improve information handling and to improve quality. To integrate IT in the daily working processes, the employee is the pivotal element. Therefore it is important to understand nurses’ experience with IT implementation. At present the literature shows a lack of understanding exploring staff experiences within the implementation process. Methods A systematic review and meta-ethnographic synthesis of primary studies using qualitative methods was conducted in PubMed, CINAHL, and Cochrane. It adheres to the principles of the PRISMA statement. The studies were original, peer-reviewed articles from 2000 to 2013, focusing on computer-based nursing documentation in Residential Aged Care Facilities. Results The use of IT requires a different form of information processing. Some experience this new form of information processing as a benefit while others do not. The latter find it more difficult to enter data and this result in poor clinical documentation. Improvement in the quality of residents’ records leads to an overall improvement in the quality of care. However, if the quality of those records is poor, some residents do not receive the necessary care. Furthermore, the length of time necessary to complete the documentation is a prominent theme within that process. Those who are more efficient with the electronic documentation demonstrate improved time management. For those who are less efficient with electronic documentation the information processing is perceived as time consuming. Normally, it is possible to experience benefits when using IT, but this depends on either promoting or hindering factors, e.g. ease of use and ability to use it, equipment availability and technical functionality, as well as attitude. Conclusions In summary, the findings showed that members

  6. PREFACE: Fractional Differentiation and its Applications (FDA08) Fractional Differentiation and its Applications (FDA08)

    NASA Astrophysics Data System (ADS)

    Baleanu, Dumitru; Tenreiro Machado, J. A.

    2009-10-01

    The international workshop, Fractional Differentiation and its Applications (FDA08), held at Cankaya University, Ankara, Turkey on 5-7 November 2008, was the third in an ongoing series of conferences dedicated to exploring applications of fractional calculus in science, engineering, economics and finance. Fractional calculus, which deals with derivatives and integrals of any order, is now recognized as playing an important role in modeling multi-scale problems that span a wide range of time or length scales. Fractional calculus provides a natural link to the intermediate-order dynamics that often reflects the complexity of micro- and nanostructures through fractional-order differential equations. Unlike the more established techniques of mathematical physics, the methods of fractional differentiation are still under development; while it is true that the ideas of fractional calculus are as old as the classical integer-order differential operators, modern work is proceeding by both expanding the capabilities of this mathematical tool and by widening its range of applications. Hence, the interested reader will find papers here that focus on the underlying mathematics of fractional calculus, that extend fractional-order operators into new domains, and that apply well established methods to experimental and theoretical problems. The organizing committee invited presentations from experts representing the international community of scholars in fractional calculus and welcomed contributions from the growing number of researchers who are applying fractional differentiation to complex technical problems. The selection of papers in this topical issue of Physica Scripta reflects the success of the FDA08 workshop, with the emergence of a variety of novel areas of application. With these ideas in mind, the guest editors would like to honor the many distinguished scientists that have promoted the development of fractional calculus and, in particular, Professor George M

  7. Subarray-based FDA radar to counteract deceptive ECM signals

    NASA Astrophysics Data System (ADS)

    Abdalla, Ahmed; Wang, Wen-Qin; Yuan, Zhao; Mohamed, Suhad; Bin, Tang

    2016-12-01

    In recent years, the frequency diverse array (FDA) radar concept has attracted extensive attention, as it may benefit from a small frequency increment, compared to the carrier frequency across the array elements and thereby achieve an array factor that is a function of the angle, the time, and the range which is superior to the conventional phase array radar (PAR). However, limited effort on the subject of FDA in electronic countermeasure scenarios, especially in the presence of mainbeam deceptive jamming, has been published. Basic FDA is not desirable for anti-jamming applications, due to the range-angle coupling response of targets. In this paper, a novel method based on subarrayed FDA signal processing is proposed to counteract deceptive ECM signals. We divide the FDA array into multiple subarrays, each of which employs a distinct frequency increment. As a result, in the subarray-based FDA, the desired target can be distinguished at subarray level in joint range-angle-Doppler domain by utilizing the fact that the jammer generates false targets with the same ranges to each subarray without reparations. The performance assessment shows that the proposed solution is effective for deceptive ECM targets suppression. The effectiveness is verified by simulation results.

  8. An FDA bioinformatics tool for microbial genomics research on molecular characterization of bacterial foodborne pathogens using microarrays.

    PubMed

    Fang, Hong; Xu, Joshua; Ding, Don; Jackson, Scott A; Patel, Isha R; Frye, Jonathan G; Zou, Wen; Nayak, Rajesh; Foley, Steven; Chen, James; Su, Zhenqiang; Ye, Yanbin; Turner, Steve; Harris, Steve; Zhou, Guangxu; Cerniglia, Carl; Tong, Weida

    2010-10-07

    Advances in microbial genomics and bioinformatics are offering greater insights into the emergence and spread of foodborne pathogens in outbreak scenarios. The Food and Drug Administration (FDA) has developed a genomics tool, ArrayTrack™, which provides extensive functionalities to manage, analyze, and interpret genomic data for mammalian species. ArrayTrack™ has been widely adopted by the research community and used for pharmacogenomics data review in the FDA's Voluntary Genomics Data Submission program. ArrayTrack™ has been extended to manage and analyze genomics data from bacterial pathogens of human, animal, and food origin. It was populated with bioinformatics data from public databases such as NCBI, Swiss-Prot, KEGG Pathway, and Gene Ontology to facilitate pathogen detection and characterization. ArrayTrack™'s data processing and visualization tools were enhanced with analysis capabilities designed specifically for microbial genomics including flag-based hierarchical clustering analysis (HCA), flag concordance heat maps, and mixed scatter plots. These specific functionalities were evaluated on data generated from a custom Affymetrix array (FDA-ECSG) previously developed within the FDA. The FDA-ECSG array represents 32 complete genomes of Escherichia coli and Shigella. The new functions were also used to analyze microarray data focusing on antimicrobial resistance genes from Salmonella isolates in a poultry production environment using a universal antimicrobial resistance microarray developed by the United States Department of Agriculture (USDA). The application of ArrayTrack™ to different microarray platforms demonstrates its utility in microbial genomics research, and thus will improve the capabilities of the FDA to rapidly identify foodborne bacteria and their genetic traits (e.g., antimicrobial resistance, virulence, etc.) during outbreak investigations. ArrayTrack™ is free to use and available to public, private, and academic researchers at

  9. The ABCs of the FDA: A Primer on the Role of the United States Food and Drug Administration in Medical Device Approvals and IR Research.

    PubMed

    Adamovich, Ashley; Park, Susie; Siskin, Gary P; Englander, Meridith J; Mandato, Kenneth D; Herr, Allen; Keating, Lawrence J

    2015-09-01

    The role of the US Food and Drug Administration (FDA) in medical device regulation is important to device-driven specialties such as interventional radiology. Whether it is through industry-sponsored trials during the approval process for new devices or investigator-initiated research prospectively evaluating the role of existing devices for new or established procedures, interaction with the FDA is an integral part of performing significant research in interventional radiology. This article reviews the potential areas of interface between the FDA and interventional radiology, as understanding these areas is necessary to continue the innovation that is the hallmark of this specialty.

  10. Influencing Variables and Moderators of Transfer of Learning to the Workplace within the Area of Staff Development in Higher Education: Research Review

    ERIC Educational Resources Information Center

    De Rijdt, Catherine; Stes, Ann; van der Vleuten, Cees; Dochy, Filip

    2013-01-01

    The goal of staff development in higher education is a change in teacher practices to positively influence student learning. In other words, the goal of staff development is the transfer of learning to the workplace. Research illuminates that this transfer of learning to the workplace is a complex issue. To make an accurate assessment of staff…

  11. Adding Ebola to the FDA Priority Review Voucher Program Act

    THOMAS, 113th Congress

    Rep. Blackburn, Marsha [R-TN-7

    2014-11-18

    11/21/2014 Referred to the Subcommittee on Health. (All Actions) Notes: For further action, see S.2917, which became Public Law 113-233 on 12/16/2014. Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  12. Adding Ebola to the FDA Priority Review Voucher Program Act

    THOMAS, 113th Congress

    Rep. Blackburn, Marsha [R-TN-7

    2014-11-18

    House - 11/21/2014 Referred to the Subcommittee on Health. (All Actions) Notes: For further action, see S.2917, which became Public Law 113-233 on 12/16/2014. Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  13. Adding Ebola to the FDA Priority Review Voucher Program Act

    THOMAS, 113th Congress

    Rep. Blackburn, Marsha [R-TN-7

    2014-11-18

    11/21/2014 Referred to the Subcommittee on Health. (All Actions) Notes: For further action, see S.2917, which became Public Law 113-233 on 12/16/2014. Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  14. Measuring Staff Turnover in Nursing Homes

    ERIC Educational Resources Information Center

    Castle, Nicholas G.

    2006-01-01

    Purpose: In this study the levels of staff turnover reported in the nursing home literature (1990-2003) are reviewed, as well as the definitions of turnover used in these prior studies. With the use of primary data collected from 354 facilities, the study addresses the various degrees of bias that result, depending on how staff turnover is defined…

  15. Measuring Staff Turnover in Nursing Homes

    ERIC Educational Resources Information Center

    Castle, Nicholas G.

    2006-01-01

    Purpose: In this study the levels of staff turnover reported in the nursing home literature (1990-2003) are reviewed, as well as the definitions of turnover used in these prior studies. With the use of primary data collected from 354 facilities, the study addresses the various degrees of bias that result, depending on how staff turnover is defined…

  16. Accident Prevention: Keeping Campers and Staff Safe.

    ERIC Educational Resources Information Center

    Lebenger, Seymour S.

    1997-01-01

    Strategies for risk assessment and accident prevention include supervising unstructured camper time; assessing games for potential dangers; examining facilities and special programs, including reviewing and evaluating safety and accident reports; and increasing staff awareness by discussing accidents at weekly staff meetings and generating ideas…

  17. FDA & digital mammography: why has FDA required full field digital mammography systems to be regulated as potentially dangerous devices for more than 10 years?

    PubMed

    Nields, Morgan W

    2010-05-01

    Digital mammography is routinely used in the US to screen asymptomatic women for breast cancer and currently over 50% of US screening centers employ the technology. In spite of FDAs knowledge that digital mammography requires less radiation than film mammography and that its equivalence has been proven in a prospective randomized trial, the agency has failed to allow the technology market access via the 510(k) pre market clearance pathway. As a result of the restrictive Pre Market Approval process, only four suppliers have received FDA approval. The resulting lack of a competitive market has kept costs high, restricted technological innovation, and impeded product improvements as a result of PMA requirements. Meanwhile, at least twelve companies are on the market in the EU and the resulting competitive market has lowered costs and provided increased technological choice. A cultural change with new leadership occurred in the early 90's at FDA. The historical culture at the Center for Devices and Radiological Health of collaboration and education gave way to one characterized by a lack of reliance on outside scientific expertise, tolerance of decision making by unqualified reviewers, and an emphasis on enforcement and punishment. Digital mammography fell victim to this cultural change and as a result major innovations like breast CT and computer aided detection technologies are also withheld from the market. The medical device law, currently under review by the Institute of Medicine, should be amended by the Congress so that new technologies can be appropriately classified in accordance with the risk based assessment classification system detailed in Chapter V of the Federal Food, Drug, and Cosmetic Act. A panel of scientific experts chartered by the NIH or IOM should determine the classification appropriate for new technologies that have no historical regulatory framework. This would be binding on FDA. Unless the law is changed we will likely again experience

  18. FDA adverse Event Problem Codes: standardizing the classification of device and patient problems associated with medical device use.

    PubMed

    Reed, Terrie L; Kaufman-Rivi, Diana

    2010-01-01

    The broad array of medical devices and the potential for device failures, malfunctions, and other adverse events associated with each device creates a challenge for public health device surveillance programs. Coding reported events by type of device problem provides one method for identifying a potential signal of a larger device issue. The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) Event Problem Codes that are used to report adverse events previously lacked a structured set of controls for code development and maintenance. Over time this led to inconsistent, ambiguous, and duplicative concepts being added to the code set on an ad-hoc basis. Recognizing the limitation of its coding system the FDA set out to update the system to improve its usefulness within FDA and as a basis of a global standard to identify important patient and device outcomes throughout the medical community. In 2004, FDA and the National Cancer Institute (NCI) signed a Memorandum of Understanding (MOU) whereby NCI agreed to provide terminology development and maintenance services to all FDA Centers. Under this MOU, CDRH's Office of Surveillance and Biometrics (OSB) convened a cross-Center workgroup and collaborated with staff at NCI Enterprise Vocabulary Service (EVS) to streamline the Patient and Device Problem Codes and integrate them into the NCI Thesaurus and Meta-Thesaurus. This initiative included many enhancements to the Event Problem Codes aimed at improving code selection as well as improving adverse event report analysis. LIMITATIONS & RECOMMENDATIONS: Staff resources, database concerns, and limited collaboration with external groups in the initial phases of the project are discussed. Adverse events associated with medical device use can be better understood when they are reported using a consistent and well-defined code set. This FDA initiative was an attempt to improve the structure and add control mechanisms to an existing code set

  19. A comprehensive systematic review of the use of simulation in the continuing education and training of qualified medical, nursing and midwifery staff.

    PubMed

    Elliott, Sharon; Murrell, Karen; Harper, Peter; Stephens, Tim; Pellowe, Carol

    2011-01-01

    Simulation can be defined as a person, device or set of conditions made to resemble a real life situation. It is used in many high-risk industries particularly when reality is dangerous, critical events are rare and errors are costly in human and/or financial terms. The use of simulation in the UK is now considered an essential component of education programmes designed for healthcare practitioners. However the use of simulation in undergraduate education has been studied in depth but little is known about its use in postgraduate education. The aim of this systematic review was to establish: where and in which context is simulation an effective educational medium in post qualifying/continuing education; what is the benefit to learners of using simulation in respect of their knowledge, skills and confidence and what are the implications for future research in this area? This review looked for both quantitative and qualitative evidence in the form of primary research.The review focused on post qualification medical, nursing and midwifery staff undertaking educational development programmes utilising simulation. Types of interventions: the intervention explored in this review is simulation in the form of the re-creation of a patient centred scenario / event in a realistic context. The review explicitly excluded simulation designed to specifically to improve motor skills in isolation from context, such as part task trainers. The outcome measures to be explored in this review were: demonstration of the application of knowledge to the simulated clinical situation; demonstrable improvement in knowledge of the environment and equipment; demonstration of risk assessment; safe working practice in relation to the clinical environment; recognition of own limitations and knowing when to call for help; effective communication; team working and leadership skills; evidence from learners in relation to the educational experience; evidence of increased learner confidence following

  20. 21 CFR 1.379 - How long may FDA detain an article of food?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false How long may FDA detain an article of food? 1.379... Provisions § 1.379 How long may FDA detain an article of food? (a) FDA may detain an article of food for a... institute a seizure or injunction action. The authorized FDA representative may approve the additional...

  1. 21 CFR 1.393 - What information must FDA include in the detention order?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What information must FDA include in the detention... Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order? (a) FDA must issue the detention order in writing, in the form of a detention notice, signed...

  2. Directions in Staff Development

    ERIC Educational Resources Information Center

    Brew, Angela, Ed.

    This collection of readings is intended to provide a source book on best practices in staff development in higher education within a British context. The 13 papers are grouped into three parts: part 1 presents the educational development tradition which has focused on development of staff as teachers; part 2 considers development of staff in…

  3. Directions in Staff Development

    ERIC Educational Resources Information Center

    Brew, Angela, Ed.

    This collection of readings is intended to provide a source book on best practices in staff development in higher education within a British context. The 13 papers are grouped into three parts: part 1 presents the educational development tradition which has focused on development of staff as teachers; part 2 considers development of staff in…

  4. Rare cancer trial design: lessons from FDA approvals.

    PubMed

    Gaddipati, Himabindu; Liu, Ke; Pariser, Anne; Pazdur, Richard

    2012-10-01

    A systematic analysis of clinical trials supporting rare cancer drug approvals may identify concepts and terms that can inform the effective design of prospective clinical trials for rare cancers. In this article, using annual incidence ≤6 of 100,000 individuals to define "rare cancer," we identified clinical trials for rare cancers, supporting U.S. Food and Drug Administration (FDA) drug approvals for rare cancer indications between December 1987 and May 2011. We characterized each selected trial for study design, sample size, primary efficacy endpoints, and statistical comparisons. We also profiled trials with regard to type of submission, review designation, and approval type. Our results indicated that, of 99 trials that supported the approvals of 45 drugs for 68 rare cancer indications, one third of these trials were randomized; 69% of approvals relied on objective response rate as the primary efficacy endpoint; and 63% were based on a single trial. Drugs granted accelerated approval appeared more likely to be associated with postmarketing safety findings, relative to drugs approved under the regular approval. Data collected across clinical trials were robust: Use of different lower incidence rates in analyzing these trials did not have effects on trial characteristics. The absolute number of drug approvals for rare cancer indications increased markedly over time. We concluded that one third of clinical trials supporting drug approvals for rare cancer indications were randomized, affirming the feasibility and value of randomized trial design to evaluate drugs for rare cancers. Postmarketing safety data may relate to trial design and approval type. An operational definition of "rare cancer" can be useful for the analysis of trial data and for the path toward harmonizing the terminology in the area of clinical research on rare cancers.

  5. The FDA alert on suicidality and antiepileptic drugs: Fire or false alarm?

    PubMed

    Hesdorffer, Dale C; Kanner, Andres M

    2009-05-01

    In January 2008, the U.S. Food and Drug Administration (FDA) issued an alert about an increased risk for suicidality in 199 clinical trials of 11 antiepileptic drugs (AEDs) for three different indications, including epilepsy. An advisory panel voted against a black-box warning on AED labels, and the FDA has accepted this recommendation. We discuss three potential problems with the alert. First, adverse event data were used rather than systematically collected data. Second, the 11 drugs grouped together as a single class of AEDs have different mechanisms of action and very different relative risks, many of which were not statistically significant and some of which were smaller than one. These facts suggest that they should not be grouped as a class. Third, the risk of adverse effects from uncontrolled seizures almost certainly outweighs the small risk of suicidality. We place our comments in the context of a review of the literature on suicidality and depression in epilepsy and the sparse literature on AEDs and suicidality. We recommend that all patients with epilepsy be routinely evaluated for depression, anxiety, and suicidality, and that future clinical trials include validated instruments to systematically assess these conditions to determine whether the possible signal observed by the FDA is real.

  6. The FDA's Experience with Emerging Genomics Technologies-Past, Present, and Future.

    PubMed

    Xu, Joshua; Thakkar, Shraddha; Gong, Binsheng; Tong, Weida

    2016-07-01

    The rapid advancement of emerging genomics technologies and their application for assessing safety and efficacy of FDA-regulated products require a high standard of reliability and robustness supporting regulatory decision-making in the FDA. To facilitate the regulatory application, the FDA implemented a novel data submission program, Voluntary Genomics Data Submission (VGDS), and also to engage the stakeholders. As part of the endeavor, for the past 10 years, the FDA has led an international consortium of regulatory agencies, academia, pharmaceutical companies, and genomics platform providers, which was named MicroArray Quality Control Consortium (MAQC), to address issues such as reproducibility, precision, specificity/sensitivity, and data interpretation. Three projects have been completed so far assessing these genomics technologies: gene expression microarrays, whole genome genotyping arrays, and whole transcriptome sequencing (i.e., RNA-seq). The resultant studies provide the basic parameters for fit-for-purpose application of these new data streams in regulatory environments, and the solutions have been made available to the public through peer-reviewed publications. The latest MAQC project is also called the SEquencing Quality Control (SEQC) project focused on next-generation sequencing. Using reference samples with built-in controls, SEQC studies have demonstrated that relative gene expression can be measured accurately and reliably across laboratories and RNA-seq platforms. Besides prediction performance comparable to microarrays in clinical settings and safety assessments, RNA-seq is shown to have better sensitivity for low expression and reveal novel transcriptomic features. Future effort of MAQC will be focused on quality control of whole genome sequencing and targeted sequencing.

  7. The FDA and designing clinical trials for chronic cutaneous ulcers.

    PubMed

    Maderal, Andrea D; Vivas, Alejandra C; Eaglstein, William H; Kirsner, Robert S

    2012-12-01

    Treatment of chronic wounds can present a challenge, with many patients remaining refractory to available advanced therapies. As such, there is a strong need for the development of new products. Unfortunately, despite this demand, few new wound-related drugs have been approved over the past decade. This is in part due to unsuccessful clinical trials and subsequent lack of Food and Drug Administration (FDA) approval. In this article, we discuss the FDA approval process, how it relates to chronic wound trials, common issues that arise, and how best to manage them. Additionally, problems encountered specific to diabetic foot ulcers (DFU) and venous leg ulcers (VLU) are addressed. Careful construction of a clinical trial is necessary in order to achieve the best possible efficacy outcomes and thereby, gain FDA approval. How to design an optimal trial is outlined.

  8. Aligning institutional priorities: engaging house staff in a quality improvement and safety initiative to fulfill Clinical Learning Environment Review objectives and electronic medical record Meaningful Use requirements.

    PubMed

    Flanagan, Meghan R; Foster, Carolyn C; Schleyer, Anneliese; Peterson, Gene N; Mandell, Samuel P; Rudd, Kristina E; Joyner, Byron D; Payne, Thomas H

    2016-02-01

    House staff quality improvement projects are often not aligned with training institution priorities. House staff are the primary users of inpatient problem lists in academic medical centers, and list maintenance has significant patient safety and financial implications. Improvement of the problem list is an important objective for hospitals with electronic health records under the Meaningful Use program. House staff surveys were used to create an electronic problem list manager (PLM) tool enabling efficient problem list updating. Number of new problems added and house staff perceptions of the problem list were compared before and after PLM intervention. The PLM was used by 654 house staff after release. Surveys demonstrated increased problem list updating (P = .002; response rate 47%). Mean new problems added per day increased from 64 pre-PLM to 125 post-PLM (P < .001). This innovative project serves as a model for successful engagement of house staff in institutional quality and safety initiatives with tangible institutional benefits. Copyright © 2016 Elsevier Inc. All rights reserved.

  9. Characteristics of FDA drug recalls: A 30-month analysis.

    PubMed

    Hall, Kelsey; Stewart, Tyler; Chang, Jongwha; Freeman, Maisha Kelly

    2016-02-15

    The characteristics of drug recalls issued over 30 months by the Food and Drug Administration (FDA) were analyzed. All FDA-issued recalls for drugs (prescription and nonprescription, including dietary supplements) and biological products issued from June 20, 2012, to December 31, 2014, were included in this retrospective analysis. Data for all drug recalls were downloaded and sorted by the inclusion criteria from weekly FDA enforcement reports. The following data were analyzed: product type, recall firm, type of recall firm (compounding or noncompounding), country, voluntary or involuntary recall, method of communication of recall, recall number, FDA recall classification (class I, II, or III), product availability (prescription or nonprescription), reason for recall, recall initiation date, and recall report date. A total of 21,120 products were recalled during the 30-month study period. Of these, 3,045 drug products (14.4%) met the inclusion criteria and were analyzed. A total of 348 total manufacturers were associated with recalled drug products. The 5 firms most frequently involved in recalls accounted for 299, 273, 212, 118, and 112 recalls. The most common reasons for recalls were contamination, mislabeling, adverse reaction, defective product, and incorrect potency. There was a significant association between FDA recall classification and the following outcomes: reasons for recall, product availability, type of recall firm, and form of communication. An investigation of FDA drug recalls revealed that the five most common recall reasons were contamination, mislabeling, adverse reaction, defective product, and incorrect potency. Compounding firms were associated more frequently with contamination than were noncompounding firms. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

  10. Public comments on the proposed 10 CFR Part 51 rule for renewal of nuclear power plant operating licenses and supporting documents: Review of concerns and NRC staff response. Volume 1

    SciTech Connect

    1996-05-01

    This report documents the Nuclear Regulatory Commission (NRC) staff review of public comments provided in response to the NRC`s proposed amendments to 10 Code of Federal Regulations (CFR) Part 51, which establish new requirements for the environmental review of applications for the renewal of operating licenses of nuclear power plants. The public comments include those submitted in writing, as well as those provided at public meetings that were held with other Federal agencies, State agencies, nuclear industry representatives, public interest groups, and the general public. This report also contains the NRC staff response to the various concerns raised, and highlights the changes made to the final rule and the supporting documents in response to these concerns.

  11. Bayesian statistics in medical devices: innovation sparked by the FDA.

    PubMed

    Campbell, Gregory

    2011-09-01

    Bayesian statistical methodology has been used for more than 10 years in medical device premarket submissions to the U.S. Food and Drug Administration (FDA). A complete list of the publicly available information associated with these FDA applications is presented. In addition to the increasing number of Bayesian methodological papers in the statistical journals, a number of successful Bayesian clinical trials in the biomedical journals have been recently reported. Some challenges that require more methodological development are discussed. The promise of using Bayesian methods for incorporation of prior information as well as for conducting adaptive trials is great.

  12. Research priorities and infrastructure needs of the Family Smoking Prevention and Tobacco Control Act: science to inform FDA policy.

    PubMed

    Leischow, Scott J; Zeller, Mitch; Backinger, Cathy L

    2012-01-01

    A new law in the United States gives the Food and Drug Administration (FDA) wide latitude to regulate tobacco products for the first time. Given the need for science to serve as a foundation for FDA actions, it is critical that a scientific review of the literature relevant to the proposed legislation be undertaken by experts in the field of nicotine and tobacco research in order to develop research priorities. This paper describes an initiative that was implemented to identify research opportunities under "The Family Smoking Prevention and Tobacco Control Act" and summarizes the conclusions and future directions derived from that initiative. Multiple research and surveillance needs were identified, such as characterization of biomarkers and increased analysis of risk perception. It was also recognized that science will play a critical role in policy determinations such as what constitutes "substantial equivalence" and that there will be considerable infrastructure needs (e.g., laboratories for product testing). Science must drive FDA's decision making regarding tobacco regulation. This article provides a summary of research opportunities identified through literature reviews related to various provisions of the new law. However, the science required by the law requires a transdisciplinary approach because of its complexity, so one of the challenges facing the FDA will be to connect the silos of research in recognition that the "system" of tobacco regulation is greater than the sum of its parts.

  13. 76 FR 789 - Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-06

    ...; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products; Availability AGENCY... announcing the availability of a guidance for industry and FDA staff entitled ``Section 905(j) Reports... products before they may be marketed; alternatively, manufacturers may submit a 905(j) report intended...

  14. 76 FR 41803 - Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-15

    ... Differentiation of Influenza Viruses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Differentiation of Influenza Viruses.'' FDA is issuing this guidance to inform industry and Agency staff of its... diagnostic devices intended for the detection or detection and differentiation of influenza viruses. DATES...

  15. 75 FR 47603 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA...

  16. 76 FR 570 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-05

    ... Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of... Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi.'' FDA is... detection of antibodies to Borrelia burgdorferi. These devices are used to aid in the diagnosis of Lyme...

  17. 75 FR 3238 - Draft Guidance for Industry and Food and Drug Administration Staff; Heart Valves...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-20

    ... Staff; Heart Valves -- Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications... Administration (FDA) is announcing the availability of the draft guidance document entitled ``Heart Valves... for heart valves. This draft guidance document is not final, nor is it in effect at this time. DATES...

  18. 76 FR 36133 - Draft Guidances for Industry and Food and Drug Administration Staff: Classification of Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-21

    ... if: ``through either chemical reaction or intermolecular forces or both, the product mediates a... Issues; and Interpretation of the Term ``Chemical Action'' in the Definition of Device Under Section 201...'' and ``Draft Guidance for Industry and FDA Staff: Interpretation of the Term 'Chemical Action' in the...

  19. Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014

    PubMed Central

    Hatswell, Anthony J; Baio, Gianluca; Berlin, Jesse A; Irs, Alar; Freemantle, Nick

    2016-01-01

    Introduction The efficacy of pharmaceuticals is most often demonstrated by randomised controlled trials (RCTs); however, in some cases, regulatory applications lack RCT evidence. Objective To investigate the number and type of these approvals over the past 15 years by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Methods Drug approval data were downloaded from the EMA website and the ‘Drugs@FDA’ database for all decisions on pharmaceuticals published from 1 January 1999 to 8 May 2014. The details of eligible applications were extracted, including the therapeutic area, type of approval and review period. Results Over the period of the study, 76 unique indications were granted without RCT results (44 by the EMA and 60 by the FDA), demonstrating that a substantial number of treatments reach the market without undergoing an RCT. The majority was for haematological malignancies (34), with the next most common areas being oncology (15) and metabolic conditions (15). Of the applications made to both agencies with a comparable data package, the FDA granted more approvals (43/44 vs 35/44) and took less time to review products (8.7 vs 15.5 months). Products reached the market first in the USA in 30 of 34 cases (mean 13.1 months) due to companies making FDA submission before EMA submissions and faster FDA review time. Discussion Despite the frequency with which approvals are granted without RCT results, there is no systematic monitoring of such treatments to confirm their effectiveness or consistency regarding when this form of evidence is appropriate. We recommend a more open debate on the role of marketing authorisations granted without RCT results, and the development of guidelines on what constitutes an acceptable data package for regulators. PMID:27363818

  20. FDA requirements for nonclinical testing of contraceptive steroids.

    PubMed

    Jordan, A

    1992-12-01

    Written guidelines for the preclinical testing of contraceptive steroids have not been revised since 1968 despite the fact that many important changes have been implemented by the FDA's Division of Metabolism and Endocrine Drug Products. This paper describes the new preclinical testing requirements and the rationale for their implementation.

  1. 36 CFR 13.980 - Other FDA closures and restrictions.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 36 Parks, Forests, and Public Property 1 2013-07-01 2013-07-01 false Other FDA closures and restrictions. 13.980 Section 13.980 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK SYSTEM UNITS IN ALASKA Special Regulations-Denali National Park...

  2. Diabetes Drug Gets FDA Warning Due to Amputation Risk

    MedlinePlus

    ... html Diabetes Drug Gets FDA Warning Due to Amputation Risk Canagliflozin tied to a doubling of amputations of legs, feet, agency says To use the ... to increase the risk of leg and foot amputations, the U.S. Food and Drug Administration says. The ...

  3. 17 CFR 38.155 - Compliance staff and resources.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 17 Commodity and Securities Exchanges 1 2013-04-01 2013-04-01 false Compliance staff and resources... DESIGNATED CONTRACT MARKETS Compliance With Rules § 38.155 Compliance staff and resources. (a) Sufficient... resources and staff to ensure that it can conduct effective audit trail reviews, trade practice...

  4. 17 CFR 38.155 - Compliance staff and resources.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 17 Commodity and Securities Exchanges 1 2014-04-01 2014-04-01 false Compliance staff and resources... DESIGNATED CONTRACT MARKETS Compliance With Rules § 38.155 Compliance staff and resources. (a) Sufficient... resources and staff to ensure that it can conduct effective audit trail reviews, trade practice...

  5. Demographics of clinical trials participants in pivotal clinical trials for new molecular entity drugs and biologics approved by FDA From 2010 to 2012.

    PubMed

    Eshera, Noha; Itana, Hawi; Zhang, Lei; Soon, Greg; Fadiran, Emmanuel O

    2015-01-01

    To fully assess the safety and efficacy of therapeutics before approval, the US Food and Drug Administration (FDA) has encouraged adequate representation and assessment of demographic subgroups in clinical trials through guidance documents and regulations. This study aimed to survey the demographics of participants in pivotal clinical trials, as well as the presence of analyses by sex on efficacy and safety for FDA-approved new drug applications (NDAs) and biologics license applications (BLAs) from 2010 to 2012. Medical and statistical reviews for new molecular entity drugs and biological products approved during this period were obtained from Drugs@FDA. All pivotal clinical trials referenced in the FDA reviews were evaluated for the participation of different demographic subgroups (such as sex, race/ethnicity, and age). Pivotal trials were defined as those phase 2 and/or phase 3 trials described in the labeling or the FDA medical reviews in support of the drug/biological approval. Eighty-three new molecular entities (66 NDAs and 17 BLAs) were approved by the FDA from 2010 to 2012. Overall, women constituted 45% of trial participants for NDAs and 65% for BLAs. Sex analysis related to safety and efficacy was reported in 92% of the surveyed FDA medical and statistical reviews. Most NDAs and BLAs (82%) had a study population that was representative of the sex distribution for the intended patient population; however, most study participants were whites (77%), and minority racial/ethnic groups had lower participation rates in the study population than would be representative of the US racial group populations.

  6. A Review of Research on Direct-Care Staff Data Collection Regarding the Severity and Function of Challenging Behavior in Individuals with Intellectual and Developmental Disabilities

    ERIC Educational Resources Information Center

    Madsen, Emily K.; Peck, Janelle A.; Valdovinos, Maria G.

    2016-01-01

    In working with individuals with intellectual and developmental disabilities (IDDs), it is direct care staff who are often required to collect data on individuals' behavior which is used as the basis for implementation of empirically based approaches for intervention and treatment. Due to limited resources, indirect and descriptive measures of…

  7. A Review of Research on Direct-Care Staff Data Collection Regarding the Severity and Function of Challenging Behavior in Individuals with Intellectual and Developmental Disabilities

    ERIC Educational Resources Information Center

    Madsen, Emily K.; Peck, Janelle A.; Valdovinos, Maria G.

    2016-01-01

    In working with individuals with intellectual and developmental disabilities (IDDs), it is direct care staff who are often required to collect data on individuals' behavior which is used as the basis for implementation of empirically based approaches for intervention and treatment. Due to limited resources, indirect and descriptive measures of…

  8. The FDA, contraceptive marketing approval and products liability litigation: Depo-Provera and the risk of osteoporosis.

    PubMed

    Green, William

    2013-01-01

    The FDA approved Depo-Provera, an injectable contraceptive, in 1992 on the condition that its manufacturer conduct a post-approval study on the risk ofosteoporosis. Then in 2004, the agency revised the drug's labeling to include a boxed (i.e. Black Box) Warning on the risk ofosteoporosis. This article will analyze the FDA's Depo-Provera approval and label revision process: the agency's acceptance of Upjohn's New Drug Application, its Fertility and Maternal Health Advisory Committee's review of the human clinical studies and approval recommendation, its marketing approval of Depo-Provera, and its 2004 drug labeling revision. Then the article will analyze the post-2004 products liability litigation by women who claimed to have been injured by their use of the drug. None of the cases have survived the manufacturer's summary judgment motions, because the women have been unable to establish by expert and physician evidence that the FDA-approved labeling was inadequate to inform their physicians of the risk of osteoporosis, that the inadequate warnings caused their osteoporosis or osteopenia, and that these are compensable injuries. As a result, the manufacturer has been able to use the FDA labeling, state products liability law, and the learned intermediary doctrine to avoid liability. The conclusion will consider the lessons of these products liability cases for other women who have received Depo-Provera and suffered bone mineral density loss.

  9. Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012.

    PubMed

    Sacks, Leonard V; Shamsuddin, Hala H; Yasinskaya, Yuliya I; Bouri, Khaled; Lanthier, Michael L; Sherman, Rachel E

    Some new drug applications fail because of inadequate drug performance and others are not approved because the information submitted to the US Food and Drug Administration (FDA) is unsatisfactory to make that determination. Resubmission of failed applications is costly, delaying marketing approval and the availability of new drugs to patients. To identify the reasons that FDA marketing approval for new drugs was delayed or denied. A retrospective review of FDA documents and extraction of data were performed. We examined all drug applications first submitted to the FDA between 2000 and 2012 for new molecular entities (NMEs), which are active ingredients never before marketed in the United States in any form. Using FDA correspondence and reviews, we investigated the reasons NMEs failed to obtain FDA approval. Reasons for delayed FDA approval or nonapproval of NME applications. Of the 302 identified NME applications, 151 (50%) were approved when first submitted and 222 (73.5%) were ultimately approved. Seventy-one applications required 1 or more resubmissions before approval, with a median delay to approval of 435 days following the first unsuccessful submission. Of the unsuccessful first-time applications, 24 (15.9%) included uncertainties related to dose selection, 20 (13.2%) choice of study end points that failed to adequately reflect a clinically meaningful effect, 20 (13.2%) inconsistent results when different end points were tested, 17 (11.3%) inconsistent results when different trials or study sites were compared, and 20 (13.2%) poor efficacy when compared with the standard of care. The frequency of safety deficiencies was similar among never-approved drugs compared with those with delayed approval (43 of 80 never approved [53.8%] vs 37 of 71 eventually approved [52.1%]; difference, 1.7% [95% CI, -14.86% to 18.05%]; P = .87). However, efficacy deficiencies were significantly more frequent among the never-approved drugs than among those with delayed approvals

  10. Revisiting financial conflicts of interest in FDA advisory committees.

    PubMed

    Pham-Kanter, Genevieve

    2014-09-01

    The Food and Drug Administration (FDA) Safety and Innovation Act has recently relaxed conflict-of-interest rules for FDA advisory committee members, but concerns remain about the influence of members' financial relationships on the FDA's drug approval process. Using a large newly available data set, this study carefully examined the relationship between the financial interests of FDA Center for Drug Evaluation and Research (CDER) advisory committee members and whether members voted in a way favorable to these interests. The study used a data set of voting behavior and reported financial interests of 1,379 FDA advisory committee members who voted in CDER committee meetings that were convened during the 15-year period of 1997-2011. Data on 1,168 questions and 15,739 question-votes from 379 meetings were used in the analyses. Multivariable logit models were used to estimate the relationship between committee members' financial interests and their voting behavior. Individuals with financial interests solely in the sponsoring firm were more likely to vote in favor of the sponsor than members with no financial ties (OR = 1.49, p = 0.03). Members with interests in both the sponsoring firm and its competitors were no more likely to vote in favor of the sponsor than those with no financial ties to any potentially affected firm (OR = 1.16, p = 0.48). Members who served on advisory boards solely for the sponsor were significantly more likely to vote in favor of the sponsor (OR = 4.97, p = 0.005). There appears to be a pro-sponsor voting bias among advisory committee members who have exclusive financial relationships with the sponsoring firm but not among members who have nonexclusive financial relationships (ie, those with ties to both the sponsor and its competitors). These findings point to important heterogeneities in financial ties and suggest that policymakers will need to be nuanced in their management of financial relationships of FDA advisory committee members.

  11. Revisiting Financial Conflicts of Interest in FDA Advisory Committees

    PubMed Central

    Pham-Kanter, Genevieve

    2014-01-01

    Context The Food and Drug Administration (FDA) Safety and Innovation Act has recently relaxed conflict-of-interest rules for FDA advisory committee members, but concerns remain about the influence of members’ financial relationships on the FDA's drug approval process. Using a large newly available data set, this study carefully examined the relationship between the financial interests of FDA Center for Drug Evaluation and Research (CDER) advisory committee members and whether members voted in a way favorable to these interests. Methods The study used a data set of voting behavior and reported financial interests of 1,379 FDA advisory committee members who voted in CDER committee meetings that were convened during the 15-year period of 1997–2011. Data on 1,168 questions and 15,739 question-votes from 379 meetings were used in the analyses. Multivariable logit models were used to estimate the relationship between committee members’ financial interests and their voting behavior. Findings Individuals with financial interests solely in the sponsoring firm were more likely to vote in favor of the sponsor than members with no financial ties (OR = 1.49, p = 0.03). Members with interests in both the sponsoring firm and its competitors were no more likely to vote in favor of the sponsor than those with no financial ties to any potentially affected firm (OR = 1.16, p = 0.48). Members who served on advisory boards solely for the sponsor were significantly more likely to vote in favor of the sponsor (OR = 4.97, p = 0.005). Conclusions There appears to be a pro-sponsor voting bias among advisory committee members who have exclusive financial relationships with the sponsoring firm but not among members who have nonexclusive financial relationships (ie, those with ties to both the sponsor and its competitors). These findings point to important heterogeneities in financial ties and suggest that policymakers will need to be nuanced in their management of financial

  12. Internationalize Your Camp Staff.

    ERIC Educational Resources Information Center

    Grier, Linda J.

    1986-01-01

    Provides a rationale for using international applicants for American summer camp positions and summarizes the services of organizations that screen, interview, and orient qualified applicants. Discusses contributions that international staff can make to a camp program with a global perspective and points out staff orientation and other practical…

  13. Why Do Staff Return?

    ERIC Educational Resources Information Center

    Magnuson, Connie

    1992-01-01

    Surveyed 211 returning staff from 25 camps and interviewed 19 returning staff to study factors that influence a counselor's decision to return to camp. Examined the following dimensions of motivation and hygiene factors: (1) stimulation or inspiration; (2) personal; (3) job-related experience; (4) living conditions and camp life; (5) camp…

  14. Battle Command Staff Training

    DTIC Science & Technology

    1992-12-01

    collective performance. There are a variety of ideas that need attention, ranging Lvm how * staffs should operate vertically , how to measure staff...4-12 Preparation for Vertical BCST .........................................lC S...1.1-1 Appendix 1.2- Vertical BCST-Fire Support ........................................ 1.2-1 Appendix 1.3- Conceptual Innovations in Battle

  15. Listening to Staff, 2002.

    ERIC Educational Resources Information Center

    Owen, Jane; Davies, Peter

    A 2002 staff satisfaction survey was administered to 100 sixth form colleges, general further education colleges, and beacon and specialist colleges in England. A questionnaire containing 38 positive statements concerning 6 broad areas one's own role; the staff of the college; style of senior management; communication; customers, including…

  16. Developing Staff Morale.

    ERIC Educational Resources Information Center

    Wentworth, Marylyn

    1990-01-01

    Low staff morale results from professional lives that have little meaning; from frustration and the inability to change what is happening; and from muddled goals and demands exceeding scarce resources. Schools with high staff morale have very distinctive features, including a sense of community. Factors determining high morale are: (1) input into…

  17. Export of pharmaceuticals and medical devices under the federal Food, Drug & Cosmetic Act: FDA's striking change in interpretation post-Shelhigh.

    PubMed

    Basile, Edward M; Tolomeo, Deborah; Gluck, Elizabeth

    2009-01-01

    With no communication to industry except court filings in United States v. Undetermined Quantities of Boxes of Articles of Device (Shelhigh) and a draft guidance document, the Food and Drug Administration (FDA) has articulated new policies regarding export of pharmaceutical products and medical devices. FDA's departure from its historic interpretation of the export provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) significantly limits the ability of manufacturers to export misbranded drugs and medical devices that FDA deems "adulterated," contrary to the plain language and legislative intent of the FDCA. To further exacerbate the issue, FDA has begun to implement these policies without the notice-and-comment rulemaking required by the Administrative Procedures Act (APA), but rather through an enforcement proceeding brought in the United States District Court for the District of New Jersey. In a letter opinion, the District Court prevented the export of Current Good Manufacturing Practices (CGMP) --adulterated medical devices that complied with FDCA Section 801(e)(1), at least as historically interpreted by FDA. The purpose of this article is to review the history of FDA's export policies for pharmaceuticals and medical devices, particularly those aspects of the export policies that are affected by FDA's recent change in position. Three changes in FDA's interpretation of the export provisions of the FDCA will be addressed: 1) unapproved devices that a manufacturer reasonably believes are eligible for Section 510(k) clearance may no longer be exported under Section 801(e) and now must be exported under Section 802, in substantial compliance with Current CGMP; 2) adulterated devices and misbranded drugs can only be exported if the foreign purchaser's specifications cause the product to be adulterated; and 3) an article may not be exported if a like article has ever been sold or offered for sale in domestic commerce. FDA's new interpretations of FDCA

  18. Timelines of translational science: From technology initiation to FDA approval.

    PubMed

    McNamee, Laura M; Walsh, Michael Jay; Ledley, Fred D

    2017-01-01

    While timelines for clinical development have been extensively studied, there is little data on the broader path from initiation of research on novel drug targets, to approval of drugs based on this research. We examined timelines of translational science for 138 drugs and biologicals approved by the FDA from 2010-2014 using an analytical model of technology maturation. Research on targets for 102 products exhibited a characteristic (S-curve) maturation pattern with exponential growth between statistically defined technology initiation and established points. The median initiation was 1974, with a median of 25 years to the established point, 28 years to first clinical trials, and 36 years to FDA approval. No products were approved before the established point, and development timelines were significantly longer when the clinical trials began before this point (11.5 vs 8.5 years, p<0.0005). Technological maturation represents the longest stage of translation, and significantly impacts the efficiency of drug development.

  19. The FDA pesticides program: goals and new approaches.

    PubMed

    Lombardo, P

    1989-01-01

    The U.S. Food and Drug Administration (FDA) has carried out a large-scale monitoring program for pesticide residues in foods since the 1960s. The program has evolved continuously as evidenced by a number of recently incorporated modifications and initiatives. Included are greater emphasis on imports; increased and more specific targeting of pesticide/commodity combinations by geographic area or country; development of individual district sampling plans for domestic and imported foods; expanded use of single residue methods; linkage of information on foreign pesticide usage with food import volumes; development of an analytical methods research plan; and increased cooperative sampling and data exchange with the states. Initiatives to acquire and utilize private sector and other monitoring data are being explored, and aggressive steps are being taken to inform the public of FDA monitoring results in a timely and understandable manner.

  20. The first FDA marketing authorizations of next-generation sequencing technology and tests: challenges, solutions and impact for future assays.

    PubMed

    Bijwaard, Karen; Dickey, Jennifer S; Kelm, Kellie; Težak, Živana

    2015-01-01

    The rapid emergence and clinical translation of novel high-throughput sequencing technologies created a need to clarify the regulatory pathway for the evaluation and authorization of these unique technologies. Recently, the US FDA authorized for marketing four next generation sequencing (NGS)-based diagnostic devices which consisted of two heritable disease-specific assays, library preparation reagents and a NGS platform that are intended for human germline targeted sequencing from whole blood. These first authorizations can serve as a case study in how different types of NGS-based technology are reviewed by the FDA. In this manuscript we describe challenges associated with the evaluation of these novel technologies and provide an overview of what was reviewed. Besides making validated NGS-based devices available for in vitro diagnostic use, these first authorizations create a regulatory path for similar future instruments and assays.

  1. 21 CFR 1.279 - When must prior notice be submitted to FDA?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... submitted via Automated Broker Interface/Automated Commercial System (ABI/ACS), you may not submit prior... submitted via the FDA Prior Notice System Interface (FDA PNSI), you may not submit prior notice more than...

  2. 21 CFR 1.279 - When must prior notice be submitted to FDA?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... submitted via Automated Broker Interface/Automated Commercial System (ABI/ACS), you may not submit prior... submitted via the FDA Prior Notice System Interface (FDA PNSI), you may not submit prior notice more than...

  3. 21 CFR 1.279 - When must prior notice be submitted to FDA?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... submitted via Automated Broker Interface/Automated Commercial System (ABI/ACS), you may not submit prior... submitted via the FDA Prior Notice System Interface (FDA PNSI), you may not submit prior notice more than...

  4. 21 CFR 1.279 - When must prior notice be submitted to FDA?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... submitted via Automated Broker Interface/Automated Commercial System (ABI/ACS), you may not submit prior... submitted via the FDA Prior Notice System Interface (FDA PNSI), you may not submit prior notice more than...

  5. 21 CFR 1.279 - When must prior notice be submitted to FDA?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... submitted via Automated Broker Interface/Automated Commercial System (ABI/ACS), you may not submit prior... submitted via the FDA Prior Notice System Interface (FDA PNSI), you may not submit prior notice more than...

  6. 食品药物管理局( FDA

    Center for Drug Evaluation (CDER)

    ... 士应立即与医疗保健专业人员联络咨询。 接触铅会对中央神经系统、肾、和免疫 系统造成严重的 ... 下载并完成表格,然后经传真至 1-800-FDA-0178 提交。 ...

  7. A review of research on direct-care staff data collection regarding the severity and function of challenging behavior in individuals with intellectual and developmental disabilities.

    PubMed

    Madsen, Emily K; Peck, Janelle A; Valdovinos, Maria G

    2016-09-01

    In working with individuals with intellectual and developmental disabilities (IDDs), it is direct care staff who are often required to collect data on individuals' behavior which is used as the basis for implementation of empirically based approaches for intervention and treatment. Due to limited resources, indirect and descriptive measures of challenging behaviors are employed to analyze the function of individuals' behaviors in place of the preferred method of multimodal assessment, which includes experimental functional analysis. To ensure the most effective services and support to individuals with IDDs, accurate and consistent data collection is critical. In this article, we highlight the importance of accurate data collection practices, conduct a comparison of data collection methods, and discuss limitations .… and barriers for staff. The article concludes with recommendations for best practices and future research.

  8. FDA Benchmark Medical Device Flow Models for CFD Validation.

    PubMed

    Malinauskas, Richard A; Hariharan, Prasanna; Day, Steven W; Herbertson, Luke H; Buesen, Martin; Steinseifer, Ulrich; Aycock, Kenneth I; Good, Bryan C; Deutsch, Steven; Manning, Keefe B; Craven, Brent A

    Computational fluid dynamics (CFD) is increasingly being used to develop blood-contacting medical devices. However, the lack of standardized methods for validating CFD simulations and blood damage predictions limits its use in the safety evaluation of devices. Through a U.S. Food and Drug Administration (FDA) initiative, two benchmark models of typical device flow geometries (nozzle and centrifugal blood pump) were tested in multiple laboratories to provide experimental velocities, pressures, and hemolysis data to support CFD validation. In addition, computational simulations were performed by more than 20 independent groups to assess current CFD techniques. The primary goal of this article is to summarize the FDA initiative and to report recent findings from the benchmark blood pump model study. Discrepancies between CFD predicted velocities and those measured using particle image velocimetry most often occurred in regions of flow separation (e.g., downstream of the nozzle throat, and in the pump exit diffuser). For the six pump test conditions, 57% of the CFD predictions of pressure head were within one standard deviation of the mean measured values. Notably, only 37% of all CFD submissions contained hemolysis predictions. This project aided in the development of an FDA Guidance Document on factors to consider when reporting computational studies in medical device regulatory submissions. There is an accompanying podcast available for this article. Please visit the journal's Web site (www.asaiojournal.com) to listen.

  9. The FDA's sentinel initiative--A comprehensive approach to medical product surveillance.

    PubMed

    Ball, R; Robb, M; Anderson, S A; Dal Pan, G

    2016-03-01

    In May 2008, the Department of Health and Human Services announced the launch of the Sentinel Initiative by the US Food and Drug Administration (FDA) to create the Sentinel System, a national electronic system for medical product safety surveillance. This system complements existing FDA surveillance capabilities that track adverse events reported after the use of FDA regulated products by allowing the FDA to proactively assess the safety of these products.

  10. The hospital board at risk and the need to restructure the relationship with the medical staff: bylaws, peer review and related solutions.

    PubMed

    Marren, John P; Feazell, G Landon; Paddock, Michael W

    2003-01-01

    This article argues that the current structure of the hospital governing board and medical staff relationship does not support and promote quality and patient-centered care. The fundamental flaw in the current structure is the interdependent, yet independent and discordant relationships between hospital governing boards and medical staffs. These relationships are described as cultures and fit into three types of "silos": organizational (the "structural silo"); professional (the "professional silo", including the "culture of blame"); and the fragmented quality information silo (the "informational silo"). While case law, statutory requirements and regulatory expectations clearly state that governing boards are ultimately responsible for quality of patient care, governing boards delegate these functions to medical staff without having sufficient information to measure and monitor quality. As a result, problems manifest because of these failures of oversight and compliance. Dramatic lapses in quality occur due to overuse, underuse, and misuse of healthcare services. Furthermore, the challenges and opportunities from improved quality and patient safety, as a strategic business driver, cannot be seized until the underlying structural flaws are understood and addressed. This article proposes that solutions become apparent when the various health care constituencies are educated about these cultural impacts and when multidisciplinary bodies, with board leadership and direct authority, integrate and consider quality information.

  11. BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements.

    PubMed

    Davit, Barbara M; Kanfer, Isadore; Tsang, Yu Chung; Cardot, Jean-Michel

    2016-05-01

    The Biopharmaceutics Classification System (BCS), based on aqueous solubility and intestinal permeability, has enjoyed wide use since 1995 as a mechanism for waiving in vivo bioavailability and bioequivalence studies. In 2000, the US-FDA was the first regulatory agency to publish guidance for industry describing how to meet criteria for requesting a waiver of in vivo bioavailability and bioequivalence studies for highly soluble, highly permeable (BCS Class I) drugs. Subsequently, the World Health Organization (WHO) and European Medicines Agency (EMA) published guidelines recommending how to obtain BCS biowaivers for BCS Class III drugs (high solubility, low permeability), in addition to Class I drugs. In 2015, the US-FDA became better harmonized with the EMA and WHO following publication of two guidances for industry outlining criteria for obtaining BCS biowaivers for both Class I and Class III drugs. A detailed review and comparison of the BCS Class I and Class III criteria currently recommended by the US-FDA, EMA, and WHO revealed good convergence of the three agencies with respect to BCS biowaiver criteria. The comparison also suggested that, by applying the most conservative of the three jurisdictional approaches, it should be possible for a sponsor to design the same set of BCS biowaiver studies in preparing a submission for worldwide filing to satisfy US, European, and emerging market regulators. It is hoped that the availability of BCS Class I and Class III biowaivers in multiple jurisdictions will encourage more sponsors to request waivers of in vivo bioavailability/bioequivalence testing using the BCS approach.

  12. Staff Acceptance of Tele-ICU Coverage

    PubMed Central

    Chan, Paul S.; Cram, Peter

    2011-01-01

    Background: Remote coverage of ICUs is increasing, but staff acceptance of this new technology is incompletely characterized. We conducted a systematic review to summarize existing research on acceptance of tele-ICU coverage among ICU staff. Methods: We searched for published articles pertaining to critical care telemedicine systems (aka, tele-ICU) between January 1950 and March 2010 using PubMed, Cumulative Index to Nursing and Allied Health Literature, Global Health, Web of Science, and the Cochrane Library and abstracts and presentations delivered at national conferences. Studies were included if they provided original qualitative or quantitative data on staff perceptions of tele-ICU coverage. Studies were imported into content analysis software and coded by tele-ICU configuration, methodology, participants, and findings (eg, positive and negative staff evaluations). Results: Review of 3,086 citations yielded 23 eligible studies. Findings were grouped into four categories of staff evaluation: overall acceptance level of tele-ICU coverage (measured in 70% of studies), impact on patient care (measured in 96%), impact on staff (measured in 100%), and organizational impact (measured in 48%). Overall acceptance was high, despite initial ambivalence. Favorable impact on patient care was perceived by > 82% of participants. Staff impact referenced enhanced collaboration, autonomy, and training, although scrutiny, malfunctions, and contradictory advice were cited as potential barriers. Staff perceived the organizational impact to vary. An important limitation of available studies was a lack of rigorous methodology and validated survey instruments in many studies. Conclusions: Initial reports suggest high levels of staff acceptance of tele-ICU coverage, but more rigorous methodologic study is required. PMID:21051386

  13. 21 CFR 1.405 - When does FDA have to issue a decision on an appeal?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false When does FDA have to issue a decision on an... Consumption What Is the Appeal Process for A Detention Order? § 1.405 When does FDA have to issue a decision... final decision within the 5-calendar day period after the appeal is filed. If FDA either fails...

  14. 76 FR 61709 - Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Form 3728...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-05

    ... Collection; Comment Request; FDA Form 3728, Animal Generic Drug User Fee Act Cover Sheet AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing... Drug User Fee Cover Sheet Form FDA 3728 that further implements certain provisions of the...

  15. 21 CFR 1.406 - How will FDA handle classified information in an informal hearing?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false How will FDA handle classified information in an... Animal Consumption What Is the Appeal Process for A Detention Order? § 1.406 How will FDA handle... disclosure in the interest of national security (“classified information”), FDA will not provide you...

  16. 21 CFR 1.378 - What criteria does FDA use to order a detention?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What criteria does FDA use to order a detention? 1... General Provisions § 1.378 What criteria does FDA use to order a detention? An officer or qualified employee of FDA may order the detention of any article of food that is found during an...

  17. 21 CFR 111.610 - What records must be made available to FDA?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What records must be made available to FDA? 111... records must be made available to FDA? (a) You must have all records required under this part, or copies of such records, readily available during the retention period for inspection and copying by FDA...

  18. 76 FR 1180 - FDA Transparency Initiative: Improving Transparency to Regulated Industry

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ... HUMAN SERVICES Food and Drug Administration FDA Transparency Initiative: Improving Transparency to... comments. SUMMARY: As part of the third phase of the Transparency Initiative, the Food and Drug Administration (FDA) is announcing the availability of a report entitled ``FDA Transparency Initiative: Improving...

  19. No sisyphean task: how the FDA can regulate electronic cigarettes.

    PubMed

    Paradise, Jordan

    2013-01-01

    The adverse effects of smoking have fostered a natural market for smoking cessation and smoking reduction products. Smokers attempting to quit or reduce consumption have tried everything: "low" or "light" cigarettes; nicotine-infused chewing gum, lozenges, and lollipops; dermal patches; and even hypnosis. The latest craze in the quest to find a safer source of nicotine is the electronic cigarette. Electronic cigarettes (e-cigarettes) have swept the market, reaching a rapidly expanding international consumer base. Boasting nicotine delivery and the tactile feel of a traditional cigarette without the dozens of other chemical constituents that contribute to carcinogenicity, e-cigarettes are often portrayed as less risky, as a smoking reduction or even a complete smoking cessation product, and perhaps most troubling for its appeal to youth, as a flavorful, trendy, and convenient accessory. The sensationalism associated with e-cigarettes has spurred outcry from health and medical professional groups, as well as the Food and Drug Administration (FDA), because of the unknown effects on public health. Inhabiting a realm of products deemed "tobacco products" under recent 2009 legislation, e-cigarettes pose new challenges to FDA regulation because of their novel method of nicotine delivery, various mechanical and electrical parts, and nearly nonexistent safety data. Consumer use, marketing and promotional claims, and technological characteristics of e-cigarettes have also raised decades old questions of when the FDA can assert authority over products as drugs or medical devices. Recent case law restricting FDA enforcement efforts against e-cigarettes further confounds the distinction among drugs and medical devices, emerging e-cigarette products, and traditional tobacco products such as cigarettes, cigars, and smokeless tobacco. This Article investigates the e-cigarette phenomenon in the wake of the recently enacted Family Smoking Prevention and Tobacco Control Act of 2009

  20. A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors.

    PubMed

    Shah, Rashmi R; Roberts, Samantha A; Shah, Devron R

    2013-09-01

    We compared and determined the reasons for any differences in the review and approval times of tyrosine kinase inhibitors (TKIs) by the US Food and Drug Administration (FDA) and the European EMA/CHMP. Applications for these novel cancer drugs were submitted to them within a mean of 31.2 days of each other, providing a fair basis for comparison. The FDA had granted priority review to 12 TKIs but the EMA/CHMP did not grant the equivalent accelerated assessment to any. The FDA granted accelerated approvals to six (38%) and CHMP granted (the equivalent) conditional approvals to four (29%) of these agents. On average, the review and approval times were 205.3 days in the US compared with 409.6 days in the European Union (EU). The active review times, however, were comparable (225.4 days in the EU and 205.3 days in the US). Since oncology drug development lasts about 7 years, the 20 days difference in review times between the two agencies is inconsequential. Clock stops during review and the time required to issue an approval had added the extra 184.2 days to review time in the EU. We suggest possible solutions to expedite the EU review and approval processes. However, post-marketing emergence of adverse efficacy and safety data on gefitinib and lapatinib, respectively, indicate potential risks of expedited approvals. We challenge the widely prevalent myth that early approval translates into early access or beneficial impact on public health. Both the agencies collaborate closely but conduct independent assessments and make decisions based on distinct legislation, procedures, precedents and societal expectations.

  1. The FDA Perspective on Pre-Clinical Testing for High Intensity Focused Ultrasound Devices

    NASA Astrophysics Data System (ADS)

    Harris, Gerald R.

    2006-05-01

    In the U. S., the pre-market review of high intensity focused ultrasound (HIFU) devices is carried out under the authority of the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act. Different regulatory mechanisms may apply depending on the complexity of the HIFU device and the indications for use, but in all cases pre-clinical testing is required. This testing typically includes ultrasound field characterization, thermal modeling and measurement, and may include demonstrating the accuracy of targeting and monitoring, if applicable. Because there are no guidance documents or standards for these tests at present, the U.S. Food and Drug Administration (FDA) welcomes working with interested parties to develop acceptable procedures that can be incorporated into the regulatory review process.

  2. Library staff development course.

    PubMed Central

    Eaton, E K

    1981-01-01

    The Moody Medical Library at the University of Texas Medical Branch plans, presents, and evaluates regularly a staff development program for its employees, including librarians and clerical and technical staff. The program's purpose is to provide continuing education for the library staff while concurrently: (1) providing information concerning specific library services and programs; (2) illustrating the interrelationship of the departments and divisions within the library; (3) developing a sense of teamwork and loyalty; and (4) developing job pride. Staff member volunteers teach the various courses. An integral part of the program is an evaluation of the efficacy of its various components using a form developed specifically for this purpose. Participants give the majority of courses an effectiveness rating of 90% or above. PMID:7248595

  3. Online Staff Development.

    ERIC Educational Resources Information Center

    Pease, Pamela S.; Magnuson, Peter

    2003-01-01

    Describes the benefits for principals of online staff development for teachers. Sources of online courses and training include local and state departments of education, professional associations, colleges and universities, online universities, and commercial suppliers. (PKP)

  4. Motivating Your Development Staff.

    ERIC Educational Resources Information Center

    Henderson, Nancy

    1996-01-01

    Suggestions for motivating institutional advancement staff at colleges and universities include nonfinancial motivators (such as appreciation, team building, empowerment, professional development opportunities, flexibility, and formal recognition) and financial rewards (such as bonuses and merit pay). (DB)

  5. Dose Uniformity of Scored and Unscored Tablets: Application of the FDA Tablet Scoring Guidance for Industry.

    PubMed

    Ciavarella, Anthony B; Khan, Mansoor A; Gupta, Abhay; Faustino, Patrick J

    the world. Tablets are often split to modify dose strength, make swallowing easier, and reduce cost to the consumer. To better address product quality for this widely used practice, the U.S. Food and Drug Administration (FDA) published a Guidance for Industry that addresses tablet splitting. The guidance provides testing criteria for scored tablets, which is a part of the FDA review process for drugs. The model drugs selected for this study were amlodipine and gabapentin, which have different sizes, shapes, and tablet scores. Whole and split amlodipine tablets were tested for drug content because of a concern that the low-dose strength may cause greater variability. Whole and split gabapentin tablets were tested for weight variation because of their higher dosage strength of 600 mg. All whole tablets met the acceptance criteria for the Uniformity of Dosage Units based on the guidance recommendations. When unscored amlodipine tablets were split by a splitter, all formulations did not meet the acceptance criteria. When fully scored gabapentin tablets were split by hand and by splitter, they met the acceptance criteria. The findings of this FDA study indicated physical characteristics such as size, shape, and tablet score can affect the uniformity of split tablets. © PDA, Inc. 2016.

  6. Drug interaction databases in medical literature: transparency of ownership, funding, classification algorithms, level of documentation, and staff qualifications. A systematic review.

    PubMed

    Kongsholm, Gertrud Gansmo; Nielsen, Anna Katrine Toft; Damkier, Per

    2015-11-01

    It is well documented that drug-drug interaction databases (DIDs) differ substantially with respect to classification of drug-drug interactions (DDIs). The aim of this study was to study online available transparency of ownership, funding, information, classifications, staff training, and underlying documentation of the five most commonly used open access English language-based online DIDs and the three most commonly used subscription English language-based online DIDs in the literature. We conducted a systematic literature search to identify the five most commonly used open access and the three most commonly used subscription DIDs in the medical literature. The following parameters were assessed for each of the databases: Ownership, classification of interactions, primary information sources, and staff qualification. We compared the overall proportion of yes/no answers from open access databases and subscription databases by Fisher's exact test-both prior to and after requesting missing information. Among open access DIDs, 20/60 items could be verified from the webpage directly compared to 24/36 for the subscription DIDs (p = 0.0028). Following personal request, these numbers rose to 22/60 and 30/36, respectively (p < 0.0001). For items within the "classification of interaction" domain, proportions were 3/25 versus 11/15 available from the webpage (P = 0.0001) and 3/25 versus 15/15 (p < 0.0001) available upon personal request. Available information on online available transparency of ownership, funding, information, classifications, staff training, and underlying documentation varies substantially among various DIDs. Open access DIDs had a statistically lower score on parameters assessed.

  7. Staffing in postnatal units: is it adequate for the provision of quality care? Staff perspectives from a state-wide review of postnatal care in Victoria, Australia

    PubMed Central

    Forster, Della A; McLachlan, Helen L; Yelland, Jane; Rayner, Jo; Lumley, Judith; Davey, Mary-Ann

    2006-01-01

    Background State-wide surveys of recent mothers conducted over the past decade in Victoria, one state of Australia, have identified that women are consistently less satisfied with the care they received in hospital following birth compared with other aspects of maternity care. Little is known of caregivers' perspectives on the provision ofhospital postnatal care: how care is organised and provided in different hospitals; what constrains the provision of postnatal care (apart from funding) and what initiatives are being undertaken to improve service delivery. A state-widereview of organisational structures and processes in relation to the provision of hospital postnatal care in Victoria was undertaken. This paper focuses on the impact of staffing issues on the provision of quality postnatal care from the perspective of care providers. Methods A study of care providers from Victorian public hospitals that provide maternity services was undertaken. Datawere collected in two stages. Stage one: a structured questionnaire was sent to all public hospitals in Victoria that provided postnatal care (n = 73), exploring the structure and organisation of care (e.g. staffing, routine observations, policy framework and discharge planning). Stage two: 14 maternity units were selected and invited to participate in a more in-depth exploration of postnatal care. Thirty-eight key informant interviews were undertaken with midwives (including unit managers, associate unit managers and clinical midwives) and a medical practitioner from eachselected hospital. Results Staffing was highlighted as a major factor impacting on the provision of quality postnatal care. There were significant issues associated with inadequate staff/patient ratios; staffing mix; patient mix; prioritisation of birth suites over postnatal units; and the use of non-permanent staff. Forty-three percent of hospitals reported having only midwives (i.e. no non-midwives) providing postnatal care. Staffing issues impact on

  8. Modeling and simulation in dose determination for biodefense products approved under the FDA animal rule.

    PubMed

    Bergman, Kimberly L; Krudys, K; Seo, S K; Florian, J

    2017-04-01

    Development of effective medical countermeasures for biodefense is vital to United States biopreparedness and response in the age of terrorism, both foreign and domestic. A traditional drug development pathway toward approval is not possible for most biodefense-related indications, creating the need for alternative development pathways such as the FDA's Animal Rule. Under this unique regulatory mechanism, FDA-approval is based on adequate and well-controlled animal studies when it is neither ethical nor feasible to conduct human efficacy studies. Translation of animal efficacy findings to humans is accomplished by use of modeling and simulation techniques. Pharmacokinetic and exposure-response modeling allow effective dosing regimens in humans to be identified, which are expected to produce similar benefit to that observed in animal models of disease. In this review, the role of modeling and simulation in determining the human dose for biodefense products developed under the Food and Drug Administration's Animal Rule regulatory pathway is discussed, and case studies illustrating the utility of modeling and simulation in this area of development are presented.

  9. FDA-approved neurologic devices intended for use in infants, children, and adolescents.

    PubMed

    Peña, Carlos; Bowsher, Kristen; Samuels-Reid, Joy

    2004-10-12

    The US Food and Drug Administration (FDA) has approved several applications for the marketing of neurologic devices. Nineteen high risk Class III medical devices were approved for the central and peripheral nervous system for marketing between 1994 and 2003, and almost half (n = 8) include indications for use in children as well as adults. On July 24, 2003, the FDA Center for Devices and Radiologic Health released for public comment a draft guidance document entitled "Premarket Assessment of Pediatric Medical Devices," which included in its objectives, the types of information needed to provide reasonable assurance of the safety and effectiveness of medical devices intended for use in children. The draft guidance document is also relevant to the types of information needed to promote the safe and effective development of neurologic devices. We review risk assessment and ways to reduce risk for neurologic devices intended for use in children. We also discuss the deep brain stimulator, the cochlear implant, and the CSF shunt, and considerations for minimizing risks associated with brain development, physical growth, surgery, and human factors.

  10. Doxil®--the first FDA-approved nano-drug: lessons learned.

    PubMed

    Barenholz, Yechezkel

    2012-06-10

    Doxil®, the first FDA-approved nano-drug (1995), is based on three unrelated principles: (i) prolonged drug circulation time and avoidance of the RES due to the use of PEGylated nano-liposomes; (ii) high and stable remote loading of doxorubicin driven by a transmembrane ammonium sulfate gradient, which also allows for drug release at the tumor; and (iii) having the liposome lipid bilayer in a "liquid ordered" phase composed of the high-T(m) (53 °C) phosphatidylcholine, and cholesterol. Due to the EPR effect, Doxil is "passively targeted" to tumors and its doxorubicin is released and becomes available to tumor cells by as yet unknown means. This review summarizes historical and scientific perspectives of Doxil development and lessons learned from its development and 20 years of its use. It demonstrates the obligatory need for applying an understanding of the cross talk between physicochemical, nano-technological, and biological principles. However, in spite of the large reward, ~2 years after Doxil-related patents expired, there is still no FDA-approved generic "Doxil" available.

  11. Guidance for pharmacogenomic biomarker testing in labels of FDA-approved drugs.

    PubMed

    Vivot, Alexandre; Boutron, Isabelle; Ravaud, Philippe; Porcher, Raphaël

    2015-09-01

    The aim of this study was to compare guidance for genetic testing in US Food and Drug Administration (FDA)-approved drug labels in oncology to those of drugs for other therapeutic areas. We reviewed labels of all the FDA-approved drugs with labels containing pharmacogenomic information. We assessed whether genetic testing was required or recommended before prescription and, if not, the reason for pharmacogenomic labeling. We included 140 drugs corresponding to 158 drug-biomarker pairs. Overall, 46 (29%) of 158 pairs stated a requirement or recommendation for genetic biomarker testing in the label. This proportion was higher in oncology than in other areas (62 vs. 12%; P < 0.001). For the 112 drug-biomarker pairs (including 20 in oncology) without recommendation or requirement for genetic testing, the main reasons for pharmacogenomic labeling were change in pharmacologic end points (32%) and higher risk of toxicity (30%). For 11 (10%) pairs (including 1 in oncology), a genetic biomarker was mentioned only to inform that it was not relevant. In oncology, the main reasons for pharmacogenomic labeling were higher risk of toxicity (55%) and definition of the mechanism of action (25%). Inclusion of biomarkers in drug labels does not always correspond to required or recommended genetic testing, especially outside oncology.Genet Med 17 9, 733-738.

  12. FDA guidance for ABSSSI trials: implications for conducting and interpreting clinical trials.

    PubMed

    Itani, Kamal M F; Shorr, Andrew F

    2014-01-01

    Recent guidance from the US Food and Drug Administration (FDA) on the conduct of clinical trials for acute bacterial skin and skin structure infection (ABSSSI) has changed the framework for clinical trial design and conduct. Notable changes included new disease state definitions, new primary endpoint definitions and the timing of assessments at these endpoints, and updated guidance on patient inclusion/exclusion criteria. Supportive evidence and statistical justification for the proposed noninferiority margins were described in detail. Although the updated guidelines are still considered drafts and have been adopted in some trials, they serve as the basis for study protocol discussions between pharmaceutical companies and the FDA in advancing the development of promising new agents. Not only will the new trial designs impact researchers and sponsors responsible for drug development programs, but they will also affect healthcare providers participating in clinical trials and the ways in which clinicians develop patient treatment plans based on the results of those trials. This review provides a summary of key changes that will impact future clinical trial design and outcomes.

  13. State-of-the-Art in Design Rules for Drug Delivery Platforms: Lessons from FDA-approved Nanomedicines

    PubMed Central

    Dawidczyk, Charlene M.; Kim, Chloe; Park, Jea Ho; Russell, Luisa M.; Lee, Kwan Hyi; Pomper, Martin G.; Searson, Peter C.

    2014-01-01

    The ability to efficiently deliver a drug to a tumor site is dependent on a wide range of physiologically imposed design constraints. Nanotechnology provides the possibility of creating delivery vehicles where these design constraints can be decoupled, allowing new approaches for reducing the unwanted side effects of systemic delivery, increasing targeting efficiency and efficacy. Here we review the design strategies of the two FDA-approved antibody-drug conjugates (Brentuximab vedotin and Trastuzumab emtansine) and the four FDA-approved nanoparticle-based drug delivery platforms (Doxil, DaunoXome, Marqibo, and Abraxane) in the context of the challenges associated with systemic targeted delivery of a drug to a solid tumor. The lessons learned from these nanomedicines provide important insight into the key challenges associated with the development of new platforms for systemic delivery of anti-cancer drugs. PMID:24874289

  14. State-of-the-art in design rules for drug delivery platforms: lessons learned from FDA-approved nanomedicines.

    PubMed

    Dawidczyk, Charlene M; Kim, Chloe; Park, Jea Ho; Russell, Luisa M; Lee, Kwan Hyi; Pomper, Martin G; Searson, Peter C

    2014-08-10

    The ability to efficiently deliver a drug to a tumor site is dependent on a wide range of physiologically imposed design constraints. Nanotechnology provides the possibility of creating delivery vehicles where these design constraints can be decoupled, allowing new approaches for reducing the unwanted side effects of systemic delivery, increasing targeting efficiency and efficacy. Here we review the design strategies of the two FDA-approved antibody-drug conjugates (Brentuximab vedotin and Trastuzumab emtansine) and the four FDA-approved nanoparticle-based drug delivery platforms (Doxil, DaunoXome, Marqibo, and Abraxane) in the context of the challenges associated with systemic targeted delivery of a drug to a solid tumor. The lessons learned from these nanomedicines provide an important insight into the key challenges associated with the development of new platforms for systemic delivery of anti-cancer drugs. Copyright © 2014 Elsevier B.V. All rights reserved.

  15. Statin-associated ocular disorders: the FDA and ADRAC data.

    PubMed

    Mizranita, Vinci; Pratisto, Eko Harry

    2015-10-01

    Statins are a class of medication indicated for atherosclerotic diseases and dyslipidemia. Since their appearance, many adverse events have been associated with their use. Ocular disorders are rare but serious adverse events of statins. To report the association between statins and ocular adverse events (blurred vision, visual impairment, visual field defect, reduced visual acuity, myopia, hypermetropia, presbyopia, and astigmatism) which might be associated with muscle or liver problems by examining the frequency of ocular adverse events among the reported adverse drug reactions from the Food and Drug Administration (FDA) and Adverse Drug Reactions Advisory Committee (ADRAC) data. Setting The FDA USA and ADRAC Australia databases. We conducted a retrospective study of statin-associated ocular adverse events reported to FDA between 1988 and 2013 and ADRAC between 1988 and 2011. The recoded data included: patient's age, gender, suspected drug and dosage, concomitant drug, adverse events, duration of therapy, dechallenge and rechallenge therapy. The differences in the adverse events profiles between each of the statins and atorvastatin were performed using Chi square and multivariate (logistic regression) statistical tests. Percentages of subjects correlated with each Ocular adverse events. Among 131,755 cases of patients taking statins in the FDA, there were 2325 cases reported ocular adverse events after using statins (1.8%). The Chi square statistic showed that the proportions of ocular adverse events varied significantly (p < 0.0001) across the different statin drugs. The most highly reported ocular adverse events associated with statins were blurred vision (48.4%) and visual impairment (25.7%). Results from logistic regression indicated that the ocular problems formed a greater proportion of the adverse events for subjects taking atorvastatin (2.1%). Of the 1.8%, ocular adverse events mostly occurred alone (60.9%), followed by 30.3% where muscle adverse events

  16. 75 FR 69089 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-10

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... for the Topical Approximation of Skin; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the...

  17. 76 FR 20992 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-14

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... subject to comment in accordance with the Agency's good guidance practices. DATES: Submit...

  18. 76 FR 77542 - Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... guidance for industry and FDA staff entitled ``Humanitarian Use Device (HUD) Designations.'' Devices are... HUD designation may be eligible for marketing approval under the Humanitarian Device Exemption...

  19. 76 FR 81511 - Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological Health Appeals Processes; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  20. 76 FR 51993 - Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-19

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion Diagnostic Devices; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. SUMMARY: The Food and Drug Administration (FDA...

  1. 78 FR 102 - Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-02

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the...

  2. FDA and EMA end points: which outcome end points should we use in clinical trials in patients with irritable bowel syndrome?

    PubMed

    Corsetti, M; Tack, J

    2013-06-01

    Trial design and endpoints for the evaluation of drug efficacy in irritable bowel syndrome (IBS) underwent major changes over the last two decades. A systematic review in the early 1990s concluded that there were few well-designed and well-executed treatment trials in IBS. Over the next decade, the so-called binary endpoints were used in several clinical trials in IBS in the US, Europe and other parts of the world. In 2006, the Food and Drug Administration (FDA) published a general guidance for the evaluation of symptom benefit in clinical trials based on patient-reported outcome (PRO) measures, which had a major impact on trial design in IBS. In May 2012, the FDA recommended to use as provisional endpoint the quantification of two major IBS aspects, abdominal pain and disordered defecation, to assess the efficacy of pharmacological treatments in IBS. In the present issue of Neurogastroenterology & Motility, the performance of the FDA Responder Endpoint for clinical trials in irritable bowel syndrome with constipation was evaluated using data from two large Phase III clinical trials of linaclotide. The FDA interim endpoints are clinically relevant as they are also able to capture the smallest patient-reported difference in the domain of Abdominal Pain intensity and Abnormal Defecation with good diagnostic accuracy. The FDA responder definition and the European Medicines Agency responder definitions generate similar response rates, while binary endpoints generate higher responder rates. The implications for optimalization and harmonisation are discussed.

  3. NIEHS/FDA CLARITY-BPA research program update.

    PubMed

    Heindel, Jerrold J; Newbold, Retha R; Bucher, John R; Camacho, Luísa; Delclos, K Barry; Lewis, Sherry M; Vanlandingham, Michelle; Churchwell, Mona I; Twaddle, Nathan C; McLellen, Michelle; Chidambaram, Mani; Bryant, Matthew; Woodling, Kellie; Gamboa da Costa, Gonçalo; Ferguson, Sherry A; Flaws, Jodi; Howard, Paul C; Walker, Nigel J; Zoeller, R Thomas; Fostel, Jennifer; Favaro, Carolyn; Schug, Thaddeus T

    2015-12-01

    Bisphenol A (BPA) is a chemical used in the production of numerous consumer products resulting in potential daily human exposure to this chemical. The FDA previously evaluated the body of BPA toxicology data and determined that BPA is safe at current exposure levels. Although consistent with the assessment of some other regulatory agencies around the world, this determination of BPA safety continues to be debated in scientific and popular publications, resulting in conflicting messages to the public. Thus, the National Toxicology Program (NTP), National Institute of Environmental Health Sciences (NIEHS), and U.S. Food and Drug Administration (FDA) developed a consortium-based research program to link more effectively a variety of hypothesis-based research investigations and guideline-compliant safety testing with BPA. This collaboration is known as the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA). This paper provides a detailed description of the conduct of the study and a midterm update on progress of the CLARITY-BPA research program.

  4. NIEHS/FDA CLARITY-BPA research program update

    PubMed Central

    Heindel, Jerrold J.; Newbold, Retha R.; Bucher, John R.; Camacho, Luísa; Delclos, K. Barry; Lewis, Sherry M.; Vanlandingham, Michelle; Churchwell, Mona I.; Twaddle, Nathan C.; McLellen, Michelle; Chidambaram, Mani; Bryant, Matthew; Woodling, Kellie; Gamboa da Costa, Gonçalo; Ferguson, Sherry A.; Flaws, Jodi; Howard, Paul C.; Walker, Nigel J.; Zoeller, R. Thomas; Fostel, Jennifer; Favaro, Carolyn; Schug, Thaddeus T.

    2016-01-01

    Bisphenol A (BPA) is a chemical used in the production of numerous consumer products resulting in potential daily human exposure to this chemical. The FDA previously evaluated the body of BPA toxicology data and determined that BPA is safe at current exposure levels. Although consistent with the assessment of some other regulatory agencies around the world, this determination of BPA safety continues to be debated in scientific and popular publications, resulting in conflicting messages to the public. Thus, the National Toxicology Program (NTP), National Institute of Environmental Health Sciences (NIEHS), and U.S Food and Drug Administration (FDA) developed a consortium-based research program to link more effectively a variety of hypothesis-based research investigations and guideline-compliant safety testing with BPA. This collaboration is known as the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA). This paper provides a detailed description of the conduct of the study and a midterm update on progress of the CLARITY-BPA research program. PMID:26232693

  5. FDA critical path initiatives: opportunities for generic drug development.

    PubMed

    Lionberger, Robert A

    2008-01-01

    FDA's critical path initiative documents have focused on the challenges involved in the development of new drugs. Some of the focus areas identified apply equally to the production of generic drugs. However, there are scientific challenges unique to the development of generic drugs as well. In May 2007, FDA released a document "Critical Path Opportunities for Generic Drugs" that identified some of the specific challenges in the development of generic drugs. The key steps in generic product development are usually characterization of the reference product, design of a pharmaceutically equivalent and bioequivalent product, design of a consistent manufacturing process and conduct of the pivotal bioequivalence study. There are several areas of opportunity where scientific progress could accelerate the development and approval of generic products and expand the range of products for which generic versions are available, while maintaining high standards for quality, safety, and efficacy. These areas include the use of quality by design to develop bioequivalent products, more efficient bioequivalence methods for systemically acting drugs (expansion of BCS waivers, highly variable drugs), and development of new bioequivalence methods for locally acting drugs.

  6. 77 FR 12086 - Final Staff Guidance, Revision 4 to Standard Review Plan; Section 8.1 on Electric Power-Introduction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-28

    ... Review of Safety Analysis Reports for Nuclear Power Plants,'' Standard Review Plan (SRP) Section 8.1 on... New Reactors, U.S. Nuclear Regulatory Commission, Washington, DC, 20555- 0001; telephone at 301-415... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY...

  7. Novel algorithms for improved pattern recognition using the US FDA Adverse Event Network Analyzer.

    PubMed

    Botsis, Taxiarchis; Scott, John; Goud, Ravi; Toman, Pamela; Sutherland, Andrea; Ball, Robert

    2014-01-01

    The medical review of adverse event reports for medical products requires the processing of "big data" stored in spontaneous reporting systems, such as the US Vaccine Adverse Event Reporting System (VAERS). VAERS data are not well suited to traditional statistical analyses so we developed the FDA Adverse Event Network Analyzer (AENA) and three novel network analysis approaches to extract information from these data. Our new approaches include a weighting scheme based on co-occurring triplets in reports, a visualization layout inspired by the islands algorithm, and a network growth methodology for the detection of outliers. We explored and verified these approaches by analysing the historical signal of Intussusception (IS) after the administration of RotaShield vaccine (RV) in 1999. We believe that our study supports the use of AENA for pattern recognition in medical product safety and other clinical data.

  8. 21 CFR 314.100 - Timeframes for reviewing applications and abbreviated applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.100 Timeframes for reviewing... application for a new drug under section 505(j) of the act, FDA will review it and send the applicant...

  9. Asthma education for school staff.

    PubMed

    Kew, Kayleigh M; Carr, Robin; Donovan, Tim; Gordon, Morris

    2017-04-12

    Teachers and school staff should be competent in managing asthma in schools. Demonstrated low levels of asthma knowledge mean that staff may not know how best to protect a child with asthma in their care, or may fail to take appropriate action in the event of a serious attack. Education about asthma could help to improve this knowledge and lead to better asthma outcomes for children. To assess the effectiveness and safety of asthma education programmes for school staff, and to identify content and attributes underpinning them. We conducted the most recent searches on 29 November 2016. We included randomised controlled trials comparing an intervention to educate school staff about asthma versus a control group. We included studies reported as full text, those published as abstract only and unpublished data. At least two review authors screened the searches, extracted outcome data and intervention characteristics from included studies and assessed risk of bias. Primary outcomes for the quantitative synthesis were emergency department (ED) or hospital visits, mortality and asthma control; we graded the main results and presented evidence in a 'Summary of findings' table. We planned a qualitative synthesis of intervention characteristics, but study authors were unable to provide the necessary information.We analysed dichotomous data as odds ratios, and continuous data as mean differences or standardised mean differences, all with a random-effects model. We assessed clinical, methodological and statistical heterogeneity when performing meta-analyses, and we narratively described skewed data. Five cluster-RCTs of 111 schools met the review eligibility criteria. Investigators measured outcomes in participating staff and often in children or parents, most often at between 1 and 12 months.All interventions were educational programmes but duration, content and delivery varied; some involved elements of training for pupils or primary care providers. We noted risk of selection

  10. Use staff wisely to save NHS money.

    PubMed

    Moore, Alison

    2015-12-09

    The NHS could save up to £ 2 billion a year by improving workflow and containing workforce costs, according to Labour peer Lord Carter's review of NHS efficiency. Changes in areas such as rostering and management of annual leave must avoid increasing the pressure on staff.

  11. Factors Affecting the Quality of Staff Development.

    ERIC Educational Resources Information Center

    Purcell, Larry O.

    A review of the literature concerning the effectiveness and quality of staff development programs focuses on factors that affect the success of such programs. These factors include: individual concerns, training activities, applications, qualifications of consultants, scheduling, strategies, facilities, feedback, collaboration, and outcomes. It is…

  12. Studies of Student and Staff Attitudes.

    ERIC Educational Resources Information Center

    Boggs, John R.

    1971-01-01

    This research review is concerned with affective measures that supplement other standard measures of achievement or biographical data for junior college students and staff. One instrument for measuring attitude is the Thurstone Method whose basic assumption is that a person's attitude is reflected by the opinions he endorses. Student attitudes and…

  13. Computer Training for Staff and Patrons.

    ERIC Educational Resources Information Center

    Krissoff, Alan; Konrad, Lee

    1998-01-01

    Describes a pilot computer training program for library staff and patrons at the University of Wisconsin-Madison. Reviews components of effective training programs and highlights core computer competencies: operating systems, hardware and software basics and troubleshooting, and search concepts and techniques. Includes an instructional outline and…

  14. The Staff of Life.

    ERIC Educational Resources Information Center

    Jones, Rebecca

    1994-01-01

    Some children have chronic illnesses that require diet modifications as part of their medical treatment. Advises school districts to hire a registered dietitian or look for resources at a local hospital or public health office. In addition, schools should work with parents, improve staff training, and conduct spot checks of school cafeterias. (MLF)

  15. Effective Staff Development.

    ERIC Educational Resources Information Center

    Bush, Robert N.

    Beginning with the observation that educators are faced with rising public expectations, declining resources, and increased public criticism, this paper describes a six-fold model for determining how staff development is operating and how it can be made to operate more effectively, in a self-renewing manner. The six dimensions consist of the…

  16. Battle Staff Integration

    DTIC Science & Technology

    1992-02-01

    This paper sets forth a research-based conceptual framework for understanding and addressing battle staff functioning and its relation to the...organizational theories and concepts is included, and the concept of team work and the characteristics of effective teams are discussed. A conceptual ... framework is presented for teamwork in problem-solving and decision-making activities within hierarchical organizations.

  17. Institutionalizing Staff Development.

    ERIC Educational Resources Information Center

    Shawl, William F.

    Three years ago, Golden West College (GWC) decided to make a major commitment to staff development as a means of revitalizing the college. This commitment was evidenced through the creation of the position of Dean of Educational Development, who is responsible solely for serving faculty needs; the Educational Development Center, which houses the…

  18. Readings in Staff Development.

    ERIC Educational Resources Information Center

    Southern Regional Education Board, Atlanta, GA.

    This book of readings is divided into two sections, each describing a specific aspect of staff development. There are three articles on planning in Section I. The quadrant arrangement developed in Georgia is described as one method of facilitating cooperation between an institution and the State Department of Education to serve a particular area…

  19. Staff Development and Evaluation.

    ERIC Educational Resources Information Center

    Dempsey, Richard A.; Breyer, Norman L.

    An ongoing behavioral model for implementing staff development and evaluation procedures is proposed, which systematically focuses on assessing and facilitating behavioral change in the classroom and enables the educational executive to assess what is actually happening there. The administrator is thus provided with the necessary information to…

  20. Ideas on Staff Motivation.

    ERIC Educational Resources Information Center

    Child Care Information Exchange, 1991

    1991-01-01

    Suggests the use of timely communication through feedback for the purpose of boosting staff morale. Managers can cause employees to motivate themselves by restructuring jobs to satisfy employees' needs, by using artful criticism, and by asking employees about morale. Includes a list of key ingredients of a satisfying job. (SH)

  1. Effective Staff Development.

    ERIC Educational Resources Information Center

    Bush, Robert N.

    Beginning with the observation that educators are faced with rising public expectations, declining resources, and increased public criticism, this paper describes a six-fold model for determining how staff development is operating and how it can be made to operate more effectively, in a self-renewing manner. The six dimensions consist of the…

  2. Listening to Staff.

    ERIC Educational Resources Information Center

    Davies, Peter; Owen, Jane

    Levels of staff satisfaction across the United Kingdom's post-16 sector were examined by distributing a questionnaire at more than 80 further education colleges. The questionnaire elicited 9,515 responses. Study participants rated 38 statements on a 4-point scale. The questions focused on the following areas: (1) faculty members' perceptions of…

  3. Staff Perception Survey.

    ERIC Educational Resources Information Center

    Quanty, Michael B.

    A staff survey was conducted at Thomas Nelson Community College (TNCC) to examine how those employed at the college view its major instructional and student support programs. Along with demographic questions, the survey explored perceptions of the college's programs, promotional activities, and work environment, and overall impressions of TNCC. In…

  4. Staff Development Needs Assessment.

    ERIC Educational Resources Information Center

    College of the Canyons, Valencia, CA. Office of Institutional Development.

    In September 1993, California's College of the Canyons surveyed a total of 415 faculty and staff regarding their satisfaction with their employment at the college and their perceptions of opportunities for development. Responses were received from 41% (n=170) of the employees, including 56 full-time and 58 part-time faculty and 41 full-time and 13…

  5. Evaluating Staff Development Schemes.

    ERIC Educational Resources Information Center

    Bradley, Judy

    1983-01-01

    There are three phases in the process of introducing and establishing staff development. They may be characterized as: What is it? How do we get started? and How well are we doing? Sooner or later, an interest in some form of evaluation is inevitable. (Author/SSH)

  6. Faculty and Staff Information.

    ERIC Educational Resources Information Center

    Kentucky Univ., Lexington. Community Coll. System.

    This booklet is intended to acquaint faculty and staff members with general information about the University of Kentucky community College System, and to explain some of its policies affecting them. The booklet is organized into five sections. Section I contains general information about the system, gives its history, purpose, and a map of the…

  7. Staff Development and Reading.

    ERIC Educational Resources Information Center

    Ediger, Marlow

    Much is being emphasized in staff development in the area of reading instruction. It is important for teachers to study and think reflectively about what can be done to improve the elementary reading curriculum. One procedure that can be used is to hold a quality workshop based on the needs of reading teachers. Teachers might volunteer to serve on…

  8. The Staff of Life.

    ERIC Educational Resources Information Center

    Jones, Rebecca

    1994-01-01

    Some children have chronic illnesses that require diet modifications as part of their medical treatment. Advises school districts to hire a registered dietitian or look for resources at a local hospital or public health office. In addition, schools should work with parents, improve staff training, and conduct spot checks of school cafeterias. (MLF)

  9. The Methodology of Clinical Studies Used by the FDA for Approval of High-Risk Orthopaedic Devices.

    PubMed

    Barker, Jordan P; Simon, Stephen D; Dubin, Jonathan

    2017-05-03

    The purpose of this investigation was to examine the methodology of clinical trials used by the U.S. Food and Drug Administration (FDA) to determine the safety and effectiveness of high-risk orthopaedic devices approved between 2001 and 2015. Utilizing the FDA's online public database, this systematic review audited study design and methodological variables intended to minimize bias and confounding. An additional analysis of blinding as well as the Checklist to Evaluate a Report of a Nonpharmacological Trial (CLEAR NPT) was applied to the randomized controlled trials (RCTs). Of the 49 studies, 46 (94%) were prospective and 37 (76%) were randomized. Forty-seven (96%) of the studies were controlled in some form. Of 35 studies that reported it, blinding was utilized in 21 (60%), of which 8 (38%) were reported as single-blinded and 13 (62%) were reported as double-blinded. Of the 37 RCTs, outcome assessors were clearly blinded in 6 (16%), whereas 15 (41%) were deemed impossible to blind as implants could be readily discerned on imaging. When the CLEAR NPT was applied to the 37 RCTs, >70% of studies were deemed "unclear" in describing generation of allocation sequences, treatment allocation concealment, and adequate blinding of participants and outcome assessors. This study manifests the highly variable reporting and strength of clinical research methodology accepted by the FDA to approve high-risk orthopaedic devices.

  10. High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices.

    PubMed

    Almond, Christopher S D; Chen, Eric A; Berman, Michael R; Less, Joanne R; Baldwin, J Timothy; Linde-Feucht, Sarah R; Hoke, Tracey R; Pearson, Gail D; Jenkins, Kathy; Duncan, Brian W; Zuckerman, Bram D

    2007-01-01

    Pediatric mechanical circulatory support is a critical unmet need in the United States. Infant- and child-sized ventricular assist devices are currently being developed largely through federal contracts and grants through the National Heart, Lung, and Blood Institute (NHLBI). Human testing and marketing of high-risk devices for children raises epidemiologic and regulatory issues that will need to be addressed. Leaders from the US Food and Drug Administration (FDA), NHLBI, academic pediatric community, and industry convened in January 2006 for the first FDA Workshop on the Regulatory Process for Pediatric Mechanical Circulatory Support Devices. The purpose was to provide the pediatric community with an overview of the federal regulatory process for high-risk medical devices and to review the challenges specific to the development and regulation of pediatric mechanical circulatory support devices. Pediatric mechanical circulatory support present significant epidemiologic, logistic, and financial challenges to industry, federal regulators, and the pediatric community. Early interactions with the FDA, shared appreciation of challenges, and careful planning will be critical to avoid unnecessary delays in making potentially life-saving devices available for children. Collaborative efforts to address these challenges are warranted.

  11. Medical staff appointment and delineation of pediatric privileges in hospitals.

    PubMed

    Rauch, Daniel A

    2012-04-01

    The review and verification of credentials and the granting of clinical privileges are required of every hospital to ensure that members of the medical staff are competent and qualified to provide specified levels of patient care. The credentialing process involves the following: (1) assessment of the professional and personal background of each practitioner seeking privileges; (2) assignment of privileges appropriate for the clinician's training and experience; (3) ongoing monitoring of the professional activities of each staff member; and (4) periodic reappointment to the medical staff on the basis of objectively measured performance. We examine the essential elements of a credentials review for initial and renewed medical staff appointments along with suggested criteria for the delineation of clinical privileges. Sample forms for the delineation of privileges can be found on the American Academy of Pediatrics Committee on Hospital Care Web site (http://www.aap.org/visit/cmte19.htm). Because of differences among individual hospitals, no 1 method for credentialing is universally applicable. The medical staff of each hospital must, therefore, establish its own process based on the general principles reviewed in this report. The issues of medical staff membership and credentialing have become very complex, and institutions and medical staffs are vulnerable to legal action. Consequently, it is advisable for hospitals and medical staffs to obtain expert legal advice when medical staff bylaws are constructed or revised.

  12. The disconnect between evidence and practice: a systematic review of person-centred interventions and training manuals for care home staff working with people with dementia.

    PubMed

    Fossey, Jane; Masson, Sarah; Stafford, Jane; Lawrence, Vanessa; Corbett, Anne; Ballard, Clive

    2014-08-01

    The overall objective is to determine the availability of person-centred intervention and training manuals for dementia care staff with clinical trial evidence of efficacy. Interventions were identified using a search of electronic databases, augmented by mainstream search engines, reference lists, hand searching for resources and consultation with an expert panel. The specific search for published manuals was complemented by a search for randomised control trials focussing on training and activity-based interventions for people with dementia in care homes. Manuals were screened for eligibility and rated to assess their quality, relevance and feasibility. A meta-analysis of randomised control trials indicated that person-centred training interventions conferred significant benefit in improving agitation and reducing the use of antipsychotics. Each of the efficacious packages included a sustained period of joint working and supervision with a trained mental health professional in addition to an educational element. However, of the 170 manuals that were identified, 30 met the quality criteria and only four had been evaluated in clinical trials. Despite the availability of a small number of evidence-based training manuals, there is a widespread use of person-centred intervention and training manuals that are not evidence-based. Clearer guidance is needed to ensure that commissioned training and interventions are based on robust evidence. Copyright © 2014 John Wiley & Sons, Ltd.

  13. FDA Should Reduce Expensive Antibiotic Testing and Charge Fees Which More Closely Reflect Cost of Certification.

    DTIC Science & Technology

    1981-10-28

    between 1970 and 1979 were not certified because of potency problems. GAO was told by two FDA officials that, except for nonsterile products , if...been low. Batch certification is an expensive product assurance strategy and other less costly control mecha- A nisms are available. Further, GAO...issuing of certificates for batches that pass the tests. Manufacturers may not market products subject to these tests until FDA certifies them. FDA charges

  14. 21 CFR 1.379 - How long may FDA detain an article of food?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false How long may FDA detain an article of food? 1.379 Section 1.379 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... Provisions § 1.379 How long may FDA detain an article of food? (a) FDA may detain an article of food for...

  15. Autologous cell therapies: challenges in US FDA regulation.

    PubMed

    McAllister, Todd N; Audley, David; L'Heureux, Nicolas

    2012-11-01

    Cell-based therapies (CBTs) have been hailed for the last two decades as the next pillar of healthcare, yet the clinical and commercial potential of regenerative medicine has yet to live up to the hype. While recent analysis has suggested that regenerative medicine is maturing into a multibillion dollar industry, examples of clinical and commercial success are still relatively rare. With 30 years of laboratory and clinical efforts fueled by countless billions in public and private funding, one must contemplate why CBTs have not made a greater impact. The current regulatory environment, with its zero-risk stance, stymies clinical innovation while fueling a potentially risky medical tourism industry. Here, we highlight the challenges the US FDA faces and present talking points for an improved regulatory framework for autologous CBTs.

  16. FDA, companies test RFID tracking to prevent drug counterfeiting.

    PubMed

    James, John S

    2005-12-01

    The U.S. has an apparently growing problem with fake, counterfeit drugs entering the mainstream drug supply, and being fraudulently sold at full price in regular pharmacies and hospitals; some have no active ingredient, or too little, or substitute a cheap drug for an expensive one. The FDA has asked drug manufacturers to develop technology to track all shipments electronically as they move through the distribution chain; currently, RFID (radio frequency identification) is the preferred method for doing so. This article explains what is happening, and why we do not believe that this use of RFID is a privacy threat--though other privacy issues are among the most important questions we face today.

  17. An analysis of FDA-approved drugs for oncology.

    PubMed

    Kinch, Michael S

    2014-12-01

    Cancer remains the second leading cause of death globally. The number of new medicines targeting cancer has grown impressively since the 1990s. On average, ten new drugs are introduced each year. Such growth has partly been achieved by emphasizing biologics and orphan indications, which account for one-quarter and one-half of new oncology drugs, respectively. The biotechnology industry likewise has become the primary driver of cancer drug development in terms of patents, preclinical and clinical research, although pharmaceutical companies are granted more FDA approvals. Many targeting strategies have been successful but recent trends suggest that kinase targets, although tractable, might be overemphasized. Copyright © 2014 Elsevier Ltd. All rights reserved.

  18. Repurposing FDA-approved drugs for anti-aging therapies.

    PubMed

    Snell, Terry W; Johnston, Rachel K; Srinivasan, Bharath; Zhou, Hongyi; Gao, Mu; Skolnick, Jeffrey

    2016-11-01

    There is great interest in drugs that are capable of modulating multiple aging pathways, thereby delaying the onset and progression of aging. Effective strategies for drug development include the repurposing of existing drugs already approved by the FDA for human therapy. FDA approved drugs have known mechanisms of action and have been thoroughly screened for safety. Although there has been extensive scientific activity in repurposing drugs for disease therapy, there has been little testing of these drugs for their effects on aging. The pool of FDA approved drugs therefore represents a large reservoir of drug candidates with substantial potential for anti-aging therapy. In this paper we employ FINDSITE(comb), a powerful ligand homology modeling program, to identify binding partners for proteins produced by temperature sensing genes that have been implicated in aging. This list of drugs with potential to modulate aging rates was then tested experimentally for lifespan and healthspan extension using a small invertebrate model. Three protein targets of the rotifer Brachionus manjavacas corresponding to products of the transient receptor potential gene 7, ribosomal protein S6 polypeptide 2 gene, or forkhead box C gene, were screened against a compound library consisting of DrugBank drugs including 1347 FDA approved, non-nutraceutical molecules. Twenty nine drugs ranked in the top 1 % for binding to each target were subsequently included in our experimental analysis. Continuous exposure of rotifers to 1 µM naproxen significantly extended rotifer mean lifespan by 14 %. We used three endpoints to estimate rotifer health: swimming speed (mobility proxy), reproduction (overall vitality), and mitochondria activity (cellular senescence proxy). The natural decline in swimming speed with aging was more gradual when rotifers were exposed to three drugs, so that on day 6, mean swimming speed of females was 1.19 mm/s for naproxen (P = 0.038), 1.20 for fludarabine (P = 0

  19. Large Eddy Simulation of FDA's Idealized Medical Device.

    PubMed

    Delorme, Yann T; Anupindi, Kameswararao; Frankel, Steven H

    2013-12-01

    A hybrid large eddy simulation (LES) and immersed boundary method (IBM) computational approach is used to make quantitative predictions of flow field statistics within the Food and Drug Administration's (FDA) idealized medical device. An in-house code is used, hereafter (W enoHemo(™) ), that combines high-order finite-difference schemes on structured staggered Cartesian grids with an IBM to facilitate flow over or through complex stationary or rotating geometries and employs a subgrid-scale (SGS) turbulence model that more naturally handles transitional flows [2]. Predictions of velocity and wall shear stress statistics are compared with previously published experimental measurements from Hariharan et al. [6] for the four Reynolds numbers considered.

  20. Disparities in Discontinuing Rosiglitazone Following the 2007 FDA Safety Alert

    PubMed Central

    Qato, Danya M.; Trivedi, Amal N.; Mor, Vincent; Dore, David D.

    2016-01-01

    Background Responsiveness to the Food and Drug Administration (FDA) rosiglitazone safety alert, issued on May 21, 2007, has not been examined among vulnerable subpopulations of the elderly. Objective To compare time to discontinuation of rosiglitazone after the safety alert between black and white elderly persons, and across sociodemographic and economic subgroups. Research Design A cohort study. Subjects Medicare fee-for-service enrollees in 2007 who were established users of rosiglitazone identified from a 20% national sample of pharmacy claims. Measures Outcome of interest was time to discontinuation of rosiglitazone after the May alert. We modeled the number of days following the warning to the end of the days’ supply for the last rosiglitazone claim during the study period (May 21, 2007–December 31, 2007) using multivariable proportional hazards models. Results More than 67% of enrollees discontinued rosiglitazone within six months of the advisory. In adjusted analysis, white enrollees (hazard ratio = 0.90; 95% confidence interval, 0.86–0.94) discontinued rosiglitazone later than the comparison group of black enrollees. Enrollees with a history of low personal income also discontinued later than their comparison group (hazard ratio = 0.84; 95% confidence interval, 0.81–0.87). There were no observed differences across quintiles of area-level socioeconomic status. Conclusions White race and a history of low personal income modestly predicted later discontinuation of rosiglitazone after the FDA’s safety advisory in 2007. The impact of FDA advisories can vary among sociodemographic groups. Policymakers should continue to monitor whether risk management policies reach their intended populations. PMID:26978569

  1. The FDA's new advice on fish: it's complicated.

    PubMed

    Wenstrom, Katharine D

    2014-11-01

    The Food and Drug Administration and Environmental Protection Agency recently issued an updated draft of advice on fish consumption for pregnant and breastfeeding women, after survey data indicated that the majority of pregnant women do not eat much fish and thus may have inadequate intake of the omega 3 fatty acids eicosapentaenoic acid [EPA] and ducosahexaenoic acid [DHA]. Omega 3 fatty acids are essential components of membranes in all cells of the body and are vitally important for normal development of the brain and retinal tissues (especially myelin and retinal photoreceptors) and for maintenance of normal neurotransmission and connectivity. They also serve as substrates for the synthesis of a variety of antiinflammatory and inflammation-resolving mediators, favorably alter the production of thromboxane and prostaglandin E2, and improve cardiovascular health by preventing fatal arrhythmias and reducing triglyceride and C-reactive protein levels. Maternal ingestion of adequate quantities of fish (defined in many studies as at least 340 g of oily fish each week) has been associated with better childhood IQ scores, fine motor coordination, and communication and social skills, along with other benefits. Although the FDA did not clarify which fish to eat, it specifically advised against eating fish with the highest mercury levels and implied that fish with high levels of EPA and DHA and low levels of mercury are ideal. The FDA draft did not recommend taking omega 3 fatty acid or fish oil supplements instead of eating fish, which is advice that may reflect the fact that randomized controlled trials of DHA and EPA or fish oil supplementation generally have been disappointing and that the ideal daily dose of DHA and EPA is unknown. It seems safe to conclude that pregnant and nursing women should be advised to eat fish to benefit from naturally occurring omega 3 fatty acids, to avoid fish with high levels of mercury and other contaminants, and, if possible, to choose

  2. Revocation of regulation on positron emission tomography drug products--FDA. Final rule; revocation.

    PubMed

    1997-12-19

    The Food and Drug Administration (FDA) is revoking a regulation on positron emission tomography (PET) radiopharmaceutical drug products. The regulation permits FDA to approve requests from manufacturers of PET drugs for exceptions or alternatives to provisions of the current good manufacturing practice (CGMP) regulations. FDA is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (Modernization Act). Elsewhere in this issue of the Federal Register, FDA is publishing a notice revoking two notices concerning certain guidance documents on PET drugs and the guidance documents to which the notices relate.

  3. 10 CFR 52.143 - Staff approval of design.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... the design in the form of a report available at the NRC Web site, http://www.nrc.gov. ... 10 Energy 2 2011-01-01 2011-01-01 false Staff approval of design. 52.143 Section 52.143 Energy... Standard Design Approvals § 52.143 Staff approval of design. Upon completion of its review of a submittal...

  4. 10 CFR 52.143 - Staff approval of design.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... the design in the form of a report available at the NRC Web site, http://www.nrc.gov. ... 10 Energy 2 2010-01-01 2010-01-01 false Staff approval of design. 52.143 Section 52.143 Energy... Standard Design Approvals § 52.143 Staff approval of design. Upon completion of its review of a submittal...

  5. 10 CFR 52.143 - Staff approval of design.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... the design in the form of a report available at the NRC Web site, http://www.nrc.gov. ... 10 Energy 2 2012-01-01 2012-01-01 false Staff approval of design. 52.143 Section 52.143 Energy... Standard Design Approvals § 52.143 Staff approval of design. Upon completion of its review of a submittal...

  6. Preemption of the "fraud on the FDA" exception to Michigan's tort immunity statute for drug manufacturers: reconsidering Garcia and Desiano after Levine.

    PubMed

    Murdey, Jason

    2011-01-01

    In Buckman v. Plaintiff's Legal Committee, the Supreme Court of the United States held that "fraud on FDA" claims in medical device products liability actions were impliedly preempted by the Medical Device Amendments to the Food, Drug, and Cosmetic Act (FDCA). A Michigan statute that provides a complete regulatory compliance defense for drug manufacturers, absent a finding that the manufacturer defrauded or bribed the FDA. The Sixth Circuit found that the statute's fraud exception was preempted under Buckman, extending Buckman's holding to traditional products liability claims with circumstances involving fraud on the FDA. The Second Circuit reached the opposite conclusion in interpreting the same statute, confining Buckman to its narrow holding, preempting stand-alone fraud on the FDA claims while carving out a space for traditional state tort claims. The Supreme Court left the issue unresolved in its review of the Second Circuit, splitting 4-4. Since then, the great majority of courts have followed the Sixth Circuit's holding. This situation has created serious questions about the ability of Michigan citizens to obtain any relief in an action against a drug manufacturer. The Supreme Court recently refused to find blanket implied preemption for failure-to-warn claims involving prescription drugs in Wyeth v. Levine, holding that "common-law claims do not stand as an obstacle to the accomplishment of Congress's purposes in the FDCA." This holding casts serious doubt on the continued vitality of implied preemption in drug and device litigation, and could, and should, lead to a reexamination of the application of Buckman to traditional products liability claims against drug manufacturers from Michigan plaintiffs in circumstances that involve, inter alia, fraud on the FDA. The next time this application is considered, the court should allow plaintiffs to present evidence tending to show fraud on the FDA in rebutting the manufacturer's presumptive immunity under the

  7. Controlling the Costs of Education in Eastern Africa: A Review of Data, Issues, and Policies. World Bank Staff Working Papers No. 702.

    ERIC Educational Resources Information Center

    Wolff, Laurence

    Data and issues on costs of primary, secondary, and higher education in Eastern Africa are presented. Practical recommendations for controlling or reducing costs while paying attention to effects on quality and equity are made. For each level of education the report reviews student-teacher ratios, teacher salaries, non-teaching costs, and…

  8. Staff Specialist Survival Course

    DTIC Science & Technology

    2016-03-01

    51 Defense AT&L: March-April 2016 Staff Specialist Survival Course Peter Czech Czech is a professor of Program Management in the Defense Systems... Management College’s School of Program Management at the Defense Acquisition University, Fort Belvoir, Virginia. He previously worked for the...Defense System Manage - ment College, located on the Fort Belvoir, Virginia, campus of the Defense Acquisition University, offers a course

  9. Racial/Ethnic composition of study participants in FDA-approved oncology new molecular entities, 2006-2008.

    PubMed

    Merenda, Christine

    2012-01-01

    The US Food and Drug Administration (FDA) has an ongoing interest in identifying the race/ethnicity of clinical trial participants to ensure they are representative of the people who will use the products once they are approved, and differences in response to medical products have already been observed in racial/ethnic subgroups of the US population. As a result, we reviewed the racial/ethnic composition of study participants in clinical trials of FDA-approved oncology products. Oncology products were chosen because of the disparate incidence and impact of cancer in racial/ethnic communities. New Drug and Biologics Licensing Application databases were searched for new molecular entity (NME) approvals for oncologic treatment from January 1, 2006, through December 31, 2008. We then reviewed NME applications for the pivotal Phase II and III trials used for approval decisions. We then compared the racial/ethnic composition results from the recent trials with those conducted earlier. We also assessed FDA-approved labeling to determine the extent to which race-based findings were included. US participants averaged 20.3% (range, 11%-97%) of the total participants in the studies reviewed. A comparison of the racial/ ethnic composition showed the participation of whites and blacks or African Americans have decreased, while that of Latinos, Asians, and Native Hawaiians/Pacific Islanders has increased. The results suggest better attention to compliance with collection and reporting, as the percentage of US study participants whose race and/or ethnicity could not be determined decreased from 31% to < 1%. With respect to product labeling, the current study found 6 (60%) included race-based findings.

  10. Staff training and challenging behaviour: who needs it?

    PubMed

    Campbell, Martin

    2007-06-01

    Staff working directly with people who have challenging behaviour in learning disability services need to be D good at what they do. These staff are trained by their employers to manage and to treat challenging behaviours and to improve the quality of life of people in their care. While such training is generally well evaluated by care staff, there is limited evidence that training alone changes poor attitudes or improves staff performance. Training has not been linked to quality of outcomes for service users. From research on treating challenging behaviour, achieving maintenance of behavioural gains after treatment has been discontinued is the exception rather than the rule. Can the same be said for maintaining gains achieved through staff training in the area of challenging behaviour? This discussion article reviews the value of training for staff working with people with challenging behaviour.

  11. 77 FR 14401 - Draft Guidance on Drug Safety Information-FDA's Communication to the Public; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance on Drug Safety Information--FDA's Communication to the Public; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance...

  12. 21 CFR 830.220 - Termination of FDA service as an issuing agency.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Termination of FDA service as an issuing agency. 830.220 Section 830.220 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... be likely to lead to a return of the conditions that prompted us to act. (b) If FDA has ended...

  13. 21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Utilization of an advisory committee on the initiative of FDA. 14.171 Section 14.171 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Human Prescription Drugs § 14.171 Utilization of an advisory committee on the initiative of FDA. (a) Any...

  14. 21 CFR 516.34 - FDA recognition of exclusive marketing rights.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false FDA recognition of exclusive marketing rights. 516... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.34 FDA recognition of exclusive...

  15. 21 CFR 516.34 - FDA recognition of exclusive marketing rights.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false FDA recognition of exclusive marketing rights. 516... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.34 FDA recognition of exclusive...

  16. 21 CFR 516.34 - FDA recognition of exclusive marketing rights.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false FDA recognition of exclusive marketing rights. 516... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.34 FDA recognition of exclusive...

  17. 76 FR 34715 - Draft Guidance for Industry; Considering Whether an FDA-Regulated Product Involves the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-14

    ...-Regulated Product Involves the Application of Nanotechnology; Availability AGENCY: Food and Drug... the Application of Nanotechnology''. This guidance is intended to provide industry with FDA's current... nanotechnology. The points to consider are intended to be broadly applicable to all FDA-regulated products, with...

  18. FDA Procedures for Standardization and Certification of Retail Food Inspection/Training Officers, 2000.

    ERIC Educational Resources Information Center

    Food and Drug Administration (DHHS/PHS), Rockville, MD.

    This document provides information, standards, and behavioral objectives for standardization and certification of retail food inspection personnel in the Food and Drug Administration (FDA). The procedures described in the document are based on the FDA Food Code, updated to reflect current Food Code provisions and to include a more refined focus on…

  19. The FDA's failure to address the lack of generalisability of antidepressant efficacy trials in product labelling.

    PubMed

    Zimmerman, Mark

    2016-06-01

    According to the US Food and Drug Administration's (FDA's) regulations, the criteria used to select patients into registration studies should be addressed in a product's label. The FDA's labelling guidelines, which specifically indicate that the routine exclusion of patients of a certain level of severity should be noted in the label, has been uniformly ignored. © The Royal College of Psychiatrists 2016.

  20. 10 CFR 35.7 - FDA, other Federal, and State requirements.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false FDA, other Federal, and State requirements. 35.7 Section 35.7 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Information § 35.7 FDA, other Federal, and State requirements. Nothing in this part relieves the licensee...

  1. 10 CFR 35.7 - FDA, other Federal, and State requirements.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false FDA, other Federal, and State requirements. 35.7 Section 35.7 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Information § 35.7 FDA, other Federal, and State requirements. Nothing in this part relieves the licensee...

  2. 10 CFR 35.7 - FDA, other Federal, and State requirements.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false FDA, other Federal, and State requirements. 35.7 Section 35.7 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Information § 35.7 FDA, other Federal, and State requirements. Nothing in this part relieves the licensee...

  3. 10 CFR 35.7 - FDA, other Federal, and State requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false FDA, other Federal, and State requirements. 35.7 Section 35.7 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Information § 35.7 FDA, other Federal, and State requirements. Nothing in this part relieves the licensee...

  4. 10 CFR 35.7 - FDA, other Federal, and State requirements.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false FDA, other Federal, and State requirements. 35.7 Section 35.7 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Information § 35.7 FDA, other Federal, and State requirements. Nothing in this part relieves the licensee...

  5. 21 CFR 4.2 - How does FDA define key terms and phrases in this subpart?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false How does FDA define key terms and phrases in this... Combination Products § 4.2 How does FDA define key terms and phrases in this subpart? The terms listed in this section have the following meanings for purposes of this subpart: Biological product has the meaning set...

  6. 21 CFR 4.2 - How does FDA define key terms and phrases in this subpart?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false How does FDA define key terms and phrases in this... Combination Products § 4.2 How does FDA define key terms and phrases in this subpart? The terms listed in this section have the following meanings for purposes of this subpart: Biological product has the meaning set...

  7. 21 CFR 516.34 - FDA recognition of exclusive marketing rights.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false FDA recognition of exclusive marketing rights. 516... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.34 FDA recognition of...

  8. 76 FR 38666 - Food and Drug Administration (FDA) and Marine Environmental Sciences Consortium/Dauphin Island...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-01

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration (FDA) and Marine Environmental Sciences Consortium/Dauphin Island Sea Lab Collaboration (U19) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of...

  9. Development of a Course of Study in FDA Drug Regulatory Procedures

    ERIC Educational Resources Information Center

    Jacobs, Robin Wills; King, James C.

    1977-01-01

    It is evident that more colleges of pharmacy should establish some major course of study in the area of governmental drug regulatory procedures. This study is aimed at expanding cooperative educational programs through an FDA residency for pharmacy students and preparing a didactic course in FDA procedures. (LBH)

  10. 21 CFR 1271.27 - Will FDA assign me a registration number?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Section 1271.27 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES..., TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Procedures for Registration and Listing § 1271.27 Will FDA assign me a registration number? (a) FDA will assign each location a permanent registration number....

  11. A Systematic Review and Meta-Analysis of a Measure of Staff/Child Interaction Quality (the Classroom Assessment Scoring System) in Early Childhood Education and Care Settings and Child Outcomes

    PubMed Central

    Perlman, Michal; Falenchuk, Olesya; Fletcher, Brooke; McMullen, Evelyn; Beyene, Joseph; Shah, Prakesh S.

    2016-01-01

    The quality of staff/child interactions as measured by the Classroom Assessment Scoring System (CLASS) in Early Childhood Education and Care (ECEC) programs is thought to be important for children’s outcomes. The CLASS is made of three domains that assess Emotional Support, Classroom Organization and Instructional Support. It is a relatively new measure that is being used increasingly for research, quality monitoring/accountability and other applied purposes. Our objective was to evaluate the association between the CLASS and child outcomes. Searches of Medline, PsycINFO, ERIC, websites of large datasets and reference sections of all retrieved articles were conducted up to July 3, 2015. Studies that measured association between the CLASS and child outcomes for preschool-aged children who attended ECEC programs were included after screening by two independent reviewers. Searches and data extraction were conducted by two independent reviewers. Thirty-five studies were systematically reviewed of which 19 provided data for meta-analyses. Most studies had moderate to high risk of bias. Of the 14 meta-analyses we conducted, associations between Classroom Organization and Pencil Tapping and between Instructional Support and SSRS Social Skills were significant with pooled correlations of .06 and .09 respectively. All associations were in the expected direction. In the systematic review, significant correlations were reported mainly from one large dataset. Substantial heterogeneity in use of the CLASS, its dimensions, child outcomes and statistical measures was identified. Greater consistency in study methodology is urgently needed. Given the multitude of factors that impact child development it is encouraging that our analyses revealed some, although small, associations between the CLASS and children’s outcomes. PMID:28036333

  12. A Systematic Review and Meta-Analysis of a Measure of Staff/Child Interaction Quality (the Classroom Assessment Scoring System) in Early Childhood Education and Care Settings and Child Outcomes.

    PubMed

    Perlman, Michal; Falenchuk, Olesya; Fletcher, Brooke; McMullen, Evelyn; Beyene, Joseph; Shah, Prakesh S

    2016-01-01

    The quality of staff/child interactions as measured by the Classroom Assessment Scoring System (CLASS) in Early Childhood Education and Care (ECEC) programs is thought to be important for children's outcomes. The CLASS is made of three domains that assess Emotional Support, Classroom Organization and Instructional Support. It is a relatively new measure that is being used increasingly for research, quality monitoring/accountability and other applied purposes. Our objective was to evaluate the association between the CLASS and child outcomes. Searches of Medline, PsycINFO, ERIC, websites of large datasets and reference sections of all retrieved articles were conducted up to July 3, 2015. Studies that measured association between the CLASS and child outcomes for preschool-aged children who attended ECEC programs were included after screening by two independent reviewers. Searches and data extraction were conducted by two independent reviewers. Thirty-five studies were systematically reviewed of which 19 provided data for meta-analyses. Most studies had moderate to high risk of bias. Of the 14 meta-analyses we conducted, associations between Classroom Organization and Pencil Tapping and between Instructional Support and SSRS Social Skills were significant with pooled correlations of .06 and .09 respectively. All associations were in the expected direction. In the systematic review, significant correlations were reported mainly from one large dataset. Substantial heterogeneity in use of the CLASS, its dimensions, child outcomes and statistical measures was identified. Greater consistency in study methodology is urgently needed. Given the multitude of factors that impact child development it is encouraging that our analyses revealed some, although small, associations between the CLASS and children's outcomes.

  13. The FDA and genetic testing: improper tools for a difficult problem

    PubMed Central

    Willmarth, Kirk

    2015-01-01

    The US Food and Drug Administration (FDA) has recently issued draft guidance on how it intends to regulate laboratory-developed tests, including genetic tests. This article argues that genetic tests differ from traditional targets of FDA regulation in both product as well as industry landscape, and that the FDA's traditional tools are ill-suited for regulating this space. While existing regulatory gaps do create risks in genetic testing, the regulatory burden of the FDA's proposal introduces new risks for both test providers and patients that may offset the benefits. Incremental expansion of current oversight outside of the FDA can mitigate many of the risks necessitating increased oversight while avoiding the creation of new ones that could undermine this industry. PMID:27774193

  14. The FDA and genetic testing: improper tools for a difficult problem.

    PubMed

    Willmarth, Kirk

    2015-02-01

    The US Food and Drug Administration (FDA) has recently issued draft guidance on how it intends to regulate laboratory-developed tests, including genetic tests. This article argues that genetic tests differ from traditional targets of FDA regulation in both product as well as industry landscape, and that the FDA's traditional tools are ill-suited for regulating this space. While existing regulatory gaps do create risks in genetic testing, the regulatory burden of the FDA's proposal introduces new risks for both test providers and patients that may offset the benefits. Incremental expansion of current oversight outside of the FDA can mitigate many of the risks necessitating increased oversight while avoiding the creation of new ones that could undermine this industry.

  15. FDA-Approved Natural Polymers for Fast Dissolving Tablets

    PubMed Central

    Alam, Md Tausif; Parvez, Nayyar; Sharma, Pramod Kumar

    2014-01-01

    Oral route is the most preferred route for administration of different drugs because it is regarded as safest, most convenient, and economical route. Fast disintegrating tablets are very popular nowadays as they get dissolved or facilely disintegrated in mouth within few seconds of administration without the need of water. The disadvantages of conventional dosage form, especially dysphagia (arduousness in swallowing), in pediatric and geriatric patients have been overcome by fast dissolving tablets. Natural materials have advantages over synthetic ones since they are chemically inert, non-toxic, less expensive, biodegradable and widely available. Natural polymers like locust bean gum, banana powder, mango peel pectin, Mangifera indica gum, and Hibiscus rosa-sinenses mucilage ameliorate the properties of tablet and utilized as binder, diluent, and superdisintegrants increase the solubility of poorly water soluble drug, decrease the disintegration time, and provide nutritional supplement. Natural polymers are obtained from the natural origin and they are cost efficacious, nontoxic, biodegradable, eco-friendly, devoid of any side effect, renewable, and provide nutritional supplement. It is proved from the studies that natural polymers are more safe and efficacious than the synthetic polymers. The aim of the present article is to study the FDA-approved natural polymers utilized in fast dissolving tablets. PMID:26556207

  16. The FDA role in contact lens development and safety.

    PubMed

    Lippman, R E

    1990-01-01

    The Food and Drug Administration (FDA) exercises a multifaceted role in fulfilling its mission of enforcing the Federal Food, Drug and Cosmetic Act (Act), functioning not only as industry regulator and consumer protector, but also as scientific advisor and consumer educator regarding medical devices, drugs, foods, cosmetics, and veterinary medicine. Medical devices are regulated within the Center for Devices and Radiological Health. Contact lenses are regulated under the authority of the medical device amendments. The Center is responsible for promulgating regulations, publishing guidelines, and developing written guidance in enforcing the Act, and also for guiding manufacturers of medical devices in safe and effective product development. Other components deal with the compliance of manufacturers with the marketing of medical devices within the meaning of the Act, and through labeling requirements of the Act and consumer education and informational activities. As for contact lenses, the process of updating product development regulations and guidelines is an ongoing activity. The most recent version of the Contact Lens Guideline Document, issued in April 1988, contains two major revisions involving preclinical and clinical testing. The first redefines plastics into one materials category, thus reducing testing requirements with respect to animal toxicology studies and other preclinical areas. The second revision restricts clinical testing requirements to allow confirmatory trials in applications for new daily wear lenses. The intention was to maintain the ability of studies to detect major material or design flaws in lenses, thus boosting confidence in their performance while eliminating unnecessary trials.(ABSTRACT TRUNCATED AT 250 WORDS)

  17. FDA-Approved Natural Polymers for Fast Dissolving Tablets.

    PubMed

    Alam, Md Tausif; Parvez, Nayyar; Sharma, Pramod Kumar

    2014-01-01

    Oral route is the most preferred route for administration of different drugs because it is regarded as safest, most convenient, and economical route. Fast disintegrating tablets are very popular nowadays as they get dissolved or facilely disintegrated in mouth within few seconds of administration without the need of water. The disadvantages of conventional dosage form, especially dysphagia (arduousness in swallowing), in pediatric and geriatric patients have been overcome by fast dissolving tablets. Natural materials have advantages over synthetic ones since they are chemically inert, non-toxic, less expensive, biodegradable and widely available. Natural polymers like locust bean gum, banana powder, mango peel pectin, Mangifera indica gum, and Hibiscus rosa-sinenses mucilage ameliorate the properties of tablet and utilized as binder, diluent, and superdisintegrants increase the solubility of poorly water soluble drug, decrease the disintegration time, and provide nutritional supplement. Natural polymers are obtained from the natural origin and they are cost efficacious, nontoxic, biodegradable, eco-friendly, devoid of any side effect, renewable, and provide nutritional supplement. It is proved from the studies that natural polymers are more safe and efficacious than the synthetic polymers. The aim of the present article is to study the FDA-approved natural polymers utilized in fast dissolving tablets.

  18. Dissolution testing for generic drugs: an FDA perspective.

    PubMed

    Anand, Om; Yu, Lawrence X; Conner, Dale P; Davit, Barbara M

    2011-09-01

    In vitro dissolution testing is an important tool used for development and approval of generic dosage forms. The objective of this article is to summarize how dissolution testing is used for the approval of safe and effective generic drug products in the United States (US). Dissolution testing is routinely used for stability and quality control purposes for both oral and non-oral dosage forms. The dissolution method should be developed using an appropriate validated method depending on the dosage form. There are several ways in which dissolution testing plays a pivotal role in regulatory decision-making. It may be used to waive in vivo bioequivalence (BE) study requirements, as BE documentation for Scale Up and Post Approval Changes (SUPAC), and to predict the potential for a modified-release (MR) drug product to dose-dump if co-administered with alcoholic beverages. Thus, in vitro dissolution testing plays a major role in FDA's efforts to reduce the regulatory burden and unnecessary human studies in generic drug development without sacrificing the quality of the drug products.

  19. Adherence of pharmaceutical advertisements in medical journals to FDA guidelines and content for safe prescribing.

    PubMed

    Korenstein, Deborah; Keyhani, Salomeh; Mendelson, Ali; Ross, Joseph S

    2011-01-01

    Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA); adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing. Cross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1-14). Six "teaser" advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1%) adhered to all FDA guidelines, 41 (49.4%) were non-adherent with at least one form of FDA-described bias, and 27 (32.5%) were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence. Few physician-directed print pharmaceutical advertisements

  20. The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States.

    PubMed

    Gupta, Ravi; Dhruva, Sanket S; Fox, Erin R; Ross, Joseph S

    2017-10-01

    Hundreds of drug products are currently marketed in the United States without approval from the FDA. The 2006 Unapproved Drugs Initiative (UDI) requires manufacturers to remove these drug products from the market or obtain FDA approval by demonstrating evidence of safety and efficacy. Once the FDA acts against an unapproved drug, fewer manufacturers remain in the market, potentially enabling drug price increases and greater susceptibility to drug shortages. There is a need for systematic study of the UDI's effect on prices and shortages of all targeted drugs. To examine the clinical evidence for approval and association with prices and shortages of previously unapproved prescription drugs after being addressed by the UDI. Previously unapproved prescription drugs that faced UDI regulatory action or with at least 1 product that received FDA approval through manufacturers' voluntary compliance with the UDI between 2006 and 2015 were identified. The clinical evidence was categorized as either newly conducted clinical trials or use of previously published literature and/or bioequivalence studies to demonstrate safety and efficacy. We determined the change in average wholesale price, presence of shortage, and duration of shortage for each drug during the 2 years before and after UDI regulatory action or approval through voluntary compliance. Between 2006 and 2015, 34 previously unapproved prescription drugs were addressed by the UDI. Nearly 90% of those with a drug product that received FDA approval were supported by literature reviews or bioequivalence studies, not new clinical trial evidence. Among the 26 drugs with available pricing data, average wholesale price during the 2 years before and after voluntary approval or UDI action increased by a median of 37% (interquartile range [IQR] = 23%-204%; P < 0.001). The number of drugs in shortage increased from 17 (50.0%) to 25 (73.5%) during the 2 years before and after, respectively (P = 0.046). The median shortage