Interview with Janet Woodcock: progress on the FDA's critical path initiative.

PubMed

Woodcock, Janet

2009-12-01

Janet Woodcock is the Director of the US FDA's Center for Drug Evaluation and Research. Dr Woodcock has held various positions within the FDA's Office of the Commissioner from October 2003 until 1 April, 2008, as Deputy Commissioner and Chief Medical Officer, Deputy Commissioner for Operations and Chief Operating Officer and Director of the Critical Path Programs. She oversaw scientific and medical regulatory operations for the FDA. Dr Woodcock served as Director of the Center for Drug Evaluation and Research at the FDA from 1994 to 2005. She previously served in other positions at the FDA including Director of the Office of Therapeutics Research and Review and Acting Deputy Director of the Center for Biologics Evaluation and Research. Dr Woodcock received her MD from Northwestern Medical School (IL, USA), and completed further training and held teaching appointments at the Pennsylvania State University (PA, USA)and the University of California in San Francisco (CA, USA). She joined the FDA in 1986.

Interview with Janet Woodcock.

PubMed

Woodcock, Janet

2010-09-01

Dr Janet Woodcock is the Director of the US FDA's Center for Drug Evaluation and Research. Dr Woodcock has held various positions within the FDA's Office of the Commissioner from October 2003 until 1 April 2008, as Deputy Commissioner and Chief Medical Officer, Deputy Commissioner for Operations and Chief Operating Officer and Director of the Critical Path Programs. She oversaw scientific and medical regulatory operations for the FDA. Dr Woodcock served as Director of the Center for Drug Evaluation and Research at the FDA from 1994 to 2005. She previously served in other positions at the FDA, including Director of the Office of Therapeutics Research and Review and Acting Deputy Director of the Center for Biologics Evaluation and Research. Dr Woodcock received her MD from Northwestern Medical School (IL, USA), and completed further training and held teaching appointments at the Pennsylvania State University (PA, USA) and the University of California in San Francisco (CA, USA). She joined the FDA in 1986.

The Regulatory Perspectives on Endoscopic Devices for Obesity.

PubMed

Marrone, April K; Antonino, Mark J; Silverstein, Joshua S; Betz, Martha W; Venkataraman-Rao, Priya; Golding, Martin; Cordray, Diane; Cooper, Jeffrey W

2017-04-01

The recent increase in US Food and Drug Administration-approved weight-loss devices has diversified obesity treatment options. The regulatory pathways for endoscopically placed weight-loss devices and considerations for clinical trials are discussed, including the benefit-risk paradigm intended to aid in weight-loss-device trial development. Also discussed is the benefit-risk analysis of recently approved endoscopic devices. A strategic priority of the FDA Center for Devices and Radiological Health is to increase the use of patient input in decision making. Thus, we consider how endoscopic weight-loss devices with profiles similar to those that have been approved may be viewed in a patient preference study. Published by Elsevier Inc.

Non-Ionizing Radiation Used in Microwave Ovens

MedlinePlus

... Human Services (HHS), U.S. Food and Drug Administration (FDA) FDA's Center for Devices and Radiological Health (CDRH) sets ... public health. These standards can be viewed on FDA's Code of Federal Regulations on Microwave Ovens . FDA ...

21 CFR 312.48 - Dispute resolution.

Code of Federal Regulations, 2010 CFR

2010-04-01

... division in FDA's Center for Drug Evaluation and Research or Center for Biologics Evaluation and Research which is responsible for review of the IND, beginning with the consumer safety officer assigned to the... director of the division in FDA's Center for Drug Evaluation and Research or Center for Biologics...

78 FR 18233 - Medical Devices; Technical Amendment

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-26

... the right column: Section Remove Add 814.20 http://www.fda.gov/ http://www.fda.gov/ cdrh/devadvice.../ PremarketApproval PMA/default.htm. 822.7 http://www.fda.gov/ http://www.fda.gov/ cdrh/ombudsman/ AboutFDA/ dispute.html. CentersOffices/ OfficeofMedicalPr oductsandTobacco/ CDRH/ CDRHOmbudsman/ default.htm. 822.15...

Paul Carlson | Center for Cancer Research

Cancer.gov

Paul Carlson, Ph.D. March 28 Principal Investigator Laboratory of Mucosal Pathogens and Cellular Immunology Center for Biologics Evaluation and Research (CBER), FDA Topic:  "Research and Regulation of novel biologic products at the FDA's Center for Biologics Evaluation and Research"

The Prescription Drug User Fee Act: Cause for Concern?

PubMed

Gabay, Michael

2018-04-01

The Prescription Drug User Fee Act (PDUFA) was originally enacted into law in 1992. PDUFA provides the Food and Drug Administration (FDA) with needed revenue in the form of various fees paid by drug and biologic manufacturers. The FDA utilizes this revenue to streamline the review and approval process for medications. Since the enactment of PDUFA, the median approval time for priority new drug applications and biologics license applications has reduced significantly. The FDA views PDUFA as a successful program that provides a consistent revenue stream to the agency, improves access to medications for patients, and allows industry to have a more predictable product review timeline. However, critics of PDUFA cite concerns including the potential for a lack of FDA independence and medication safety issues involving drugs approved after the existence of PDUFA.

75 FR 20913 - Center for Devices and Radiological Health; New Address Information

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-22

... information for the Center for Devices and Radiological Health (CDRH). All filings and other documents that... components of the agency's CDRH. The changes are the result of the relocation of these offices to FDA's White... with FDA Form 3500A. You may obtain the coding manual from CDRH's Web site at http://www.fda.gov/Safety...

FDA 101: Regulating Biological Products

MedlinePlus

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

Delegations of authority and organization; Center for Devices and Radiological Health--FDA. Final rule.

PubMed

1991-10-10

The Commissioner of Food and Drugs is redelegating authorities to certain officials of the Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH) to temporarily suspend premarket approval applications and to recall devices in the event those devices would cause serious adverse consequences to health or death. These authorities were given to the FDA by the Safe Medical Devices Act of 1990.

Delegations of authority and organization; Center for Devices and Radiological Health--FDA. Final rule.

PubMed

1994-06-17

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority relating to general redelegations of authority from the Associate Commissioner of Regulatory Affairs to certain FDA officials in the Center for Devices and Radiological Health (CDRH). The redelegation provides these officials with authority to grant or deny certain citizen petitions for exemption or variance from medical device tracking requirements. This action is being taken to facilitate expeditious handling of citizen petitions. FDA is also issuing a conforming amendment to the medical device tracking regulations to make the regulations consistent.

Dose Matters: FDA's Guidance on Children's X-rays

MedlinePlus

... Consumers Home For Consumers Consumer Updates Dose Matters: FDA's Guidance on Children's X-rays Share Tweet Linkedin ... extra care to “child size” the radiation dose. FDA’s Role The FDA's Center for Devices and Radiological ...

Center for Cancer Research plays key role in first FDA-approved drug for treatment of Merkel cell carcinoma | Center for Cancer Research

Cancer.gov

The Center for Cancer Research’s ability to rapidly deploy integrated basic and clinical research teams at a single site facilitated the rapid FDA approval of the immunotherapy drug avelumab for metastatic Merkel cell carcinoma, a rare, aggressive form of skin cancer. Learn more...  

The "natural" aversion: the FDA's reluctance to define a leading food-industry marketing claim, and the pressing need for a workable rule.

PubMed

Farris, April L

2010-01-01

As of 2009, the "natural foods" industry has become a 22.3 billion dollar giant and "all-natural" is the second-leading marketing claim for all new food products. Even in such a flourishing market, the Food and Drug Administration (FDA) has never defined the term "natural" through rulemaking. FDA and the U.S. Department of Agriculture (USDA) have instead created separate, non-identical policy statements governing the use of the term "natural," and FDA has abandoned efforts to define "natural" through rulemaking in the face of more pressing priorities. In absence of any governing federal standard, consumer advocacy groups and warring food industries have attempted to define "natural" to fit their preferences through high-stakes litigation of state law claims, leaving courts free to apply diverging standards without the expertise of FDA. Recent case law from federal district courts and the Supreme Court leaves little hope that FDA's current policy statement will preempt state law causes of action. To prevent a potential patchwork of definitions varying by state, and to create a legitimate standard resting on informed scientific expertise rather than consumer whims, FDA should engage in rulemaking to define the term "natural." This paper concludes by sketching potential formulations for such a rule based on FDA's previous successful rule-making ventures and standards used by natural foods retailers.

FDA working to ensure the safety of medical devices used in the pediatric population.

PubMed

Flack, Marilyn Neder; Gross, Thomas P; Reid, Joy Samuels; Mills, Thalia T; Francis, Jacqueline

2012-12-01

Special initiatives exist in FDA's Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research to ensure the safety and effectiveness of medical products used in the vulnerable pediatric population. This article focuses on the special programs, projects, and special studies implemented by CDRH to ensure this safety and effectiveness in devices used in pediatric patients throughout the devices' total product life-cycles. Pediatricians play a major role in keeping medical devices safe for use in children by reporting device problems to FDA. Published by Elsevier Inc.

36 CFR 13.970 - Frontcountry Developed Area definition.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Preserve Frontcountry Developed Area (fda) § 13.970 Frontcountry Developed Area definition. For purposes of this subpart, the Frontcountry Developed Area (FDA) means all park areas within the portion of the park... showing the FDA is available at the park visitor center. ...

36 CFR 13.970 - Frontcountry Developed Area definition.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Preserve Frontcountry Developed Area (fda) § 13.970 Frontcountry Developed Area definition. For purposes of this subpart, the Frontcountry Developed Area (FDA) means all park areas within the portion of the park... showing the FDA is available at the park visitor center. ...

36 CFR 13.970 - Frontcountry Developed Area definition.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Preserve Frontcountry Developed Area (fda) § 13.970 Frontcountry Developed Area definition. For purposes of this subpart, the Frontcountry Developed Area (FDA) means all park areas within the portion of the park... showing the FDA is available at the park visitor center. ...

Delegations of authority and organization; Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, and Center for Drug Evaluation and Research--FDA. Final rule.

PubMed

1991-11-21

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority relating to premarket approval of products that are or contain a biologic, a device, or a drug. The amendment grants directors, deputy directors, and certain other supervisory personnel in the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Center for Drug Evaluation and Research (CDER) reciprocal premarket approval authority to approve such products.

Medical Device Plug-and-Play Interoperability Standards and Technology Leadership

DTIC Science & Technology

2014-10-01

downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/ CDRH /CDRHReports/UCM391521.pdf. Dr. Goldman spoke in multiple panels at this workshop...downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTo bacco/ CDRH /CDRHReports/UCM391521.pdf  Arney D, Plourde J, Schrenker R, Mattegunta P

The use of the United States FDA programs as a strategy to advance the development of drug products for neglected tropical diseases.

PubMed

Sachs-Barrable, Kristina; Conway, Jocelyn; Gershkovich, Pavel; Ibrahim, Fady; Wasan, Kishor M

2014-11-01

Neglected tropical diseases (NTDs) are infections which are endemic in poor populations in lower- and middle-income countries (LMIC). Approximately one billion people have now or are at risk of getting an NTD and yet less than 5% of research dollars are focused on providing treatments and prevention of these highly debilitating and deadly conditions. The United States Food and Drug Administration (FDA) Orphan Drug Designation program (ODDP) provides orphan status to drugs and biologics, defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases and/or disorders that affect fewer than 200 000 people in the United States, or that affect more than 200 000 persons but are not expected to recover the costs of developing and marketing a treatment drug. These regulations have led to the translation of rare disease knowledge into innovative rare disease therapies. The FDA Guidance for Industry on developing drugs for the treatment and prevention of NTDs describes the following regulatory strategies: Orphan Product Designation, Fast Track Designation, Priority Review Designation, Accelerated Approval and Tropical Disease Priority Review Voucher. This paper will discuss how these regulations and especially the ODDP can improve the clinical development and accessibility of drug products for NTDs.

The Food and Drug Administration advisory committees and panels: how they are applied to the drug regulatory process.

PubMed

Ciociola, Arthur A; Karlstadt, Robyn G; Pambianco, Daniel J; Woods, Karen L; Ehrenpreis, Eli D

2014-10-01

Food and Drug Administration (FDA) advisory panels and committees play a critical role in advising the FDA on the safety and efficacy of medical devices and drugs marketed in the US. Advisory panel recommendations are used by the FDA to make decisions regarding medical products. Currently, the FDA utilizes over 50 advisory panels that serve the three major FDA centers, including the Centers for Biologics, Drugs and Device Products. Members of an advisory panel typically include academicians, clinicians, consumers, patients, and industry representatives. The FDA establishes the schedules for advisory panel meetings on an annual basis and a panel usually meets several times a year for two consecutive days in Washington, DC. Typically, the advisory panel discusses issues highlighted by the FDA and is then asked to vote a response to the questions posed in advance by the FDA. Advisory panel recommendations have a strong influence on FDA's decision to approve a product, as evidenced by the 214 Advisory Panels FDA convened between January 2008 to November 2012, during which advisory panel members voted to approve the product (or use of the product) ∼74% of the time, with FDA ultimately approving the medical product (or use of the product) ∼79% of the time. The ACG membership are encouraged to consider serving the public's interest by participating in an FDA advisory panel utilizing their expertise for the evaluation of a new drug or medical device, and providing advice about whether the product should be sold in the US.

76 FR 68770 - Product Shortage Report; Availability; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0690] Product Shortage Report; Availability; Request for Comments AGENCY: Food and Drug Administration, HHS..., particularly those products regulated by the FDA Center for Drug Evaluation and Research (CDER). FDA requests...

78 FR 54656 - Fee for Using a Priority Review Voucher in Fiscal Year 2014

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-05

... months, FDA estimates that a multiplier of 1.67 (10 months divided by 6 months) should be applied to non... checks to: U.S. Bank, Attention: Government Lockbox 979107, 1005 Convention Plaza, St. Louis, MO 63101...

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. 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/

75 FR 48699 - Memorandum of Understanding Between United States Food and Drug Administration and the Centers...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0004] [FDA 225-10-0010] Memorandum of Understanding Between United States Food and Drug Administration and the Centers for Medicare and Medicaid Services AGENCY: Food and Drug Administration, HHS. ACTION...

75 FR 54343 - Center for Biologics Evaluation and Research eSubmitter Pilot Evaluation Program for Blood...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0436... That Collect Whole Blood and Blood Components AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) is...

Combination products regulation at the FDA.

PubMed

Lauritsen, K J; Nguyen, T

2009-05-01

The US Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of drugs, biological products, and medical devices. As single-entity products, drugs are generally regulated by the Center for Drug Evaluation and Research (CDER), devices by the Center for Devices and Radiological Health (CDRH), and biologics by the Center for Biologics Evaluation and Research (CBER). In recent years, technological advances have led to a blurring of the historical lines of separation between the centers.

In Vitro Exposure Systems and Dosimetry Assessment Tools ...

EPA Pesticide Factsheets

In 2009, the passing of The Family Smoking Prevention and Tobacco Control Act facilitated the establishment of the FDA Center for Tobacco Products (CTP) and gave it regulatory authority over the marketing, manufacture and distribution of tobacco products, including those termed “modified risk”. On 4-6 April 2016, the Institute for In Vitro Sciences, Inc. (IIVS) convened a workshop conference titled “In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products” to bring together stakeholders representing regulatory agencies, academia, and industry to address the research priorities articulated by the FDA CTP. Specific topics were covered to assess the status of current in vitro smoke and aerosol/vapor exposure systems, as well as the various approaches and challenges to quantifying the complex exposures, in in vitro pulmonary models developed for evaluating adverse pulmonary events resulting from tobacco product exposures. The four core topics covered were, 1) Tobacco Smoke And E-Cigarette Aerosols, 2) Air-Liquid Interface-In Vitro Exposure Systems, 3) Dosimetry Approaches For Particles And Vapors; In Vitro Dosimetry Determinations and 4) Exposure Microenvironment/Physiology Of Cells. The two and a half day workshop included presentations from 20 expert speakers, poster sessions, networking discussions, and breakout sessions which identified key findings and provided recommendations to advance these technologies. Here, we will re

Evidentiary Support in Public Comments to the FDA's Center for Tobacco Products.

PubMed

Hemmerich, Natalie; Klein, Elizabeth G; Berman, Micah

2017-08-01

Electronic Nicotine Delivery Systems (ENDS) were introduced into the US market in 2007, and until recently these devices were unregulated at the federal level. In 2014, the US Food and Drug Administration (FDA) published a Notice of Proposed Rulemaking asserting its intention to regulate ENDS and requesting public comments on numerous related issues, including potential limits on the sale of flavored ENDS. This article analyzes key comments submitted to the FDA on the issue of flavor regulation in ENDS and examines the weight and credibility of the evidence presented by both supporters and opponents of regulation. It also describes the final deeming rule, published in May 2016, and the FDA's response to the evidence submitted. This is the first study to examine public comments submitted to the FDA's Center for Tobacco Products, and it concludes that opponents of regulation were more likely to rely on sources that were not peer reviewed and that were affected by conflicts of interest. In light of these findings, the FDA and the research community should develop processes to carefully and critically analyze public comments submitted to the FDA on issues of tobacco regulation. Copyright © 2017 by Duke University Press.

78 FR 8446 - Center for Drug Evaluation and Research; Prescription Drug Labeling Improvement and Enhancement...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-06

... products. \\5\\ Ibid. \\6\\ See http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 201, 314, and 601 [Docket No. FDA-2013-N-0059] Center for Drug Evaluation and Research; Prescription Drug Labeling...

76 FR 61103 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-03

... all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationand...),'' from CDRH you may either send an e-mail request to [email protected] to receive an electronic copy of... guidance describes how FDA's Center for Devices and Radiological Health (CDRH) and Center for Biologics...

77 FR 14402 - Draft Guidance on Classifying Significant Postmarket Drug Safety Issues; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-09

....'' This draft guidance describes FDA's current approach to classifying a significant postmarket drug... elevating some priority TSIs to an ``emergency'' status. The draft guidance was developed in connection with... guidance describes CDER's current approach to determining whether a significant postmarket drug safety...

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:

The Center for Devices and Radiological health: an update.

PubMed

Donawa, M

2001-12-01

At a recent medical device conference, Dr. David Feigal, the Director of the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) stated that one-third of the CDRH staff will retire in five years. This is only one of many challenges that the Center faces.This article discusses key factors shaping current FDA device policies and programmes, the CDRH strategic plan, the continuing importance of the standards programme, and CDRH harmonisation activities.

76 FR 45825 - Center for Devices and Radiological Health 510(k) Clearance Process; Institute of Medicine Report...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0556...: ``Medical Devices and the Public's Health, The FDA 510(k) Clearance Process at 35 Years;'' Request for... Drug Administration (FDA) is requesting comments on the Institute of Medicine (IOM) report entitled...

76 FR 54777 - Center for Devices and Radiological Health 510(k) Clearance Process; Recommendations Proposed in...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0556... Institute of Medicine Report: ``Medical Devices and the Public's Health, The FDA 510(k) Clearance Process at...; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a notice that appeared in the...

78 FR 63989 - Request for Notification From Industry Organizations Interested in Participating in the Selection...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-25

... the Center for Tobacco Products, notify FDA in writing. A nominee may either be self-nominated or... manufacturing industry must send a letter stating the interest to FDA by November 25, 2013, for the vacancy... FDA by November 25, 2013. ADDRESSES: All letters of interest and nominations should be submitted in...

76 FR 41804 - Town Hall Discussion With the Director of the Center for Devices and Radiological Health and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-15

... dialogue about issues of importance to FDA's Center for Devices and Radiological Health (CDRH) and to... call 650- 589-3400 and request the group rate for the ``FDA/CDRH Town Hall Meeting'' block of rooms... between 9 a.m. and 4 p.m., Monday through Friday. SUPPLEMENTARY INFORMATION: I. Background In 2010, CDRH...

Delegations of authority and organization; Center for Devices and Radiological Health--FDA. Final rule.

PubMed

1998-05-18

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority to reflect a new delegation that authorizes the Division Directors, Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) to approve, disapprove, or withdraw approval of product development protocols and applications for premarket approval for medical devices.

Enhancing the incorporation of the patient's voice in drug development and evaluation.

PubMed

Chalasani, Meghana; Vaidya, Pujita; Mullin, Theresa

2018-01-01

People living with a condition are uniquely positioned to inform the understanding of the therapeutic context for drug development and evaluation. In 2012, the U.S. Food and Drug Administration (FDA) established the Patient-Focused Drug Development (PFDD) initiative to more systematically obtain the patient perspective on specific diseases and their currently available treatments. PFDD meetings are unique among FDA public meetings, with a format designed to engage patients and elicit their perspectives on two topic areas: (1) the most significant symptoms of their condition and the impact of the condition on daily life; and, (2) their current approaches to treatment. FDA has conducted 24 disease-specific PFDD meetings to date. The lessons learned from PFDD meetings range from experiences common across rare diseases to more disease specific experiences that matter most to patients. FDA recognizes that FDA-led PFDD meetings alone cannot address the gaps in information on the patient perspective. Patient-focused drug development is an ongoing effort and FDA looks forward to the next steps in advancing the science and the utilization of patient input throughout drug development and evaluation. The U.S. Food and Drug Administration (FDA) has multiple mechanisms for its regulators and staff to interact with patients -- but none quite like its novel Patient-Focused Drug Development (PFDD) initiative. FDA established the PFDD initiative to more systematically obtain the patient perspective on specific diseases and their currently available treatments. Since the initiative's inception in 2012, FDA has held 24 PFDD meetings, covering a range of disease areas and hearing directly from thousands of patients and caregivers. FDA's PFDD meetings have also provided key stakeholders, including patient advocates, researchers, drug developers, healthcare providers, and other government officials, an opportunity to hear the patient's voice. The lessons learned include but are not limited to specific experiences that matter most to patients, patient perspectives on meaningful treatment benefits and how patients want to be engaged in the drug development process. FDA recognizes that FDA-led PFDD meetings alone cannot address the gaps in information on the patient perspective. Further enhancing the incorporation of the patient's voice in drug development and evaluation continues to be a priority for FDA.

Designating Additions to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act. Final order.

PubMed

2015-08-20

The Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizes the Food and Drug Administration (FDA or Agency) to award priority review vouchers (PRVs) to tropical disease product applicants when the applications meet certain criteria. The FD&C Act lists the diseases that are considered to be tropical diseases for purposes of obtaining PRVs, and also provides for Agency expansion of that list to include other diseases that satisfy the definition of ``tropical diseases'' as set forth in the FD&C Act. FDA has determined that Chagas disease and neurocysticercosis satisfy this definition, and therefore is adding them to the list of designated tropical diseases whose product applications may result in the award of PRVs. Sponsors submitting certain applications for the treatment of Chagas disease and neurocysticercosis may be eligible to receive a PRV if such applications are approved by FDA.

A Pressing Need for Pharmacotherapy Development to Treat Drug Addiction: An Editorial from a Legal Perspective.

PubMed

Andraka-Christou, B

2016-01-01

Only three FDA-approved pharmacological treatments exist for treating opiate dependence, all of which are underprescribed and underused. No FDA-approved pharmacological treatments exist for cocaine or methamphetamine dependence. More evidence-based, FDA-approved treatments are needed for treating drug dependence, but pharmaceutical companies are unlikely to pursue such research without government incentives. Today pharmaceutical companies primarily conduct research and development (R&D) related to "blockbuster" and rare diseases; drug dependence does not fall into either category. Further compounding the problem, pharmaceutical companies have been recently slashing risky areas of research, rather than adopting new areas. Fortunately, the government has a number of options to incentivize pharmaceutical R&D relating to drug dependence treatment, including the following: market exclusivity for new medications, tax breaks, priority review vouchers, liability reduction, and an advanced market commitment. © 2016 Elsevier Inc. All rights reserved.

Laboratory-based testing to evaluate abuse-deterrent formulations and satisfy the Food and Drug Administration's recommendation for Category 1 Testing.

PubMed

Altomare, Christopher; Kinzler, Eric R; Buchhalter, August R; Cone, Edward J; Costantino, Anthony

The US Food and Drug Administration (FDA) considers the development of abuse-deterrent formulations of solid oral dosage forms a public health priority and has outlined a series of premarket studies that should be performed prior to submitting an application to the Agency. Category 1 studies are performed to characterize whether the abuse-deterrent properties of a new formulation can be easily defeated. Study protocols are designed to evaluate common abuse patterns of prescription medications as well as more advanced methods that have been reported on drug abuse websites and forums. Because FDA believes Category 1 testing should fully characterize the abuse-deterrent characteristics of an investigational formulation, Category 1 testing is time consuming and requires specialized laboratory resources as well as advanced knowledge of prescription medication abuse. Recent Advisory Committee meetings at FDA have shown that Category 1 tests play a critical role in FDA's evaluation of an investigational formulation. In this article, we will provide a general overview of the methods of manipulation and routes of administration commonly utilized by prescription drug abusers, how those methods and routes are evaluated in a laboratory setting, and discuss data intake, analysis, and reporting to satisfy FDA's Category 1 testing requirements.

78 FR 37549 - Cooperative Agreement To Support the North Carolina State University, Prestage Department of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-21

... Unit located in Salisbury, NC. Egg-associated illness due to Salmonella is a major public health concern, with table eggs being the primary source of Salmonella Enteritidis. Therefore, an FDA priority is... Enteritidis and other Salmonella serovars to table eggs and poultry products. The goal of [[Page 37550

77 FR 30017 - International Capacity Building With Respect to Food Safety; Public Meeting; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-21

... the global supply chain as a key Agency priority. Indeed, two recent reports have focused on the challenges of global supply chains: FDA's ``Pathway to Global Product Safety and Quality,'' and the Institute... more authorities to address the increasingly globalized food supply and prevent problems before they...

Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications.

PubMed

DiMasi, Joseph A

2013-06-01

Much of the literature on trends and factors affecting biopharmaceutical innovation has focused overwhelmingly on the development and approval of never-before approved drugs and biologics. Little attention has been paid to new uses for already-approved compounds, which can be an important form of innovation. This paper aimed to determine and analyze recent trends in the number and type of new or modified US indication approvals for drugs and biologics. We also examine regulatory approval-phase times for new-use efficacy supplements and compare them to approval-phase times for original-use approvals over the same period. We developed a data set of efficacy supplements approved by the US Food and Drug Administration (FDA) from 1998 to 2011 that includes information on the type, approval-phase time (time from submission to the FDA of an application for marketing approval to approval of the application), and FDA therapeutic-significance rating for the approved application, which we obtained from an FDA Web site. This data set was merged with a Tufts Center for the Study of Drug Development (CSDD) data set of US new drug and biologics approvals. We developed descriptive statistics on trends in the number and type of new-use efficacy supplements, on US regulatory approval-phase times for the supplements, and on original new drug and biologics approvals over the study period and for the time from original- to new-use approval. The total number of new-use efficacy-supplement approvals did not exhibit a marked trend, but the number of new pediatric-indication approvals increased substantially. Approval-phase times for new-use supplements varied by therapeutic class and FDA therapeutic-significance rating. Mean approval-phase times were highest for central nervous system compounds (13.8 months) and lowest for antineoplastics (8.9 months). The mean time from original to supplement approval was substantially longer for new pediatric indications than for other new uses. Mean approval-phase time during the study period for applications that received a standard review rating from the FDA was substantially shorter for supplements compared to original uses, but the differences for applications that received a priority review rating from the FDA were negligible. Development of and regulatory approval for new uses of already-approved drugs and biologics is an important source of innovation by biopharmaceutical firms. Despite rising development costs, the output of new-use approvals has remained stable in recent years, driven largely by the pursuit of new pediatric indications. FDA approval-phase times have generally declined substantially for all types of applications since the mid-1990s following legislation that provided a new source of income for the agency. However, while the resources needed to review supplemental applications are likely lower in general than for original-use approvals, the approval-phase times for important new uses are no lower than for important original-use applications. Copyright © 2013 Elsevier HS Journals, Inc. All rights reserved.

Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study.

PubMed

Kesselheim, Aaron S; Wang, Bo; Franklin, Jessica M; Darrow, Jonathan J

2015-09-23

To evaluate the use of special expedited development and review pathways at the US Food and Drug Administration over the past two decades. Cohort study. FDA approved novel therapeutics between 1987 and 2014. Publicly available sources provided each drug's year of approval, their innovativeness (first in class versus not first in class), World Health Organization Anatomic Therapeutic Classification, and which (if any) of the FDA's four primary expedited development and review programs or designations were associated with each drug: orphan drug, fast track, accelerated approval, and priority review. Logistic regression models evaluated trends in the proportion of drugs associated with each of the four expedited development and review programs. To evaluate the number of programs associated with each approved drug over time, Poisson models were employed, with the number of programs as the dependent variable and a linear term for year of approval. The difference in trends was compared between drugs that were first in class and those that were not. The FDA approved 774 drugs during the study period, with one third representing first in class agents. Priority review (43%) was the most prevalent of the four programs, with accelerated approval (9%) the least common. There was a significant increase of 2.6% per year in the number of expedited review and approval programs granted to each newly approved agent (incidence rate ratio 1.026, 95% confidence interval 1.017 to 1.035, P<0.001), and a 2.4% increase in the proportion of drugs associated with at least one such program (odds ratio 1.024, 95% confidence interval 1.006 to 1.043, P=0.009). Driving this trend was an increase in the proportion of approved, non-first in class drugs associated with at least one program for drugs (P=0.03 for interaction). In the past two decades, drugs newly approved by the FDA have been associated with an increasing number of expedited development or review programs. Though expedited programs should be strictly limited to drugs providing noticeable clinical advances, this trend is being driven by drugs that are not first in class and thus potentially less innovative. © Kesselheim et al 2015.

21 CFR 822.15 - How long must I conduct postmarket surveillance of my device?

Code of Federal Regulations, 2013 CFR

2013-04-01

... Radiological Health's (CDRH') Web site (http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOmbudsman/default.htm.). The 36-month period refers to the surveillance period, not the...

21 CFR 822.15 - How long must I conduct postmarket surveillance of my device?

Code of Federal Regulations, 2014 CFR

2014-04-01

... Radiological Health's (CDRH') Web site (http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOmbudsman/default.htm.). The 36-month period refers to the surveillance period, not the...

The Tropical Disease Priority Review Voucher: A Game-Changer for Tropical Disease Products

PubMed Central

Berman, Jonathan; Radhakrishna, Tanya

2017-01-01

The Neglected Tropical Disease Voucher Program is a Congressionally-mandated program intended to promote approval of products for tropical diseases because it provides spectacular financial compensation consequent to FDA approval of a priority product. Three drug approvals–artemether/lumifantrine for malaria, bedaquiline for multidrug resistant tuberculosis, miltefosine for leishmaniasis–have received Tropical Disease Vouchers to date. We give our view of the type of products that might qualify for a Tropical Disease Voucher, financial considerations in venturing capital to support product development, clinical ramifications of a successful product approval, and an overall evaluation of the Program. PMID:27573627

Hydrogen peroxide as a fungicide for fish culture

USGS Publications Warehouse

Dawson, V.K.; Rach, J.J.; Schreier, Theresa M.

1994-01-01

Antifungal agents are needed to maintain healthy stocks of fish in the intensive culture systems currently employed in fish hatcheries. Malachite green has been the most widely used antifungal agent; however, its potential for producing teratology in animals and fish precludes further use in fish culture. Preliminary studies at the National Fisheries Research Center, La Crosse, WI, USA (La Crosse Center) indicate that hydrogen peroxide is effective for control of Saprolegnia sp. fungus on incubating eggs of rainbow trout. It is also effective against a wide variety of other organisms such as bacteria, yeasts, viruses, and spores, and has been proposed as a treatment for sea lice on salmon. Hydrogen peroxide and its primary decomposition products, oxygen and water, are not systemic poisons and are considered environmentally compatible. In response to a petition from the La Crosse Center, the U.S. Food and Drug Administration (FDA) recently classified hydrogen peroxide as a 'low regulatory priority' when used for control of fungus on fish and fish eggs. Preliminary tests conducted at the La Crosse Center suggest that prophylactic treatments of 250 to 500 ppm (based on 100% active ingredient) for 15 minutes every other day will inhibit fungal infections on healthy rainbow trout (Oncorhynchus mykiss) eggs. This treatment regime also seems to inhibit fungal development and increase hatching success among infected eggs. Efficacy and safety of hydrogen peroxide as a fungicide for fish are currently being evaluated.

Final priorities; National Institute on Disability and Rehabilitation Research--Disability and Rehabilitation Research Projects and Centers Program--Rehabilitation Engineering Research Centers. Final priorities.

PubMed

2013-06-11

The Assistant Secretary for Special Education and Rehabilitative Services announces priorities under the Disability and Rehabilitation Research Projects and Centers Program administered by the National Institute on Disability and Rehabilitation Research (NIDRR). Specifically, we announce priorities for a Rehabilitation Engineering Research Center (RERC) on Rehabilitation Strategies, Techniques, and Interventions (Priority 1), Information and Communication Technologies Access (Priority 2), Individual Mobility and Manipulation (Priority 3), and Physical Access and Transportation (Priority 4). The Assistant Secretary may use one or more of these priorities for competitions in fiscal year (FY) 2013 and later years. We take this action to focus research attention on areas of national need. We intend these priorities to improve community living and participation, health and function, and employment outcomes of individuals with disabilities.

77 FR 60440 - Clinical Investigator Training Course

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-03

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Clinical Investigator Training Course AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research/Office of Medical...

Regulating biopharmaceuticals under CDER versus CBER: an insider's perspective.

PubMed

Schwieterman, William D

2006-10-01

The FDA has recently transferred jurisdiction for the regulation of certain biopharmaceuticals from the Center for Biologics, Evaluation and Research to the Center for Drugs, Evaluation and Research, where they will be reviewed in the same FDA divisions as are traditional pharmaceutical agents. With this transfer, sponsors of investigational biopharmaceuticals should expect changes in the regulatory requirements the FDA imposes on the clinical development plans, including an increase in the size and number of pivotal studies; more consistent requirements for conducting preclinical tests in two animal species; increased emphasis on organ structure and function as components of primary endpoints; more emphasis on characterizing dose-ranging and pharmacology; more intense scrutinizing of product advertising; and decreased direct communication with the review team.

International Conference on Harmonisation; Electronic Transmission of Postmarket Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines; Availability of Food and Drug Administration Regional Implementation Specifications for ICH E2B(R3) Reporting to the Food and Drug Administration Adverse Event Reporting System. Notice of Availability.

PubMed

2016-06-23

The Food and Drug Administration (FDA) is announcing the availability of its FDA Adverse Event Reporting System (FAERS) Regional Implementation Specifications for the International Conference on Harmonisation (ICH) E2B(R3) Specification. FDA is making this technical specifications document available to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This document, entitled "FDA Regional Implementation Specifications for ICH E2B(R3) Implementation: Postmarket Submission of Individual Case Safety Reports (ICSRs) for Drugs and Biologics, Excluding Vaccines" supplements the "E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide--Data Elements and Message Specification" final guidance for industry and describes FDA's technical approach for receiving ICSRs, for incorporating regionally controlled terminology, and for adding region-specific data elements when reporting to FAERS.

76 FR 4919 - Regulatory Site Visit Training Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0046] Regulatory Site Visit Training Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is...

75 FR 6404 - Regulatory Site Visit Training Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0045] (formerly Docket No. 2004N-0408) Regulatory Site Visit Training Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration's (FDA's) Center for Biologics...

21 CFR 822.7 - What should I do if I do not agree that postmarket surveillance is appropriate?

Code of Federal Regulations, 2013 CFR

2013-04-01

... Radiological Health's (CDRH's) Web site (http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOmbudsman/default.htm.). [67 FR 38887, June 6, 2002, as amended at 72 FR 17399, Apr. 9...

77 FR 73035 - Request for Notification From Industry Organizations Interested in Participating in the Selection...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-07

... Committee (MDAC) in the Center for Devices and Radiological Health (CDRH) notify FDA in writing. FDA is also... in the CDRH. A nominee may either be self-nominated or nominated by an organization to serve as a...

21 CFR 822.7 - What should I do if I do not agree that postmarket surveillance is appropriate?

Code of Federal Regulations, 2014 CFR

2014-04-01

... Radiological Health's (CDRH's) Web site (http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOmbudsman/default.htm.). [67 FR 38887, June 6, 2002, as amended at 72 FR 17399, Apr. 9...

Proceedings of the Food and Drug Administration's public workshop on new red blood cell product regulatory science 2016.

PubMed

Vostal, Jaroslav G; Buehler, Paul W; Gelderman, Monique P; Alayash, Abdu I; Doctor, Alan; Zimring, James C; Glynn, Simone A; Hess, John R; Klein, Harvey; Acker, Jason P; Spinella, Philip C; D'Alessandro, Angelo; Palsson, Bernhard; Raife, Thomas J; Busch, Michael P; McMahon, Timothy J; Intaglietta, Marcos; Swartz, Harold M; Dubick, Michael A; Cardin, Sylvain; Patel, Rakesh P; Natanson, Charles; Weisel, John W; Muszynski, Jennifer A; Norris, Philip J; Ness, Paul M

2018-01-01

The US Food and Drug Administration (FDA) held a workshop on red blood cell (RBC) product regulatory science on October 6 and 7, 2016, at the Natcher Conference Center on the National Institutes of Health (NIH) Campus in Bethesda, Maryland. The workshop was supported by the National Heart, Lung, and Blood Institute, NIH; the Department of Defense; the Office of the Assistant Secretary for Health, Department of Health and Human Services; and the Center for Biologics Evaluation and Research, FDA. The workshop reviewed the status and scientific basis of the current regulatory framework and the available scientific tools to expand it to evaluate innovative and future RBC transfusion products. A full record of the proceedings is available on the FDA website (http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm507890.htm). The contents of the summary are the authors' opinions and do not represent agency policy. © 2017 AABB.

A roundtable discussion: home healthcare-not a hospital in the home.

PubMed

Logan, Mary K; Parker, Chuck; Gardner-Bonneau, Daryle; Treu, Denny; Keller, James; Winstel, Lisa; Weick-Brady, Mary; Kramer, Nancy; Cyrus, Reginald; Thiel, Scott; Lewis, Vicki R; Rogers, Wendy

2013-01-01

Home healthcare is vital for a large percentage of the population. According to data from the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control (CDC), 7 million people in the United States receive home healthcare annually. The use of medical devices in the home and other nonclinical environments is increasing dramatically. By the year 2050, an estimated 27 million people will need continuing care in the home or in the community and not in a controlled clinical environment. 1 The FDA recently announced its Home Use Devices Initiative and issued the document, "Draft Guidance for Industry and FDA Staff-Design Considerations for Devices Intended for Home Use" on Dec. 12, 2012. 2 The Center for Devices and Radiological Health (CDRH) regulates medical devices, but that regulatory authority alone is not enough to ensure safe and effective use of devices in the home. To address these and other issues, AAMI and FDA will co-host a summit on healthcare technology in nonclinical settings Oct. 9-10, 2013.

Exceptions or alternatives to labeling requirements for products held by the Strategic National Stockpile. Final rule.

PubMed

2012-02-06

The Food and Drug Administration (FDA) is adopting as a final rule, without change, the interim final rule that issued regulations permitting FDA Center Directors to grant exceptions or alternatives to certain regulatory labeling requirements applicable to human drugs, biological products, or medical devices that are or will be included in the Strategic National Stockpile (SNS). FDA is taking this action to complete the rulemaking initiated with the interim final rule.

Medtronic, Inc.; premarket approval of the Interstim Sacral Nerve Stimulation (SNS) System--FDA. Notice.

PubMed

1998-01-29

The Food and Drug Administration (FDA) is announcing its approval of the application by Medtronic, Inc., Minneapolis, MN, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Interstim Sacral Nerve Stimulation (SNS) System. After reviewing the recommendation of the Gastroenterology and Urology Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of September 29, 1997, of the approval of the application.

How to Submit | Center for Cancer Research

Cancer.gov

be submitted by a current NIH or FDA fellow. The work does not need to have been done at the NIH/FDA. However, the submitter must be an author on the document and be in compliance with the intended journal's authorship guidelines or general good authorship practices. 

The Tropical Disease Priority Review Voucher: A Game-Changer for Tropical Disease Products.

PubMed

Berman, Jonathan; Radhakrishna, Tanya

2017-01-11

The Neglected Tropical Disease Voucher Program is a Congressionally-mandated program intended to promote approval of products for tropical diseases because it provides spectacular financial compensation consequent to FDA approval of a priority product. Three drug approvals-artemether/lumifantrine for malaria, bedaquiline for multidrug resistant tuberculosis, miltefosine for leishmaniasis-have received Tropical Disease Vouchers to date. We give our view of the type of products that might qualify for a Tropical Disease Voucher, financial considerations in venturing capital to support product development, clinical ramifications of a successful product approval, and an overall evaluation of the Program. © The American Society of Tropical Medicine and Hygiene.

76 FR 53910 - Fee for Using a Priority Review Voucher in Fiscal Year 2012

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-30

... ordinarily takes 10 months into 6 months, OPP estimates that a multiplier of 1.67 (10 months divided by 6... FY 2010. Dividing $6,856,000 (rounded to the nearest thousand dollars) by 13 (the total number of... adjust the FY 2010 cost figure above by the average amount by which FDA's average salary and benefit...

77 FR 56649 - Fee for Using a Priority Review Voucher in Fiscal Year 2013

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-13

... months, OPP estimates that a multiplier of 1.67 (10 months divided by 6 months) should be applied to non... which FDA's average salary and benefit costs increased in the 3 years prior to FY 2012, to adjust the FY... that requests a street address, the courier can deliver the checks to: U.S. Bank, Attention: Government...

New technology in electrophysiology: FDA process and perspective.

PubMed

Selzman, Kimberly A; Fellman, Mark; Farb, Andrew; de Del Castillo, Sergio; Zuckerman, Bram

2016-10-01

The Food and Drug Administration (FDA) is a large regulatory agency that monitors everything from food, tobacco, and veterinary medicine to pharmaceutical drugs and medical devices. The Mission statement of the CDRH, one of the Centers of the FDA, in its most succinct form is to protect and promote public health. This is accomplished through timely and continued access to safe, effective, and high quality medical devices. This paper aims to review the overarching principles of the Agency's review process for cardiac devices as well as highlight some of the newer programs that FDA has engaged in to facilitate innovation, device development, research, and timely market approval.

76 FR 63305 - Approaches To Reducing Sodium Consumption; Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-12

... Service (FSIS), the Agricultural Research Service (ARS) and the Center for Nutrition Policy and Promotion... future Agency activities regarding the reduction of dietary intake of sodium. FDA, CDC, FSIS, ARS, and..._Sodium_Reduction by November 3, 2011. FDA, CDC, FSIS, ARS, and CNPP are holding the public meeting on...

76 FR 11490 - Withdrawal of Approval of New Animal Drug Applications; Phenylbutazone; Pyrantel; Tylosin...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0033... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... INFORMATION CONTACT: John Bartkowiak, Center for Veterinary Medicine (HFV-212), Food and Drug Administration...

75 FR 10806 - Training Program for Regulatory Project Managers; Information Available to Industry

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0108] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) Center for Drug Evaluation...

78 FR 8544 - Training Program for Regulatory Project Managers; Information Available to Industry

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2003-N-0453] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration's (FDA's) Center for Drug...

78 FR 20663 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-05

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function..., Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. FDA intends to...

Recommendations to minimize diagnostic nuclear medicine exposure to the embryo, fetus, and infant; availability of final recommendations--FDA. Notice.

PubMed

1986-02-19

Food and Drug Administration (FDA) is announcing the availability of final recommendations to minimize diagnostic nuclear medicine exposure to the embryo, fetus, and breastfeeding infant. The final recommendations, prepared by FDA's Center for Devices and Radiological Health (CDRH), include the agency's rationale for the recommendations as well as the endorsement of the recommendations by several professional organizations. The final recommendations are being published in a pamphlet that is being made available to interested persons.

Medical countermeasures for unwanted CBRN exposures: part II radiological and nuclear threats with review of recent countermeasure patents

PubMed Central

Singh, Vijay K.; Romaine, Patricia L.P.; Newman, Victoria L.; Seed, Thomas M.

2016-01-01

ABSTRACT Introduction: The global threat of a chemical, biological, radiological, or nuclear (CBRN) disaster is an important priority for all government agencies involved in domestic security and public health preparedness. Radiological/nuclear (RN) attacks or accidents have become a larger focus of the United States Food and Drug administration (US FDA) over time because of their increased likeliness. Clinical signs and symptoms of a developing acute radiation syndrome (ARS) are grouped into three sub-syndromes named for the dominant organ system affected, namely the hematopoietic (H-ARS), gastrointestinal (GI-ARS), and neurovascular systems. The availability of safe and effective countermeasures against radiological/nuclear threats currently represents a significant unmet medical need. Areas covered: This article reviews the development of RN threat medical countermeasures and highlights those specific countermeasures that have been recently patented and approved following the FDA Animal Rule. Patents for such agents from 2015 have been presented. Expert opinion: Two granulocyte colony-stimulating factor (G-CSF)-based radiation countermeasures (Neupogen® (Amgen, Thousand Oaks, CA) and Neulasta® (Amgen, Thousand Oaks, CA)) have recently been approved by the FDA for treatment of H-ARS and both these agents are radiomitigators, used after radiation exposure. To date, there are no FDA-approved radioprotectors for ARS. PMID:27610458

Food and Drug Administration workshop on indirect mechanisms of carcinogenesis.

PubMed

Poirier, L A

1996-01-01

A workshop sponsored by the Food and Drug Administration (FDA) was held on March 4-5, 1996, at the Lister Hill Auditorium of the National Institutes of Health (NIH) Campus in Bethesda, Maryland. The workshop considered both the scientific aspects and the regulatory implications of indirect-acting carcinogens. A wide variety of agents and of prospective mechanisms was discussed. The organizing committee for the workshop consisted of Drs. James Farrelly and Joseph DeGeorge of the Center for Drug Evaluation and Research (CDER), Ronald J. Lorentzen and Sidney Green of the Center for Food Safety and Applied Nutrition (CFSAN), Martin D. Green of the Center for Biologics, Evaluation and Research (CBER), C. Darnell Jackson and Lionel A. Poirier of the National Center for Toxicological Research (NCTR). Rosalie K. Elespuru of the Center for Devices and Radiological Health (CDRH), and David G. Longfellow of the National Cancer Institute (NCI). Following an introduction by Dr. Poirier, who provided a description of indirect carcinogens, the major talks were grouped into three formal sessions: indirect-acting compounds and agents of FDA interest, biological and biochemical endpoints commonly seen with indirect agents, and specific problems associated with the indirect-acting compounds. A panel discussion followed and the concluding remarks were made by Dr. Bernard A. Schwetz, Associate Commissioner for Science, FDA.

Advancing regulatory science to bring novel medical devices for use in emergency care to market: the role of the Food and Drug Administration.

PubMed

Scully, Christopher G; Forrest, Shawn; Galeotti, Loriano; Schwartz, Suzanne B; Strauss, David G

2015-04-01

The Food and Drug Administration (FDA) performs regulatory science to provide science-based medical product regulatory decisions. This article describes the types of scientific research the FDA's Center for Devices and Radiological Health performs and highlights specific projects related to medical devices for emergency medicine. In addition, this article discusses how results from regulatory science are used by the FDA to support the regulatory process as well as how the results are communicated to the public. Regulatory science supports the FDA's mission to assure safe, effective, and high-quality medical products are available to patients. Published by Elsevier Inc.

78 FR 50422 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-19

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2013-M-0462... Wolanski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave..... ABI 7500 Fast DX Real-Time PCR Instrument. P060028, FDA-2013-M-0738..... Mentor Worldwide LLC...

21 CFR 118.8 - Testing methodology for Salmonella Enteritidis (SE).

Code of Federal Regulations, 2010 CFR

2010-04-01

... Salmonella Web site is located at http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/ucm114716.htm... you may examine a copy at the Center for Food Safety and Applied Nutrition's Library, 5100 Paint... Edition, is located at http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalytical...

78 FR 43889 - Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-22

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA), Center for...

75 FR 386 - Memorandum of Understanding Between the United States Department of Health and Human Services...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0667... Services, Food and Drug Administration, Center for Drug Evaluation and Research and Northeastern University AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA...

78 FR 79699 - Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-31

... Harvey, Food and Drug Administration, Center for Biologics Evaluation and Research, 1401 Rockville Pike... Biologics Evaluation and Research (CBER), FDA. On February 26, 2014, from 1 p.m. to approximately 5 p.m... and gene therapy products. CBER published guidance on this topic in July 2013 ( http://www.fda.gov...

76 FR 66309 - Pilot Program for Parallel Review of Medical Products; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-26

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services [CMS-3180-N2] Food and Drug Administration [Docket No. FDA-2010-N-0308] Pilot Program for Parallel Review of Medical... technologies to participate in a program of parallel FDA-CMS review. The document was published with an...

76 FR 24495 - Reprocessing of Reusable Medical Devices; Public Workshop

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-02

... workshop will be held in the Great Room at the FDA White Oak Conference Center, Bldg. 31, Rm. 1503, 10903... requests to make oral presentations, as well as presentation materials, must be sent to the contact person... sterilization process, potentially resulting in HAIs or other adverse patient outcomes. FDA receives reports of...

75 FR 65495 - Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-25

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0529...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... framework for interactions between the Center for Drug Evaluation and Research (CDER) and DDT sponsors to...

78 FR 24754 - Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-26

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0800... and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and...

78 FR 15956 - Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0595... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug...

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, improve analysis tools that will better identify device safety trends, and improve the ability to prevent or mitigate effects of adverse events associated with medical device use.

Final priority; National Institute on Disability and Rehabilitation Research--Disability and Rehabilitation Projects and Centers Program--Rehabilitation Engineering Research Centers. Final priority.

PubMed

2013-06-19

The Assistant Secretary for Special Education and Rehabilitative Services announces a priority for a Rehabilitation Engineering Research Center (RERC) on Technologies to Support Successful Aging with Disability under the Disability and Rehabilitation Research Projects and Centers Program administered by the National Institute on Disability and Rehabilitation Research (NIDRR). The Assistant Secretary may use this priority for a competition in fiscal year (FY) 2013 and later years. We take this action to focus research attention on areas of national need. We intend to use this priority to improve outcomes for individuals with disabilities.

Final priority; National Institute on Disability and Rehabilitation Research--Disability and Rehabilitation Research Projects and Centers Program--Rehabilitation Engineering Research Centers. Final priority.

PubMed

2013-06-14

The Assistant Secretary for Special Education and Rehabilitative Services announces a priority for a Rehabilitation Engineering Research Center (RERC) on Universal Interfaces and Information Technology Access under the Disability and Rehabilitation Research Projects and Centers Program administered by the National Institute on Disability and Rehabilitation Research (NIDRR). The Assistant Secretary may use this priority for a competition in fiscal year (FY) 2013 and later years. We take this action to focus research attention on areas of national need. We intend to use this priority to improve outcomes for individuals with disabilities.

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

2016 in review: FDA approvals of new molecular entities.

PubMed

Griesenauer, Rebekah H; Kinch, Michael S

2017-11-01

An overview of drugs approved by FDA in 2016 reveals dramatic disruptions in long-term trends. The number of new molecular entities (NMEs) dropped, reflecting the lowest rate of small-molecule approvals observed in almost five decades. In addition, the pace of industry consolidation slowed substantially. The impact of mergers and acquisitions decreased the total number of organizations with past approval experience and continued research and development (R&D) activities to 102, divided evenly between more established pharmaceutical and newer biotechnology companies. Despite these substantial differences, the industry continued to pursue regulatory incentives, as evidenced by a continued increase in the fraction of NMEs approved using an orphan or priority designation, and almost all oncology drugs approved in 2016 utilized these mechanisms. Copyright © 2017 Elsevier Ltd. All rights reserved.

Valbenazine for the treatment of tardive dyskinesia.

PubMed

Barquero, N

2016-12-01

Valbenazine (NBI-98854, Ingrezza) is a highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor that modulates dopamine release during nerve communication. The pharmacological target VMAT2 may play an important role in the treatment of tardive dyskinesia (TD), an iatrogenic condition associated with the administration of antipsychotic medication for long periods and characterized by rapid, repetitive, stereotypic, involuntary movements of the face and extremities. There are currently no Food and Drug Administration (FDA)-approved drugs for the treatment of TD. Results of clinical trials have shown a distinctive improvement in TD symptoms during valbenazine administration and a new drug application submitted to the FDA in August 2016 is undergoing priority review with a decision expected in April 2017. Copyright 2016 Prous Science, S.A.U. or its licensors. All rights reserved.

Guidance for the emergency use of unapproved medical devices; availability--FDA. Notice.

PubMed

1985-10-22

The Food and Drug Administration (FDA) is announcing guidance, developed by FDA's Center for Devices and Radiological Health (CDRH), with respect to those emergency situations in which the agency would not object to a physician's using a potentially life-saving medical device for a use for which the device ordinarily is required to have, but does not have, an approved application for premarket approval or an investigational device exemption. The guidance is contained in a document entitled "guidance for the Emergency Use of Unapproved Medical Devices."

76 FR 38134 - Final Priorities; Disability and Rehabilitation Research Projects and Centers Program-Disability...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-29

...-identified research designs to generate reliable and valid findings. Changes: None. Final Priorities Priority... DEPARTMENT OF EDUCATION Final Priorities; Disability and Rehabilitation Research Projects and Centers Program--Disability Rehabilitation Research Projects, etc. AGENCY: Office of Special Education and...

75 FR 4402 - Strengthening the Center for Devices and Radiological Health's 510(k) Review Process; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-27

..., clinical studies conducted to demonstrate superiority to a control, instead of non- inferiority to a... will include no more than 10 non-FDA participants. Only one participant from an organization or company will be assigned to the discussion group. FDA will attempt to have a range of constituencies...

Piloting the future: Results from a pilot study for changes in the animal sampling program for the national antibiotic resistance monitoring system (NARMS)

USDA-ARS?s Scientific Manuscript database

A well recognized monitoring system for antimicrobial resistance in the U. S. is the National Antimicrobial Resistance Monitoring System (NARMS). It was established in 1996 among the Food and Drug Administration (FDA), USDA, and Centers for Disease Control and Prevention (CDC). FDA coordinates the ...

78 FR 44133 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-23

... Dapolito or Rosanna Harvey, Food and Drug Administration, Center for Biologics Evaluation and Research... Research (CBER), FDA. On October 23, 2013, from 12:30 p.m. to approximately 5 p.m. the Committee will.... CBER is planning to publish guidance on this topic during calendar year 2013. FDA intends to make...

76 FR 3912 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002... advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name... is 214- 651-1234. Contact Person: Yvette Waples, Center for Drug Evaluation and Research, Food and...

Human factors and the FDA's goals: improved medical device design.

PubMed

Burlington, D B

1996-01-01

The Food and Drug Administration's new human factors design requirements for medical devices were previewed by the director of the FDA's Center for Devices and Radiological Health (CDRH) at AAMI/FDA's Human Factors in Medical Devices Conference held in September 1995. Director Bruce Burlington, MD, said the FDA plans to take a closer look at how new medical devices are designed to ensure proper attention has been paid to human error prevention. As a medical practitioner who has witnessed use-related deaths and injuries, Burlington stressed the importance of the medical community's reporting use errors as they occur and manufacturers' creating easy-to-use labeling and packaging. He also called for simplicity and quality of design in medical products, and asked for a consolidated effort of all professionals involved in human factors issues to help implement and further the FDA's new human factors program. An edited version of his presentation appears here.

Retrospective review of the performance standard for diagnostic x-ray equipment; availability of report--FDA. Notice; final rule-related.

PubMed

1985-11-12

The Food and Drug Administration (FDA) is announcing the availability of a report prepared by the X-Ray Standard Review Group (XSRG) in FDA's Center for Devices and Radiological Health (CDRH). The report contains the review group's assessment of the performance standard for diagnostic x-ray systems and their major components. It contains recommendations for changes in the standard with respect to the need to ensure that regulatory controls keep pace with developing technology and the needs of the radiological community. In addition, FDA is inviting interested persons to submit written comments, data, or information regarding the report for the agency's consideration in deciding whether to initiate any changes in the performance standard.

Battlefield Trauma Care Research, Development, Test and Evaluation Priorities

DTIC Science & Technology

2011-06-14

approved them by unanimous vote on March 8, 2011. FINDINGS Non-Compressible Hemorrhage Control-Follow-Up Tranexamic Acid Studies 5. Hemorrhagic shock...received tranexamic acid demonstrated a significant decrease in mortality without any increase in venous occlusive events either accompanied by or at...occlusive events. 8. Tranexarnic acid is a low-cost, FDA-approved agent. 9. The potential benefit and optimal use of tranexamic acid are not yet

Phase 2 Clinical Trial of AC105 (Mg/PEG) for Treatment of Acute Spinal Cord Injury (SCI)

DTIC Science & Technology

2015-12-01

initiation of 10 centers in the first 6 months, and an additional 10 centers over the next 6 months, the subject recruitment phase would have...Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 Q10 Q11 Q12 FDA Approval, Planning & Rolling Initiation of Sites Active phase of study: 6 & 12 month follow-ups Data...analysis Reports The Proposed Milestones for the project were: 1. Month 3 – FDA approval of clinical protocol 2. Month 6 – First site initiation and IRB

Preapproval and postapproval availability of published comparative efficacy research on biological agents.

PubMed

Thomas, Rachel Hutchins; Freeman, Maisha Kelly; Hughes, Peter J

2013-07-15

Preapproval and postapproval availability of published comparative efficacy studies on biological agents approved between 2000 and 2010 was investigated. Approval packages published on the Food and Drug Administration (FDA) website were examined for all biological agents approved between 2000 and 2010 to determine if comparative efficacy studies were available at the time of FDA approval. The availability of comparative efficacy studies published subsequent to approval was determined by searching PubMed for randomized, active-controlled experimental or observational study designs that measured efficacy as the primary endpoint and were relevant to the original FDA-approved indication. From 2000 to 2010, 107 biological agents were approved by FDA. Of the biological agents with alternative treatments, 54.6% had comparative efficacy data available at the time of approval. Although standard-reviewed biological agents were more likely to have comparative efficacy trials included in the FDA approval packages than priority-reviewed biological agents, statistically significant differences are unlikely. Subsequent to approval, 58.1% of biological agents had at least one published comparative efficacy trial, representing a 3.5% absolute increase in the availability of comparative efficacy studies since the time of approval. Vaccines and biological agents in the hematologic diseases, oncology, and miscellaneous diseases classes had fewer published postapproval comparative efficacy studies per agent compared with the overall group of biological agents. Nearly half of all biological agents approved for marketing between 2000 and 2010 lacked publicly accessible, active-controlled efficacy studies at the time of drug approval; a slightly greater proportion of biological agents had comparative efficacy data published subsequent to their approval.

78 FR 66742 - Determination That MOBAN (Molindone Hydrochloride) Tablets (5 Milligrams, 10 Milligrams, 25...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-06

... regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Emily Helms Williams, Center for Drug... now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ``Approved...

FDA Approval: Ibrutinib for Patients with Previously Treated Mantle Cell Lymphoma and Previously Treated Chronic Lymphocytic Leukemia.

PubMed

de Claro, R Angelo; McGinn, Karen M; Verdun, Nicole; Lee, Shwu-Luan; Chiu, Haw-Jyh; Saber, Haleh; Brower, Margaret E; Chang, C J George; Pfuma, Elimika; Habtemariam, Bahru; Bullock, Julie; Wang, Yun; Nie, Lei; Chen, Xiao-Hong; Lu, Donghao Robert; Al-Hakim, Ali; Kane, Robert C; Kaminskas, Edvardas; Justice, Robert; Farrell, Ann T; Pazdur, Richard

2015-08-15

On November 13, 2013, the FDA granted accelerated approval to ibrutinib (IMBRUVICA capsules; Pharmacyclics, Inc.) for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. On February 12, 2014, the FDA granted accelerated approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Ibrutinib is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor that received all four expedited programs of the FDA: Fast-Track designation, Breakthrough Therapy designation, Priority Review, and Accelerated Approval. Both approvals were based on overall response rate (ORR) and duration of response (DOR) in single-arm clinical trials in patients with prior treatment. In MCL (N = 111), the complete and partial response rates were 17.1% and 48.6%, respectively, for an ORR of 65.8% [95% confidence interval (CI), 56.2%-74.5%]. The median DOR was 17.5 months (95% CI, 15.8-not reached). In CLL (N = 48), the ORR was 58.3% (95% CI, 43.2%-72.4%), and the DOR ranged from 5.6 to 24.2 months. The most common adverse reactions (≥ 30% in either trial) were thrombocytopenia, diarrhea, neutropenia, bruising, upper respiratory tract infection, anemia, fatigue, musculoskeletal pain, peripheral edema, and nausea. ©2015 American Association for Cancer Research.

Blueprint for prescriber continuing education program.

PubMed

2012-06-01

On October 25, 2011, the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) posted online this Blueprint for Prescriber Continuing Education, labeled "final," relating to extended-release and long-acting opioids. The pending FDA Risk Evaluation Management Strategy (REMS) requires prescriber education. This document provides guidance to sponsors of these dosage forms in developing the prescvriber education component of their REMS. This report was posted online by the federal agency on October 25, 2011 at: http://www.fda.gov/downloads/drugs/drugsafety/informationbydrugclass/ucm277916.pdf. It is in the public domain.

What we know and don't know about the bioeffects of nanoparticles: developing experimental approaches for safety assessment.

PubMed

Stratmeyer, Mel E; Goering, Peter L; Hitchins, Victoria M; Umbreit, Thomas H

2010-08-01

The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) regulates nano-based medical products and therefore is required to address the safety and biological effects of nano-scale materials used in these products. Both in vitro and in vivo toxicological research studies are being conducted at the FDA to help determine the risks versus benefits of these new products. This article will briefly summarize some of the initial research findings from FDA-CDRH studies using TiO(2), polystyrene, and silicon nanoparticles.

Evaluation of radiation exposure from diagnostic radiology examination; availability of final recommendations--FDA. Notice.

PubMed

1986-02-19

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Recommendations for Evaluation of Radiation Exposure from Diagnostic Radiology Examinations". The recommendations, prepared by FDA's Center for Devices and Radiological Health (CDRH), encourage diagnostic radiology facilities to take voluntary action to: Become aware of the radiation levels experienced by patients undergoing the projections commonly given in the facility; compare their radiation levels to generally accepted levels for these projections; and bring the exposures back into line if their levels fall consistently outside these generally accepted levels.

76 FR 13192 - Mark E. Van Wormer: Debarment Order

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-10

...: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic... Medical Center, also known as the Union County Medical, Diagnostic Imaging and Laser Surgery Center, PC...

Final priority; National Institute on Disability and Rehabilitation Research--Rehabilitation Engineering Research Centers. Final priority.

PubMed

2014-06-05

The Assistant Secretary for Special Education and Rehabilitative Services announces a priority for the Disability and Rehabilitation Research Projects and Centers Program administered by the National Institute on Disability and Rehabilitation Research (NIDRR). Specifically, we announce a priority for a Rehabilitation Engineering Research Center (RERC) on Technologies to Enhance Independence in Daily Living for Adults with Cognitive Impairments. The Assistant Secretary may use this priority for competitions in fiscal year (FY) 2014 and later years. We take this action to focus research attention on an area of national need. We intend the priority to contribute to improved outcomes related to independence in daily activities in the home, community, or workplace setting for adults with cognitive impairments.

Final priority; National Institute on Disability and Rehabilitation Research--Rehabilitation Engineering Research Centers. Final priority.

PubMed

2014-07-09

The Assistant Secretary for Special Education and Rehabilitative Services announces a priority under the Disability and Rehabilitation Research Projects and Centers Program administered by the National Institute on Disability and Rehabilitation Research (NIDRR). Specifically, we announce a priority for a Rehabilitation Engineering Research Center (RERC) on Improving the Accessibility, Usability, and Performance of Technology for Individuals who are Deaf or Hard of Hearing. The Assistant Secretary may use this priority for competitions in fiscal year (FY) 2014 and later years. We take this action to focus research attention on an area of national need. We intend the priority to contribute to improving the accessibility, usability, and performance of technology for individuals who are deaf or hard of hearing.

Trends in internet search activity, media coverage, and patient-centered health information after the FDA safety communications on surgical mesh for pelvic organ prolapse.

PubMed

Stone, Benjamin V; Forde, James C; Levit, Valerie B; Lee, Richard K; Te, Alexis E; Chughtai, Bilal

2016-11-01

In July 2011, the US Food and Drug Administration (FDA) issued a safety communication regarding serious complications associated with surgical mesh for pelvic organ prolapse, prompting increased media and public attention. This study sought to analyze internet search activity and news article volume after this FDA warning and to evaluate the quality of websites providing patient-centered information. Google Trends™ was utilized to evaluate search engine trends for the term "pelvic organ prolapse" and associated terms between 1 January 2004 and 31 December 2014. Google News™ was utilized to quantify the number of news articles annually under the term "pelvic organ prolapse." The search results for the term "pelvic organ prolapse" were assessed for quality using the Health On the Net Foundation (HON) certification. There was a significant increase in search activity from 37.42 in 2010 to 57.75 in 2011, at the time of the FDA communication (p = 0.021). No other annual interval had a statistically significant increase in search activity. The single highest monthly search activity, given the value of 100, was August 2011, immediately following the July 2011 notification, with the next highest value being 98 in July 2011. Linear regression analysis of news articles per year since the FDA communication revealed r 2  = 0.88, with a coefficient of 186. Quality assessment demonstrated that 42 % of websites were HON-certified, with .gov sites providing the highest quality information. Although the 2011 FDA safety communication on surgical mesh was associated with increased public and media attention, the quality of relevant health information on the internet remains of poor quality. Future quality assurance measures may be critical in enabling patients to play active roles in their own healthcare.

Patient-centered priorities for improving medication management and adherence.

PubMed

McMullen, Carmit K; Safford, Monika M; Bosworth, Hayden B; Phansalkar, Shobha; Leong, Amye; Fagan, Maureen B; Trontell, Anne; Rumptz, Maureen; Vandermeer, Meredith L; Brinkman, William B; Burkholder, Rebecca; Frank, Lori; Hommel, Kevin; Mathews, Robin; Hornbrook, Mark C; Seid, Michael; Fordis, Michael; Lambert, Bruce; McElwee, Newell; Singh, Jasvinder A

2015-01-01

The Centers for Education and Research on Therapeutics convened a workshop to examine the scientific evidence on medication adherence interventions from the patient-centered perspective and to explore the potential of patient-centered medication management to improve chronic disease treatment. Patients, providers, researchers, and other stakeholders (N = 28) identified and prioritized ideas for future research and practice. We analyzed stakeholder voting on priorities and reviewed themes in workshop discussions. Ten priority areas emerged. Three areas were highly rated by all stakeholder groups: creating tools and systems to facilitate and evaluate patient-centered medication management plans; developing training on patient-centered prescribing for providers; and increasing patients' knowledge about medication management. However, priorities differed across stakeholder groups. Notably, patients prioritized using peer support to improve medication management while researchers did not. Engaging multiple stakeholders in setting a patient-centered research agenda and broadening the scope of adherence interventions to include other aspects of medication management resulted in priorities outside the traditional scope of adherence research. Workshop participants recognized the potential benefits of patient-centered medication management but also identified many challenges to implementation that require additional research and innovation. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Final priority; Technical Assistance on State Data Collection--IDEA Data Management Center. Final priority.

PubMed

2014-08-05

The Assistant Secretary for the Office of Special Education and Rehabilitative Services (OSERS) announces a priority under the Technical Assistance on State Data Collection program. The Assistant Secretary may use this priority for competitions in fiscal year (FY) 2014 and later years. We take this action to fund a cooperative agreement to establish and operate an IDEA Data Management Center (Center) that will provide technical assistance (TA) to improve the capacity of States to meet the data collection requirements of the Individuals with Disabilities Education Act (IDEA).

Applying radio-frequency identification (RFID) technology in transfusion medicine.

PubMed

Hohberger, Clive; Davis, Rodeina; Briggs, Lynne; Gutierrez, Alfonso; Veeramani, Dhamaraj

2012-05-01

ISO/IEC 18000-3 mode 1 standard 13.56 MHz RFID tags have been accepted by the International Society for Blood Transfusion (ISBT) and the United States Food and Drug Administration (FDA) as data carriers to integrate with and augment ISBT 128 barcode data carried on blood products. The use of 13.56 MHz RFID carrying ISBT 128 data structures allows the global deployment and use of RFID, supporting both international transfer of blood and international disaster relief. The deployment in process at the BloodCenter of Wisconsin and testing at the University of Iowa Health Center is the first FDA-permitted implementation of RFID throughout in all phases of blood banking, donation through transfusion. RFID technology and equipment selection will be discussed along with FDA-required RF safety testing; integration with the blood enterprise computing system and required RFID tag performance. Tag design and survivability is an issue due to blood bag centrifugation and irradiation. Deployment issues will be discussed. Use of RFID results in significant return on investment over the use of barcodes in the blood center operations through labor savings and error reduction. Copyright © 2011 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

Real-World Evidence, Public Participation, and the FDA.

PubMed

Schwartz, Jason L

2017-11-01

For observers of pharmaceutical regulation and the Food and Drug Administration, these are uncertain times. Events in late 2016 raised concerns that the FDA's evidentiary standards were being weakened, compromising the agency's ability to adequately perform its regulatory and public health responsibilities. Two developments most directly contributed to these fears-the approval of eteplirsen, a treatment for Duchenne muscular dystrophy, against the recommendations of both FDA staff and an advisory committee and the December 2016 signing of the 21st Century Cures Act, which encouraged greater use by the FDA of "real-world" evidence not obtained through randomized controlled trials. The arrival of the Trump administration-with its deregulatory, industry-friendly approach-has only amplified concerns over the future of the FDA. It is too early to know whether the recent developments are truly harbingers of an FDA less likely to prevent unsafe or ineffective products from reaching the market. But elements in the two events-the role of patient narratives in deliberations regarding eteplirsen and the enthusiasm for real-world evidence in the 21st Century Cures Act-raise critical issues for the future of evidence in the FDA's work. The rigorous, inclusive approach under way to consider issues related to real-world evidence provides a model for a similarly needed inquiry regarding public participation in FDA decision-making. © 2017 The Hastings Center.

77 FR 59930 - Clinical Development Programs for Disease-Modifying Agents for Peripheral Neuropathy; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-01

... for comments. SUMMARY: The Food and Drug Administration (FDA), Center for Drug Evaluation and Research... Contacts: Randi Clark, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver...

Pharmacogenomics in the assessment of therapeutic risks versus benefits: inside the United States Food and Drug Administration.

PubMed

Zineh, Issam; Pacanowski, Michael A

2011-08-01

Pharmacogenomics is the study of how genetic variations influence responses to drugs, diagnostics, or biologic agents. The field of pharmacogenomics has significant potential to enhance drug development and aid in making regulatory decisions. The United States Food and Drug Administration (FDA) has supported pharmacogenomics for nearly a decade by providing regulatory advice and reviewing applications, with the intent of discovering and applying genetic determinants of treatment effects. The FDA will continue to develop policies and processes centered on genomics and individualized therapeutics to guide rational drug development. It will also continue to inform the public of clinically relevant pharmacogenomic issues through various mechanisms of communication, such as drug labeling. In this review, we provide a perspective on several pharmacogenomic activities at the FDA. In addition, we attempt to clarify what we believe are several misperceptions regarding the FDA's pharmacogenomic initiatives. We hope this perspective provides a window into some ways in which the FDA is enabling individualized therapeutics through its mission-critical activities.

A Comparative Review of Marketing Authorization Decisions in Switzerland, the EU, and the USA.

PubMed

Dalla Torre Di Sanguinetto, Simon; Heinonen, Esa; Antonov, Janine; Bolte, Claus

2018-01-01

In this study we compared Swissmedic's (SMC's) regulatory marketing authorization decisions to those of the US Food and Drug Administration (FDA) and European drug regulatory authorities (EU). We investigated the overall similarity of the regulatory decisions, approval, and postmarketing withdrawal rates in the 3 jurisdictions. In case regulatory decisions diverged, we analyzed the reasons for rejection of marketing authorization applications (MAAs). The study comprises 255 new molecular entity (NME) MAAs assessed by SMC by the EU and FDA between 2005 through 2014. Study parameters included the regulatory decision, postmarketing withdrawal rates, and the official reasons for rejection. Regulatory decisions converged to a high degree among all 3 agencies (between 84% and 90%). SMC's average approval rate (84%) was slightly lower than those of the FDA (87%) and the EU (91%). Postmarketing withdrawal rates were generally low (4%-5%) but were 3 to 5 times higher when decisions among the drug regulatory authorities (DRAs) diverged. SMC's primary grounds for rejection were lack of efficacy (45%) and safety (40%). The 3 investigated DRAs adhere largely to the same scientific principles and regulatory guidelines; therefore, remaining disparities ought to be considered in a cultural, legal and public health priority context.

Institutional corruption of pharmaceuticals and the myth of safe and effective drugs.

PubMed

Light, Donald W; Lexchin, Joel; Darrow, Jonathan J

2013-01-01

Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDA's prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication; independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few, if any, new clinical benefits; and the creation of a National Drug Safety Board. © 2013 American Society of Law, Medicine & Ethics, Inc.

Radiation countermeasure agents: an update (2011 – 2014)

PubMed Central

Newman, Victoria L; Romaine, Patricia LP; Wise, Stephen Y; Seed, Thomas M

2014-01-01

Introduction Despite significant scientific advances over the past 60 years towards the development of a safe, nontoxic and effective radiation countermeasure for the acute radiation syndrome (ARS), no drug has been approved by the US FDA. A radiation countermeasure to protect the population at large from the effects of lethal radiation exposure remains a significant unmet medical need of the US citizenry and, thus, has been recognized as a high priority area by the government. Area covered This article reviews relevant publications and patents for recent developments and progress for potential ARS treatments in the area of radiation countermeasures. Emphasis is placed on the advanced development of existing agents since 2011 and new agents identified as radiation countermeasure for ARS during this period. Expert opinion A number of promising radiation countermeasures are currently under development, seven of which have received US FDA investigational new drug status for clinical investigation. Four of these agents, CBLB502, Ex-RAD, HemaMax and OrbeShield, are progressing with large animal studies and clinical trials. G-CSF has high potential and well-documented therapeutic effects in countering myelosuppression and may receive full licensing approval by the US FDA in the future. PMID:25315070

Final priority; technical assistance to improve state data capacity--National Technical Assistance Center to improve state capacity to accurately collect and report IDEA data. Final priority.

PubMed

2013-05-20

The Assistant Secretary for Special Education and Rehabilitative Services announces a priority under the Technical Assistance to Improve State Data Capacity program. The Assistant Secretary may use this priority for competitions in fiscal year (FY) 2013 and later years. We take this action to focus attention on an identified national need to provide technical assistance (TA) to States to improve their capacity to meet the data collection and reporting requirements of the Individuals with Disabilities Education Act (IDEA). We intend this priority to establish a TA center to improve State capacity to accurately collect and report IDEA data (Data Center).

78 FR 28543 - Proposed Priority-National Institute on Disability and Rehabilitation Research-Rehabilitation...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-15

... Institute on Disability and Rehabilitation Research--Rehabilitation Research and Training Centers AGENCY... priority under the Rehabilitation Research and Training Center (RRTC) Program administered by the National Institute on Disability and Rehabilitation Research (NIDRR). Specifically, this notice proposes a priority...

78 FR 26560 - Proposed Priority-National Institute on Disability and Rehabilitation Research-Rehabilitation...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-07

... Institute on Disability and Rehabilitation Research--Rehabilitation Research and Training Centers AGENCY... priority for the Rehabilitation Research and Training Center (RRTC) Program administered by the National Institute on Disability and Rehabilitation Research (NIDRR). Specifically, this notice proposes a priority...

The nightmare of FDA clearance/approval to market: perception or reality?

PubMed

Tylenda, C A

1996-09-01

Over the last few years the Center for Device Evaluation and Research (CDRH) at the Food and Drug Administration (FDA) has received annually over 16 thousand submissions related to medical devices. Over 10,000 of these are major submissions which include applications to conduct clinical trials and applications to market medical devices for a specified indication for use. Each application is carefully considered. FDA personnel work closely with applicants to ensure that clinical trial design minimizes risk to the patients and maximizes benefit with respect to addressing the safety and effectiveness of the device being tested. Applicants are given every opportunity to provide additional information when necessary to assure that applications to market medical devices are complete. Applicants have the opportunity to meet with FDA staff prior to submitting applications in cases where the application is other than a straight forward, uncomplicated submission. In addition, FDA assists applicants through the development of guidance documents, which discuss the type of information that would be beneficial to include in a submission. The Division of Small Manufacturers Assistance at FDA is dedicated to helping interested persons understand the clearance/approval process. This paper will discuss the role of FDA in the regulation of medical devices, with an emphasis on the pathway to obtaining permission to market medical devices in the United States.

US FDA review and regulation of preventive vaccines for infectious disease indications: impact of the FDA Amendments Act 2007.

PubMed

Gruber, Marion F

2011-07-01

Vaccines for prevention or treatment of infectious diseases are biological products that are regulated by the Office of Vaccines Research and Review in the Center for Biologics Evaluation and Research of the US FDA. The legal framework for the regulation of vaccines derives primarily from Section 351 of the Public Health Service Act and from certain sections of the Federal Food, Drug and Cosmetic Act (FFD & C Act). The FDA Amendments Act of 2007 (FDAAA 2007) includes extensive modifications to the FFD & C Act. This article provides an overview of the review process for preventive vaccines and highlights applicable statutory provisions. In addition, this article will discuss changes in the pre-and post-licensure evaluation process for preventive and therapeutic infectious disease vaccines since implementation of the FDAAA 2007.

78 FR 27036 - Final Priority. National Institute on Disability and Rehabilitation Research-Traumatic Brain...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-09

... individuals with disabilities in conducting TBIMS research. Types of Priorities When inviting applications for... Rehabilitation Research--Traumatic Brain Injury Model Systems Centers Collaborative Research Project AGENCY... Services announces a priority for the Disability and Rehabilitation Research Projects and Centers Program...

76 FR 37341 - Final Priority; Rehabilitation Research and Training Center-Interventions To Promote Community...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-27

... research, demonstration projects, training, and related activities, to develop methods, procedures, and... DEPARTMENT OF EDUCATION [CFDA Number: 84.133B-1] Final Priority; Rehabilitation Research and... priority for a Rehabilitation Research and Training Center (RRTC) on Interventions to Promote Community...

76 FR 17396 - Proposed Priorities: Disability and Rehabilitation Research Projects and Centers Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-29

...-science conference on its designated priority research area in the fourth year of the project period, and... Rehabilitation Research Projects and Centers Program AGENCY: Office of Special Education and Rehabilitative... and Rehabilitative Services proposes two priorities for the Disability and Rehabilitation Research...

75 FR 34249 - Centers for Independent Living Program-Training and Technical Assistance

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-16

... rural settings. To meet this priority, applicants must demonstrate all of the following in their... and Rehabilitative Services, Department of Education. ACTION: Notice of final priority. SUMMARY: The Assistant Secretary for Special Education and Rehabilitative Services announces a priority under the Centers...

Development of vaccines for bio-warfare agents.

PubMed

Rosenthal, S R; Clifford, J C M

2002-01-01

There is a recognized need for the development of new vaccines (as well as other biologicals and drugs) to counteract the effects of a potential bio-terrorist or bio-warfare event in the U.S. domestic population and military forces. Regulation of products to protect against potential bio-warfare agents poses unique challenges since the usual measures of efficacy that require exposure to natural disease may not currently be possible, for epidemiological and ethical reasons. To help to address this issue, the FDA has published and requested comments on a proposed animal rule intended to address certain efficacy issues for new agents for use against lethal or permanently disabling toxic substances. Recent product development activity has focused on Bacillus anthracis (anthrax) and variola major (smallpox), agents that are regarded as highest priority in posing a risk to national security. FDA resources exist to assist vaccine developers with regard to the novel challenges posed in the dinical development of these products.

Piloting social engagement on a federal agency-administered Facebook page.

PubMed

Chiu, Kimberly; Wagner, Lindsay; Choe, Lena; Chew, Catherine; Kremzner, Mary

2016-01-01

To evaluate the impact of a Federal drug information center initiating engagement with stakeholders on a Facebook Page administered by a Federal Agency. The U.S. Food and Drug Administration (FDA) Facebook page from July 21, 2014, to October 18, 2014. FDA's Division of Drug Information (DDI) in the Center for Drug Evaluation and Research (CDER) Office of Communications serves as a federal drug information center providing timely, accurate, and useful information on CDER initiatives and CDER-regulated products. We report a 90-day (July 21 to October 18, 2014) pilot during which DDI pharmacists monitored and moderated comments received on FDA's Facebook page to identify those warranting a reply. Once identified, DDI pharmacists replied within 2 business days. Impact was measured by comparing the average number of Likes, Shares, and Reach for Facebook posts before and after the pilot. Additional metrics collected include the number of DDI replies provided to stakeholders' comments and the number of DDI replies provided on time (within 2 business days). During the pilot, DDI contributed 14 posts. On average, each post reached 23,582 more individuals (an increase of 187% compared with pre-pilot posts). On average, each post also received 463 more Likes (450% increase) and 130 more Shares (271% increase). DDI pharmacists replied to 3% (121/3994) and hid 0.58% (23/3994) of Facebook comments received during the 90-day period. All actions were taken within 2 business days. Initiating social engagement had a positive impact on FDA's Facebook page. Published by Elsevier Inc.

In vitro exposure systems and dosimetry assessment tools for inhaled tobacco products: Workshop proceedings, conclusions and paths forward for in vitro model use.

PubMed

Behrsing, Holger; Hill, Erin; Raabe, Hans; Tice, Raymond; Fitzpatrick, Suzanne; Devlin, Robert; Pinkerton, Kent; Oberdörster, Günter; Wright, Chris; Wieczorek, Roman; Aufderheide, Michaela; Steiner, Sandro; Krebs, Tobias; Asgharian, Bahman; Corley, Richard; Oldham, Michael; Adamson, Jason; Li, Xiang; Rahman, Irfan; Grego, Sonia; Chu, Pei-Hsuan; McCullough, Shaun; Curren, Rodger

2017-07-01

In 2009, the passing of the Family Smoking Prevention and Tobacco Control Act facilitated the establishment of the FDA Center for Tobacco Products (CTP), and gave it regulatory authority over the marketing, manufacture and distribution of tobacco products, including those termed 'modified risk'. On 4-6 April 2016, the Institute for In Vitro Sciences, Inc. (IIVS) convened a workshop conference entitled, In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products, to bring together stakeholders representing regulatory agencies, academia and industry to address the research priorities articulated by the FDA CTP. Specific topics were covered to assess the status of current in vitro smoke and aerosol/vapour exposure systems, as well as the various approaches and challenges to quantifying the complex exposures in in vitro pulmonary models developed for evaluating adverse pulmonary events resulting from tobacco product exposures. The four core topics covered were: a) Tobacco Smoke and E-Cigarette Aerosols; b) Air-Liquid Interface-In Vitro Exposure Systems; c) Dosimetry Approaches for Particles and Vapours/In Vitro Dosimetry Determinations; and d) Exposure Microenvironment/Physiology of Cells. The 2.5-day workshop included presentations from 20 expert speakers, poster sessions, networking discussions, and breakout sessions which identified key findings and provided recommendations to advance these technologies. Here, we will report on the proceedings, recommendations, and outcome of the April 2016 technical workshop, including paths forward for developing and validating non-animal test methods for tobacco product smoke and next generation tobacco product aerosol/vapour exposures. With the recent FDA publication of the final deeming rule for the governance of tobacco products, there is an unprecedented necessity to evaluate a very large number of tobacco-based products and ingredients. The questionable relevance, high cost, and ethical considerations for the use of in vivo testing methods highlight the necessity of robust in vitro approaches to elucidate tobacco-based exposures and how they may lead to pulmonary diseases that contribute to lung exposure-induced mortality worldwide. 2017 FRAME.

77 FR 21982 - Request for Notification From Industry Organizations Interested in Participating in the Selection...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-12

... Products Advisory Committee for the Center for Biologics Evaluation and Research (CBER) notify FDA in...). FOR FURTHER INFORMATION CONTACT: Bryan Emery, Center for Biologics Evaluation and Research, Food and... Center for Biologics Evaluation and Research Members are selected by the Commissioner of Food and Drugs...

76 FR 71045 - Center for Biologics Evaluation and Research Report of Scientific and Medical Literature and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-16

... and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug... CONTACT: Paul E. Levine, Jr., Center for Biologics Evaluation and Research (HFM-17), Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0599...

Off-label use of medical products in radiation therapy: Summary of the Report of AAPM Task Group No. 121

DOE Office of Scientific and Technical Information (OSTI.GOV)

Thomadsen, Bruce R.; Thompson, Heaton H. II; Jani, Shirish K.

Medical products (devices, drugs, or biologics) contain information in their labeling regarding the manner in which the manufacturer has determined that the products can be used in a safe and effective manner. The Food and Drug Administration (FDA) approves medical products for use for these specific indications which are part of the medical product's labeling. When medical products are used in a manner not specified in the labeling, it is commonly referred to as off-label use. The practice of medicine allows for this off-label use to treat individual patients, but the ethical and legal implications for such unapproved use canmore » be confusing. Although the responsibility and, ultimately, the liability for off-label use often rests with the prescribing physician, medical physicists and others are also responsible for the safe and proper use of the medical products. When these products are used for purposes other than which they were approved, it is important for medical physicists to understand their responsibilities. In the United States, medical products can only be marketed if officially cleared, approved, or licensed by the FDA; they can be used if they are not subject to or specifically exempt from FDA regulations, or if they are being used in research with the appropriate regulatory safeguards. Medical devices are either cleared or approved by FDA's Center for Devices and Radiological Health. Drugs are approved by FDA's Center for Drug Evaluation and Research, and biological products such as vaccines or blood are licensed under a biologics license agreement by FDA's Center for Biologics Evaluation and Research. For the purpose of this report, the process by which the FDA eventually clears, approves, or licenses such products for marketing in the United States will be referred to as approval. This report summarizes the various ways medical products, primarily medical devices, can legally be brought to market in the United States, and includes a discussion of the approval process, along with manufacturers' responsibilities, labeling, marketing and promotion, and off-label use. This is an educational and descriptive report and does not contain prescriptive recommendations. This report addresses the role of the medical physicist in clinical situations involving off-label use. Case studies in radiation therapy are presented. Any mention of commercial products is for identification only; it does not imply recommendations or endorsements of any of the authors or the AAPM. The full report, containing extensive background on off-label use with several appendices, is available on the AAPM website (http://www.aapm.org/pubs/reports/).« less

Awareness of the role of science in the FDA regulatory submission process: a survey of the TERMIS-Americas membership.

PubMed

Johnson, Peter C; Bertram, Tim A; Carty, Neal R; Hellman, Kiki B; Tawil, Bill J; Van Dyke, Mark

2014-06-01

The Industry Committee of the Tissue Engineering Regenerative Medicine International Society, Americas Chapter (TERMIS-AM) administered a survey to its membership in 2013 to assess the awareness of science requirements in the U.S. Food and Drug Administration (FDA) regulatory process. One hundred forty-four members responded to the survey. Their occupational and geographical representation was representative of the TERMIS-AM membership as a whole. The survey elicited basic demographic information, the degree to which members were involved in tissue engineering technology development, and their plans for future involvement in such development. The survey then assessed the awareness of general FDA scientific practices as well as specific science requirements for regulatory submissions to the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), and the Office of Combination Projects (OCP). The FDA-specific questions in the survey were culled from guidance documents posted on the FDA web site ( www.fda.gov ). One of the answer options was an opt-out clause that enabled survey respondents to claim a lack of sufficient awareness of the topic to answer the question. This enabled the stratification of respondents on the basis of confidence in the topic. Results indicate that across all occupational groups (academic, business, and government) that are represented in the TERMIS-AM membership, the awareness of FDA science requirements varies markedly. Those who performed best were for-profit company employees, consultants, and government employees; while students, professors, and respondents from outside the USA performed least well. Confidence in question topics was associated with increased correctness in responses across all groups, though the association between confidence and the ability to answer correctly was poorest among students and professors. Though 80% of respondents claimed involvement in the development of a tissue engineering technology, their responses were no more correct than those who were not. Among those developing tissue engineering technologies, few are taking advantage of existing standards organizations to strengthen their regulatory submissions. The data suggest that early exposure to regulatory experts would be of value for those seeking to bring their technology to the market. For all groups studied but especially for students and professors, formal initial or continuing education in Regulatory Science should be considered to best support translational tissue engineering research and development. In addition, the involvement of standards development organizations during tissue engineering technology development is strongly recommended.

A review of complications associated with vertebroplasty and kyphoplasty as reported to the Food and Drug Administration medical device related web site.

PubMed

Nussbaum, David A; Gailloud, Philippe; Murphy, Kieran

2004-11-01

In 2002, approximately 38,000 vertebroplasties and 16,000 kyphoplasties were performed in the United States. As the use of both modalities for the treatment of vertebral compression fractures has increased, so have questions regarding safety and efficacy. The authors addressed this by reviewing both the current literature and complications data reported to the Food and Drug Administration (FDA) Center for Devices and Radiological Health through the on-line database (http://www.fda.gov/cdrh/maude.html) and through the Office of the Freedom of Information Act at the FDA. Although both procedures are largely safe, the FDA data highlight two main concerns: reactions to the use of acrylic (polymethylmethacrylate) bone cement, including hypotension and, in some cases, death, especially when multiple vertebral levels are treated in one setting; and a possible increased risk with kyphoplasty of pedicle fracture and cord compression.

Design considerations, architecture, and use of the Mini-Sentinel distributed data system.

PubMed

Curtis, Lesley H; Weiner, Mark G; Boudreau, Denise M; Cooper, William O; Daniel, Gregory W; Nair, Vinit P; Raebel, Marsha A; Beaulieu, Nicolas U; Rosofsky, Robert; Woodworth, Tiffany S; Brown, Jeffrey S

2012-01-01

We describe the design, implementation, and use of a large, multiorganizational distributed database developed to support the Mini-Sentinel Pilot Program of the US Food and Drug Administration (FDA). As envisioned by the US FDA, this implementation will inform and facilitate the development of an active surveillance system for monitoring the safety of medical products (drugs, biologics, and devices) in the USA. A common data model was designed to address the priorities of the Mini-Sentinel Pilot and to leverage the experience and data of participating organizations and data partners. A review of existing common data models informed the process. Each participating organization designed a process to extract, transform, and load its source data, applying the common data model to create the Mini-Sentinel Distributed Database. Transformed data were characterized and evaluated using a series of programs developed centrally and executed locally by participating organizations. A secure communications portal was designed to facilitate queries of the Mini-Sentinel Distributed Database and transfer of confidential data, analytic tools were developed to facilitate rapid response to common questions, and distributed querying software was implemented to facilitate rapid querying of summary data. As of July 2011, information on 99,260,976 health plan members was included in the Mini-Sentinel Distributed Database. The database includes 316,009,067 person-years of observation time, with members contributing, on average, 27.0 months of observation time. All data partners have successfully executed distributed code and returned findings to the Mini-Sentinel Operations Center. This work demonstrates the feasibility of building a large, multiorganizational distributed data system in which organizations retain possession of their data that are used in an active surveillance system. Copyright © 2012 John Wiley & Sons, Ltd.

Excimer laser photorefractive keratectomy for myopia: preliminary results at one year

NASA Astrophysics Data System (ADS)

Thompson, Keith P.; Waring, George O., III; Steinert, Roger; Durrie, Daniel S.; Gordon, Michael; Brint, Stephen F.

1992-08-01

Excimer laser photorefractive keratectomy (PRK) is presently under investigation for the correction of myopia. Two companies in the United States, Summit Technology (Waltham, Mass.) and VisX, Inc. (Sunnyvale, Calif.) have developed excimer laser delivery systems and are participating in an FDA study to determine the safety and efficacy of PRK. This is a preliminary report on the refractive and visual results of 51 of 100 eyes treated between October 10, 1990 and March 7, 1991 by the Summit Technology UV200LA excimer laser under the FDA Phase IIB FDA protocol one year after surgery. More detailed information on eight patients treated at Emory University Eye Center (Emory Subgroup) is also reported.

78 FR 34897 - Final Priorities; National Institute on Disability and Rehabilitation Research-Disability and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-11

....133E-8.] Final Priorities; National Institute on Disability and Rehabilitation Research--Disability and Rehabilitation Research Projects and Centers Program--Rehabilitation Engineering Research Centers AGENCY: Office... under the Disability and Rehabilitation Research Projects and Centers Program administered by the...

75 FR 384 - Event Problem Codes Web Site; Center for Devices and Radiological Health; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-05

...] Event Problem Codes Web Site; Center for Devices and Radiological Health; Availability AGENCY: Food and... the availability of a Web site where the Center for Devices and Radiological Health (CDRH) is posting... to all reporters (Sec. 803.21(b)). FDA is announcing the availability of a Web site that will make...

77 FR 13131 - Advisory Committees; Filing of Closed Meeting Reports

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-05

..., 2010 through September 30, 2011: Center for Biologics Evaluation and Research Allergenic Products... Vaccines and Related Biological Products Advisory Committee Center for Drug Evaluation and Research... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001...

78 FR 27198 - Applications for New Awards; National Institute on Disability and Rehabilitation Research...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-09

... Rehabilitation Research--Traumatic Brain Injury Model Systems Centers Collaborative Research Project AGENCY... Brain Injury Model Systems Centers Collaborative Research Projects; Notice inviting applications for new... competition. Priority 1, the DRRP Priority for the Traumatic Brain Injury Model Systems Centers Collaborative...

Advertising and promotion of medical devices.

PubMed

Portnoy, Stuart

2006-01-01

Dr. Portnoy, a former senior clinical reviewer and manager for the FDA's Center for Devices and Radiological Health, provides guidance for determining acceptable practices for the claims, content, and appearance of advertising and promotional materials for medical devices. In the course of doing so, he discusses important regulatory and legal precedents, and provides examples of successful and problematic advertising and promotion strategies including those that resulted in FDA Warning Letters, enforcement activities, and in some cases, monetary and criminal penalties.

21 CFR 100.2 - State enforcement of Federal regulations.

Code of Federal Regulations, 2010 CFR

2010-04-01

...-605), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch... Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD... notification was received by FDA, Center for Food Safety and Applied Nutrition, Division of Enforcement (HFS...

21 CFR 100.2 - State enforcement of Federal regulations.

Code of Federal Regulations, 2011 CFR

2011-04-01

...-605), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch... Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD... notification was received by FDA, Center for Food Safety and Applied Nutrition, Division of Enforcement (HFS...

21 CFR 100.2 - State enforcement of Federal regulations.

Code of Federal Regulations, 2012 CFR

2012-04-01

...-605), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch... Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD... notification was received by FDA, Center for Food Safety and Applied Nutrition, Division of Enforcement (HFS...

21 CFR 100.2 - State enforcement of Federal regulations.

Code of Federal Regulations, 2014 CFR

2014-04-01

...-605), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch... Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD... notification was received by FDA, Center for Food Safety and Applied Nutrition, Division of Enforcement (HFS...

21 CFR 100.2 - State enforcement of Federal regulations.

Code of Federal Regulations, 2013 CFR

2013-04-01

...-605), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch... Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD... notification was received by FDA, Center for Food Safety and Applied Nutrition, Division of Enforcement (HFS...

78 FR 15371 - Drug Development for Chronic Fatigue Syndrome and Myalgic Encephalomyelitis; Public Workshop

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-11

... and Drug Administration (FDA), Center for Drug Evaluation and Research, is announcing a public..., patient advocates, patients, and clinicians on how to identify sound, quantitative outcome measures that.... Contact Persons: Mary Gross, Center for Drug Evaluation and Research, Food and Drug Administration, 10903...

21 CFR 312.48 - Dispute resolution.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Dispute resolution. 312.48 Section 312.48 Food and... division in FDA's Center for Drug Evaluation and Research or Center for Biologics Evaluation and Research... 20. (c) Scientific and medical disputes. (1) When scientific or medical disputes arise during the...

75 FR 6035 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0043... Center for Veterinary Medicine AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... format to the Center for Veterinary Medicine (CVM). DATES: Submit written or electronic comments on the...

75 FR 6037 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0034... Slaughter in Electronic Format to the Center for Veterinary Medicine AGENCY: Food and Drug Administration... Format to the Center for Veterinary Medicine.'' DATES: Submit written or electronic comments on the...

75 FR 6038 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0057... How to Submit Information in Electronic Format to the Center for Veterinary Medicine Using the Food... on the reporting requirements for the Center for Veterinary Medicine's (CVM's) ``Guidance for...

77 FR 41391 - Final Priority; Rehabilitation Research and Training Center on Vocational Rehabilitation and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-13

... Research and Training Center (RRTCs) on Vocational Rehabilitation (VR) and Developing Strategies to Meet... Projects and Centers Program administered by NIDRR. Specifically, this priority is for an RRTC on VR and... effective VR practices that take into account economic conditions, labor market trends, and employer needs...

An analysis of the FDA Food Safety Modernization Act: protection for consumers and boon for business.

PubMed

Strauss, Debra M

2011-01-01

This article analyzes components of the FDA Food Safety Modernization Act, which was prompted by incidents of food contamination, exploring the history of its passage and explaining its significance, as well as its limitations. As the first time in 70 years that food law has been changed substantially, this new law represents only an initial but significant step in the direction of improving food safety. With bipartisan support from both Congress and the President, this legislation embodies a mandate that food safety is at this moment becoming a priority. As a result, the time is ripe for a reassessment of other areas of food laws--particularly genetically modified foods and the use of milk and meat from cloned animals and their progeny--which are allowed under current U.S. law with no labeling, preapprovals, or post-market monitoring. These areas warrant special regulation consistent with the new proactive policy towards securing the safety of the food supply.

Research gaps related to tobacco product marketing and sales in the Family Smoking Prevention and Tobacco Control Act.

PubMed

Ribisl, Kurt M

2012-01-01

This paper is part of a collection that identifies research priorities that will help guide the efforts of the U.S. Food and Drug Administration (FDA) as it regulates tobacco products. This paper examines the major provisions related to tobacco product advertising, marketing, sales, and distribution included in Public Law 111-31, the "Family Smoking Prevention and Tobacco Control Act". This paper covers 5 areas related to (a) marketing regulations (e.g., ban on color and imagery in ads, ban on nontobacco gifts with purchase); (b) granting FDA authority over the sale, distribution, accessibility, advertising, and promotion of tobacco and lifting state preemption over advertising; (c) remote tobacco sales (mail order and Internet); (d) prevention of illicit and cross-border trade; and (e) noncompliant export products. Each of the 5 sections of this paper provides a description and brief history of regulation, what is known about this regulatory strategy, and research opportunities.

Interchangeability, Safety and Efficacy of Modified-Release Drug Formulations in the USA: The Case of Opioid and Other Nervous System Drugs.

PubMed

Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Hansen, Richard

2016-04-01

Modified-release drugs may provide clinical advantages compared to immediate-release forms and improve convenience to the patient and health outcomes. Concerns have been raised regarding interchangeability, efficacy, and safety of modified-release formulations. This study analyses all US Food and Drug Administration (FDA)-approved modified-release formulations and market trends, and illustrates how bioequivalence and safety of generic modified-release products compare to their respective brand name drugs and other generic drugs with different formulation design characteristics. This study also examines major concerns related to modified-release formulations: safety of opioids and bioequivalence of generic bupropion and methylphenidate. Study data were derived from the FDA electronic versions of the FDA's Orange Book (OB) and the FDA safety communications web page. Medicare Part D utilization and expenditures data were extracted from the Centers for Medicare and Medicaid. In May 2015, 276 (11.9 %) of the 2325 active ingredients and fixed-dose combinations listed in the FDA's Orange Book had at least one modified-release form approved by the FDA. The number of approvals increased over time; 52.5 % of modified releases were approved in the period 2000-May 2015. The FDA required a risk evaluation and mitigation strategy (REMS) to ensure that the benefits of extended-release opioids outweighed its risks of overdose and abuse. The REMS involved 16 new drug applications and 25 abbreviated new drug applications. The FDA addressed interchangeability problems with generic modified-release alternatives of bupropion and methylphenidate including lack of bioequivalence, reduced efficacy, and increased incidence of adverse events. Systematic post-marketing surveillance studies are needed to assess differences in safety, interchangeability, and efficacy of drugs with modified- and immediate-release formulations.

Aspartame intolerance.

PubMed

Garriga, M M; Metcalfe, D D

1988-12-01

Aspartame is a food additive marketed under the brand name Nutrasweet. Aspartame is a white, odorless, crystalline powder and consists of two amino acids, L-aspartic acid and L-phenylalanine. It is 180 times as sweet as sugar. The Food and Drug Administration (FDA) first allowed its use in dry foods in July 1981 and then approved its use in carbonated beverages in July 1983. It has subsequently been approved for use in a number of materials including multivitamins, fruit juices, stick-type confections, breath mints, and iced tea. The FDA requires the statement "phenylketonurics: contains phenylalanine" on labels of food products containing aspartame because individuals with phenylketonuria (PKU) must restrict their intake of phenylalanine. Aspartame is judged to be free of long-term cancer risks. Aspartame is not stable under certain conditions including baking and cooking, and prolonged exposure to acid conditions. In such situations it loses its sweetness. Products formed from aspartame include its component amino acids (phenylalanine and aspartic acid), methanol, and diketopiperazine (DKP). Animal studies show DKP to be nontoxic. Methanol occurs in small amounts and does not exceed that formed during consumption of many foods including fresh fruits and vegetables. FDA's Center for Food Safety and Applied Nutrition (CFSAN) monitors aspartame's safety in part through reports of adverse reactions. After aspartame was approved for use in carbonated beverages, the FDA received an increased number of reports concerning adverse reactions related to aspartame. The Centers for Disease Control (CDC) reviewed these reports, which included complaints of neurologic, gastrointestinal, andallergic reactions.(ABSTRACT TRUNCATED AT 250 WORDS)

Food and Drug Administration: Helping pharmacists ensure that patients receive high-quality medicines.

PubMed

Kremzner, Mary

2016-01-01

Ensuring that the drugs patients take are safe and effective is critical to the Food and Drug Administration (FDA) mission and a major reason for testing an active pharmaceutical ingredient or currently marketed drug product. To address gaps in the assessment of drug quality, FDA's Center for Drug Evaluation and Research (CDER) has created the Office of Pharmaceutical Quality (OPQ). This newly formed "super-office" within CDER launched a concerted new strategy that enhances the surveillance of drug manufacturing and will bring a comprehensive approach to quality oversight. With OPQ and these new performance measures in place, FDA can sharpen its focus on issues critical to quality and can identify and respond to manufacturing issues before they become major systemic problems. Published by Elsevier Inc.

78 FR 7784 - Draft Guidance for Industry on Enrichment Strategies for Clinical Trials To Support Approval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-04

... FURTHER INFORMATION CONTACT: Robert Temple, Center for Drug Evaluation and Research, Food and Drug... Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1145...

78 FR 68854 - Over-the-Counter Ophthalmic Drug Products-Emergency Use Eyewash Products; Rescheduling of Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-15

...: Mary C. Gross, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New... Elaine Abraham, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1038...

76 FR 60505 - Center for Drug Evaluation and Research, Approach to Addressing Drug Shortage; Public Workshop...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0690] Center for Drug Evaluation and Research, Approach to Addressing Drug Shortage; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

77 FR 23485 - Food and Drug Administration Patient Network Annual Meeting; Input Into Food and Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-19

... specific disease area during its meetings with patients? For example, who should serve as representatives of patients? (2) What methodological and practical issues should FDA consider as it develops its... Research and Center for Biologics Evaluation and Research Efforts Center for Drug Evaluation and Research...

77 FR 59929 - Guidance for Industry on Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-01

... the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug... INFORMATION CONTACT: Joseph G. Toerner, Center for Drug Evaluation and Research, Food and Drug Administration... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0419...

77 FR 61417 - Guidance for Industry on Acute Bacterial Sinusitis: Developing Drugs for Treatment; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-09

... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0375...

76 FR 71349 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-17

.... Contact Person: Yvette Waples, Center for Drug Evaluation and Research, Food and Drug Administration... following topics related to the use of ophthalmic drug products (products intended for use in the eye): (1... infection. FDA's Center for Drug Evaluation and Research would like the advisory committee to provide advice...

75 FR 26963 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0043... Electronic Format to the Center for Veterinary Medicine AGENCY: Food and Drug Administration, HHS. ACTION... Submit a Request for a Meeting or Teleconference in Electronic Format to the Center for Veterinary...

75 FR 22598 - Agency Information Collection Activities; Submission for Office and Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0034... Not Intended for Immediate Slaughter in Electronic Format to the Center for Veterinary Medicine AGENCY... Not Intended for Immediate Slaughter in Electronic Format to the Center for Veterinary Medicine--(OMB...

77 FR 18828 - Guidance for Industry and Food and Drug Administration Staff; Factors To Consider When Making...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-28

... Assistance, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New... CONTACT: For devices regulated by CDRH: Ruth Fischer, Center for Devices and Radiological Health, Food and... search capability is available for all CDRH guidance documents at http://www.fda.gov/MedicalDevices...

78 FR 44572 - Draft Guidance for Industry on Pre-Launch Activities Importation Requests; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-24

..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0836...

77 FR 72924 - Taxable Medical Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-07

... as devices by the FDA Center for Biologics Evaluation and Research (CBER). In general, CBER licenses... designed to implant a particular orthopedic joint; (iv) testing and development products; and (v) product...

Centers for Water Research on National Priorities Related to a Systems View of Nutrient Management Kick-off Meeting

EPA Pesticide Factsheets

At this meeting, grantees from Centers for Water Research on National Priorities Related to a Systems View of Nutrient Management and Sustainable Chesapeake: A Community-Based Approach to Stormwater Management Using Green Infrastructure

78 FR 42868 - Final Priority; National Institute on Disability and Rehabilitation Research-Rehabilitation...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-18

... Institute on Disability and Rehabilitation Research--Rehabilitation Research and Training Centers AGENCY... for the Disability and Rehabilitation Research Projects and Centers Program administered by the National Institute on Disability and Rehabilitation Research (NIDRR). Specifically, we announce a priority...

21 CFR 516.13 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Species Animal Drug Development of the FDA Center for Veterinary Medicine. Intended use means the intended treatment, control or prevention of a disease or condition, or the intention to affect the structure or...

A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors

PubMed Central

Shah, Rashmi R; Roberts, Samantha A; Shah, Devron R

2013-01-01

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. PMID:23362829

Citations in Life Science Patents to Publicly Funded Research at Academic Medical Centers.

PubMed

Sampat, Bhaven N; Pincus, Harold Alan

2015-12-01

The contributions of Academic Medical Centers (AMCs) to biomedical innovation have been difficult to measure because of the challenges involved in tracing knowledge flows from their origin to their uses. The authors examined patent citation linkages between AMC research funded by the National Institutes of Health (NIH) and patents. In prospective analyses, they examine the extent to which articles resulting from NIH grants to AMCs awarded between 1990 and 1995 were cited in drug and medical patents. The authors then examine the extent to which these patents are associated with marketed drugs. In retrospective analyses, they examine the share of drugs approved between 2000 and 2009 that have citation links to NIH-funded AMC research. The prospective analyses show over a third of AMC grants resulted in publications that were cited in patents. Most the patents are drug and biotechnology patents, and are assigned to private firms. Patents citing NIH-funded AMC publications were associated with 106 new FDA approved drugs, half of which are new molecular entities and a quarter of which are priority NMEs. The retrospective analyses showed that about half of the new molecular entities approved over the 2000-2009 period had citations links to NIH-funded AMC research. There are strong links between articles from NIH-funded AMC research and private sector medical patenting, including drugs. More research is needed to better understand the types of links the citations represent and their implications for public policy. © 2015 Wiley Periodicals, Inc.

Clomipramine

MedlinePlus

... www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273.No matter your age, before you take an antidepressant, you, ... blue discoloration of the skin fever widened pupils (dark circles in the center of the eye) decreased ...

Practice Hospital Bed Safety

MedlinePlus

... Administration’s (FDA) Center for Devices and Radiological Health (CDRH). "They are used not only in hospitals, but ... long-term care facilities, and in private homes." CDRH reports that about 2.5 million hospital beds ...

75 FR 21270 - Office of Special Education and Rehabilitative Services; Overview Information; National Institute...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-23

... Information; National Institute on Disability and Rehabilitation Research (NIDRR)--Disability and... notice of final priorities for the Disability and Rehabilitation Research Projects and Centers program... priority for the Disability and Rehabilitation Research Projects and Centers Program, published elsewhere...

78 FR 38840 - Final Priority-National Institute on Disability and Rehabilitation Research-Rehabilitation...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-28

... Rehabilitation Research--Rehabilitation Research and Training Centers AGENCY: Office of Special Education and... Disability and Rehabilitation Research Projects and Centers Program administered by the National Institute on Disability and Rehabilitation Research (NIDRR). Specifically, we announce a priority for a Rehabilitation...

Final priority. Rehabilitation Training: Job-Driven Vocational Rehabilitation Technical Assistance Center. Final priority.

PubMed

2014-08-19

The Assistant Secretary for Special Education and Rehabilitative Services announces a priority under the Rehabilitation Training program to establish a Job-Driven Vocational Rehabilitation Technical Assistance Center (JDVRTAC). The Assistant Secretary may use this priority for competitions in fiscal year (FY) 2014 and later years. We take this action to focus on training in an area of national need. Specifically, this priority responds to the Presidential Memorandum to Federal agencies directing them to take action to address job-driven training for the Nation's workers. The JDVRTAC will provide technical assistance (TA) to State vocational rehabilitation (VR) agencies to help them develop for individuals with disabilities training and employment opportunities that meet the needs of today's employers.

75 FR 6401 - Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-09

... premarket approval applications (PMAs) that have been approved by the Center for Biologics Evaluation and Research (CBER). This list is intended to inform the public of the availability through the Internet and... post this information on the Internet at http://www.fda.gov . In addition, the regulations provide that...

76 FR 62072 - Center for Devices and Radiological Health; Standard Operating Procedures for Network of Experts...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-06

...] Center for Devices and Radiological Health; Standard Operating Procedures for Network of Experts; Request... procedures (SOPs) for a new ``Network of Experts.'' The draft SOPs describe a new process for staff at the... FDA is announcing the availability of two draft SOPs, one entitled, ``Network of Experts--Expert...

75 FR 10294 - Strengthening the Center for Devices and Radiological Health's 510(k) Review Process; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-05

...] Strengthening the Center for Devices and Radiological Health's 510(k) Review Process; Public Meeting; Extension...). In the notice, FDA requested comments on a number of identified challenges associated with the 510(k... premarket notification (or 510(k)) process for the review of medical devices. Specific questions for comment...

77 FR 74582 - Small Entity Compliance Guide: What You Need To Know About Registration of Food Facilities...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-17

..., Division of Field Programs and Guidance (HFS-615), Center for Food Safety and Applied Nutrition, Food and..., Office of Compliance, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1 [Docket No FDA...

A Phase II Trial on the Effect of Low-Dose versus High-Dose Vitamin D Supplementation on Bone Mass in Adults with Neurofibromatosis 1 (NF1)

DTIC Science & Technology

2017-10-01

Cincinnati enrollment center CGRP = Clinical Genetics Research Program DEXA = dual energy x-ray absorptiometry Ddrops = formulation of...cholecalciferol (vitamin D3) DXA = dual energy x-ray absorptiometry FDA= Federal Drug Administration HAM = University of Hamburg enrollment center IRB

75 FR 22598 - Agency Information Collection Activities; Submission for Office and Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-29

... Electronic Format to the Center for Veterinary Medicine--(OMB Control Number 0910-0524)--Extension Protocols... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0055... Request; Guidance for Industry on How to Submit a Protocol Without Data in Electronic Format to the Center...

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

... ``Center for Devices and Radiological Health (CDRH) Appeals Processes.'' This document describes the processes available to outside stakeholders to request additional review of decisions and actions by CDRH... submit related requests to CDRH and FDA. This draft guidance is not final nor is it in effect at this...

FDA's perspectives on cardiovascular devices.

PubMed

Chen, Eric A; Patel-Raman, Sonna M; O'Callaghan, Kathryn; Hillebrenner, Matthew G

2009-06-01

The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the health of the public by ensuring the safety and effectiveness of medical devices deemed appropriate for human use (Food, Drug & Cosmetic Act, Section 903(b)(1, 2(C)), December 31, 2004; accessed December 17, 2008 http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm). For high-risk devices, such as ventricular assist devices (VADs), mechanical heart valves, stents, cardiac resynchronization therapy (CRT) devices, pacemakers, and defibrillators, the determination is based on FDA's review of extensive preclinical bench and animal testing followed by use of the device in a clinical trial in humans. These clinical trials allow the manufacturer to evaluate a device in the intended use population. FDA reviews the data from the clinical trial to determine if the device performed as predicted and the clinical benefits outweigh the risks. This article reviews the regulatory framework for different marketing applications related to cardiovascular devices and describes the process of obtaining approval to study a cardiovascular device in a U.S. clinical trial.

75 FR 26952 - National Institute on Disability and Rehabilitation Research (NIDRR)-Disability and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-13

... Social Security Administration, the Centers for Medicare and Medicaid Services, and other agencies, as... Education. ACTION: Notice of proposed priority. SUMMARY: The Assistant Secretary for Special Education and Rehabilitative Services proposes a priority for the Disability and Rehabilitation Research Projects and Centers...

78 FR 20069 - Proposed Priority-National Institute on Disability and Rehabilitation Research (NIDRR...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-03

... contribute to this outcome by emphasizing the principles of universal design in its product research and... Rehabilitation Research (NIDRR)--Rehabilitation Engineering Research Centers (RERCs)--Technologies To Support... priority for the Disability and Rehabilitation Research Projects and Centers Program administered by NIDRR...

78 FR 35886 - Applications for New Awards; National Institute on Disability and Rehabilitation Research...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-14

... Disability and Rehabilitation Research (NIDRR)--Disability and Rehabilitation Research Projects and Centers... notice of final priorities for the Disability and Rehabilitation Research Projects and Centers Program... included in the notice of final priorities for the Disability and Rehabilitation Research Projects and...

Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010

PubMed Central

Downing, Nicholas S.; Shah, Nilay D.; Aminawung, Jenerius A.; Pease, Alison M.; Zeitoun, Jean-David; Krumholz, Harlan M.

2017-01-01

Importance Postmarket safety events of novel pharmaceuticals and biologics occur when new safety risks are identified after initial regulatory approval of these therapeutics. These safety events can change how novel therapeutics are used in clinical practice and inform patient and clinician decision making. Objectives To characterize the frequency of postmarket safety events among novel therapeutics approved by the US Food and Drug Administration (FDA), and to examine whether any novel therapeutic characteristics known at the time of FDA approval were associated with increased risk. Design and Setting Cohort study of all novel therapeutics approved by the FDA between January 1, 2001, and December 31, 2010, followed up through February 28, 2017. Exposures Novel therapeutic characteristics known at the time of FDA approval, including drug class, therapeutic area, priority review, accelerated approval, orphan status, near–regulatory deadline approval, and regulatory review time. Main Outcomes and Measures A composite of (1) withdrawals due to safety concerns, (2) FDA issuance of incremental boxed warnings added in the postmarket period, and (3) FDA issuance of safety communications. Results From 2001 through 2010, the FDA approved 222 novel therapeutics (183 pharmaceuticals and 39 biologics). There were 123 new postmarket safety events (3 withdrawals, 61 boxed warnings, and 59 safety communications) during a median follow-up period of 11.7 years (interquartile range [IQR], 8.7-13.8 years), affecting 71 (32.0%) of the novel therapeutics. The median time from approval to first postmarket safety event was 4.2 years (IQR, 2.5-6.0 years), and the proportion of novel therapeutics affected by a postmarket safety event at 10 years was 30.8% (95% CI, 25.1%-37.5%). In multivariable analysis, postmarket safety events were statistically significantly more frequent among biologics (incidence rate ratio [IRR] = 1.93; 95% CI, 1.06-3.52; P = .03), therapeutics indicated for the treatment of psychiatric disease (IRR = 3.78; 95% CI, 1.77-8.06; P < .001), those receiving accelerated approval (IRR = 2.20; 95% CI, 1.15-4.21; P = .02), and those with near–regulatory deadline approval (IRR = 1.90; 95% CI, 1.19-3.05; P = .008); events were statistically significantly less frequent among those with regulatory review times less than 200 days (IRR = 0.46; 95% CI, 0.24-0.87; P = .02). Conclusions and Relevance Among 222 novel therapeutics approved by the FDA from 2001 through 2010, 32% were affected by a postmarket safety event. Biologics, psychiatric therapeutics, and accelerated and near–regulatory deadline approval were statistically significantly associated with higher rates of events, highlighting the need for continuous monitoring of the safety of novel therapeutics throughout their life cycle. PMID:28492899

Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010.

PubMed

Downing, Nicholas S; Shah, Nilay D; Aminawung, Jenerius A; Pease, Alison M; Zeitoun, Jean-David; Krumholz, Harlan M; Ross, Joseph S

2017-05-09

Postmarket safety events of novel pharmaceuticals and biologics occur when new safety risks are identified after initial regulatory approval of these therapeutics. These safety events can change how novel therapeutics are used in clinical practice and inform patient and clinician decision making. To characterize the frequency of postmarket safety events among novel therapeutics approved by the US Food and Drug Administration (FDA), and to examine whether any novel therapeutic characteristics known at the time of FDA approval were associated with increased risk. Cohort study of all novel therapeutics approved by the FDA between January 1, 2001, and December 31, 2010, followed up through February 28, 2017. Novel therapeutic characteristics known at the time of FDA approval, including drug class, therapeutic area, priority review, accelerated approval, orphan status, near-regulatory deadline approval, and regulatory review time. A composite of (1) withdrawals due to safety concerns, (2) FDA issuance of incremental boxed warnings added in the postmarket period, and (3) FDA issuance of safety communications. From 2001 through 2010, the FDA approved 222 novel therapeutics (183 pharmaceuticals and 39 biologics). There were 123 new postmarket safety events (3 withdrawals, 61 boxed warnings, and 59 safety communications) during a median follow-up period of 11.7 years (interquartile range [IQR], 8.7-13.8 years), affecting 71 (32.0%) of the novel therapeutics. The median time from approval to first postmarket safety event was 4.2 years (IQR, 2.5-6.0 years), and the proportion of novel therapeutics affected by a postmarket safety event at 10 years was 30.8% (95% CI, 25.1%-37.5%). In multivariable analysis, postmarket safety events were statistically significantly more frequent among biologics (incidence rate ratio [IRR] = 1.93; 95% CI, 1.06-3.52; P = .03), therapeutics indicated for the treatment of psychiatric disease (IRR = 3.78; 95% CI, 1.77-8.06; P < .001), those receiving accelerated approval (IRR = 2.20; 95% CI, 1.15-4.21; P = .02), and those with near-regulatory deadline approval (IRR = 1.90; 95% CI, 1.19-3.05; P = .008); events were statistically significantly less frequent among those with regulatory review times less than 200 days (IRR = 0.46; 95% CI, 0.24-0.87; P = .02). Among 222 novel therapeutics approved by the FDA from 2001 through 2010, 32% were affected by a postmarket safety event. Biologics, psychiatric therapeutics, and accelerated and near-regulatory deadline approval were statistically significantly associated with higher rates of events, highlighting the need for continuous monitoring of the safety of novel therapeutics throughout their life cycle.

Regulatory administrative databases in FDA's Center for Biologics Evaluation and Research: convergence toward a unified database.

PubMed

Smith, Jeffrey K

2013-04-01

Regulatory administrative database systems within the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) are essential to supporting its core mission, as a regulatory agency. Such systems are used within FDA to manage information and processes surrounding the processing, review, and tracking of investigational and marketed product submissions. This is an area of increasing interest in the pharmaceutical industry and has been a topic at trade association conferences (Buckley 2012). Such databases in CBER are complex, not for the type or relevance of the data to any particular scientific discipline but because of the variety of regulatory submission types and processes the systems support using the data. Commonalities among different data domains of CBER's regulatory administrative databases are discussed. These commonalities have evolved enough to constitute real database convergence and provide a valuable asset for business process intelligence. Balancing review workload across staff, exploring areas of risk in review capacity, process improvement, and presenting a clear and comprehensive landscape of review obligations are just some of the opportunities of such intelligence. This convergence has been occurring in the presence of usual forces that tend to drive information technology (IT) systems development toward separate stovepipes and data silos. CBER has achieved a significant level of convergence through a gradual process, using a clear goal, agreed upon development practices, and transparency of database objects, rather than through a single, discrete project or IT vendor solution. This approach offers a path forward for FDA systems toward a unified database.

34 CFR 656.23 - What priorities may the Secretary establish?

Code of Federal Regulations, 2010 CFR

2010-07-01

... POSTSECONDARY EDUCATION, DEPARTMENT OF EDUCATION NATIONAL RESOURCE CENTERS PROGRAM FOR FOREIGN LANGUAGE AND AREA... priorities: (1) Specific countries or world areas, such as, for example, East Asia, Africa, or the Middle East. (2) Specific focus of a Center, such as, for example, a single world area; international studies...

78 FR 13600 - Proposed Priority-National Institute on Disability and Rehabilitation Research-Traumatic Brain...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-28

... designs. The research must focus on outcomes in one or more of the following domains identified in NIDRR's... Rehabilitation Research--Traumatic Brain Injury Model Systems Centers Collaborative Research Project [CFDA Number... Services proposes a priority under the Disability and Rehabilitation Research Projects and Centers Program...

Reducing the Number of Uninsured Children: Outreach and Enrollment Efforts. Testimony of Donna Cohen Ross, Center on Budget and Policy Priorities, before the Senate Finance Committee.

ERIC Educational Resources Information Center

Ross, Donna Cohen

This testimony of Donna Cohen Ross describes the Center on Budget and Policy Priorities' work to reduce the number of uninsured children. The Center specializes in programs and policies affecting low- and moderate-income families, including issues related to health coverage for the uninsured. It works with many groups on strategies to identify…

Pembrolizumab Secures FDA Approval in Stomach Cancer

MedlinePlus

... director of the Yale Cancer Center. Addressing the Biology of Stomach Cancer Patients with advanced gastric cancer ... drugs have been designed to address its specific biology. With the exception of ramucirumab, “there’s never been ...

FDA recognition of consensus standards in the premarket notification program.

PubMed

Marlowe, D E; Phillips, P J

1998-01-01

"The FDA has long advocated the use of standards as a significant contributor to safety and effectiveness of medical devices," Center for Devices and Radiological Health's (CDRH) Donald E. Marlowe and Philip J. Phillips note in the following article, highlighting the latest U.S. Food and Drug Administration (FDA) plans for use of standards. They note that the important role standards can play has been reinforced as part of FDA reengineering efforts undertaken in anticipation of an increased regulatory work-load and declining agency resources. As part of its restructuring effort, the FDA announced last spring that it would recognize some consensus standards for use in the device approval process. Under the new 510(k) paradigm--the FDA's proposal to streamline premarket review, which includes incorporating the use of standards in the review of 510(k) submissions--the FDA will accept proof of compliance with standards as evidence of device safety and effectiveness. Manufacturers may submit declarations of conformity to standards instead of following the traditional review process. The International Electrotechnical Commission (IEC) 60601 series of consensus standards, which deals with many safety issues common to electrical medical devices, was the first to be chosen for regulatory review. Other standards developed by nationally or internationally recognized standards development organizations, such as AAMI, may be eligible for use to ensure review requirements. In the following article, Marlowe and Phillips describe the FDA's plans to use standards in the device review process. The article focuses on the use of standards for medical device review, the development of the standards recognition process for reviewing devices, and the anticipated benefits of using standards to review devices. One important development has been the recent implementation of the FDA Modernization Act of 1997 (FDAMA), which advocates the use of standards in the device review process. In implementing the legislation, the FDA published in the Federal Register a list of standards to which manufacturers may declare conformity. Visit AAMI's Web site at www.aami.org/news/fda.standards for a copy of the list and for information on nominating other standards for official recognition by the agency. The FDA expects that use of standards will benefit the agency and manufacturers alike: "We estimate that in time, reliance on declarations of conformity to recognized standards could save the agency considerable resources while reducing the regulatory obstacles to entry to domestic and international markets," state the authors.

Regulatory concerns in the development of biologic-biomaterial combinations. United States Food and Drug Administration.

PubMed

Chapekar, M S

1996-01-01

Several biologic-biomaterial combinations are currently under development in an attempt to modulate tissue or organ function in patients. The FDA regulations on combination products and the intercenter agreements among the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Center for Drugs Evaluation and Research (CDER) provide further guidance on center jurisdiction of combination products and other products where there are jurisdictional concerns. The biological component of biologic-biomaterial combinations raises a number of issues that relate to the safety and bioactivity of the final product. For example, transmission of adventitious agents to patients via somatic cells, tissue, or cell-derived products is a major safety concern as are in vivo inflammatory responses elicited by the biomaterial component. CBER has drafted a number of "Points to Consider" documents to provide further guidance in the development of biological products. The intent of this article is to provide the highlights of the FDA regulations for combination products and the intercenter agreement between CBER and CDRH delineating the responsibilities of each center for medical device activities. In addition, the article focuses on the CBER's concerns related to the development of somatic cell-biomaterial combinations for therapeutic use.

78 FR 100 - Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-02

... Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research... CDRH and CBER and have been compiled into checklists for use by FDA review staff. In the Federal... do so by using the Internet. A search capability for all CDRH guidance documents is available at http...

76 FR 6476 - Town Hall Discussion With the Director of the Center for Devices and Radiological Health and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-04

... engage in a dialogue about issues of importance to FDA's Center for Devices and Radiological Health (CDRH...: I. Background In 2010, CDRH held three Town Hall meetings in Minneapolis, MN; Boston, MA; and Los... member of the public was invited to provide comments to or ask questions of CDRH participants. Due to the...

76 FR 13642 - Town Hall Discussion With the Director of the Center for Devices and Radiological Health and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-14

... dialogue about issues of importance to FDA's Center for Devices and Radiological Health (CDRH) and to... between 9 a.m. and 4 p.m., Monday through Friday. SUPPLEMENTARY INFORMATION: I. Background In 2010, CDRH... invited to provide comments to or ask questions of CDRH participants. We received positive feedback on...

Tobacco regulatory science: research to inform regulatory action at the Food and Drug Administration's Center for Tobacco Products.

PubMed

Ashley, David L; Backinger, Cathy L; van Bemmel, Dana M; Neveleff, Deborah J

2014-08-01

The U.S. Food and Drug Administration (FDA) promotes the development of regulatory science to ensure that a strong evidence base informs all of its regulatory activities related to the manufacture, marketing, and distribution of tobacco products as well as public education about tobacco product constituents and effects. Toward that end, the FDA's Center for Tobacco Products (CTP) provides funding for research studies with scientific aims that fall within its defined regulatory authority. However, given their traditional biomedical focus on basic and applied research, some researchers may not understand the principles of regulatory science or the types of studies CTP funds. The purpose of this paper is (1) to clarify the definition of regulatory science as a distinct scientific discipline, (2) to explore the role of tobacco regulatory science in order to help researchers understand the parameters and types of research that can be funded by CTP, and (3) to describe the types of research efforts that will inform the FDA's public health framework for tobacco product regulation. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco 2014. This work is written by (a) US Government employee(s) and is in the public domain in the US.

Quality assurance in nuclear medicine facilities; availability of final recommendations--FDA. Notice.

PubMed

1985-05-13

The Food and Drug Administration (FDA) is announcing the availability of final recommendations prepared by its Center for Devices and Radiological Health (CDRH) on quality assurance programs in nuclear medicine facilities. The final recommendations include the agency's rationale for the recommendations as well as references that can be used as well as references that can be used as guides in conducting quality control monitoring. These final recommendations are available as a technical report in CDRH's radiation recommendations series. They are intended to encourage and promote the development of voluntary quality assurance programs in nuclear medicine facilities.

Assessment of in vitro COPD models for tobacco regulatory science: Workshop proceedings, conclusions and paths forward for in vitro model use.

PubMed

Behrsing, Holger; Raabe, Hans; Manuppello, Joseph; Bombick, Betsy; Curren, Rodger; Sullivan, Kristie; Sethi, Sanjay; Phipps, Richard; Tesfaigzi, Yohannes; Yan, Sherwin; D'Ruiz, Carl; Tarran, Robert; Constant, Samuel; Phillips, Gary; Gaça, Marianna; Hayden, Patrick; Cao, Xuefei; Mathis, Carole; Hoeng, Julia; Braun, Armin; Hill, Erin

2016-05-01

The Family Smoking Prevention and Tobacco Control Act of 2009 established the Food and Drug Administration Center for Tobacco Products (FDA-CTP), and gave it regulatory authority over the marketing, manufacture and distribution of tobacco products, including those termed 'modified risk'. On 8-10 December 2014, IIVS organised a workshop conference, entitled Assessment of In Vitro COPD Models for Tobacco Regulatory Science, to bring together stakeholders representing regulatory agencies, academia, industry and animal protection, to address the research priorities articulated by the FDA-CTP. Specific topics were covered to assess the status of current in vitro technologies as they are applied to understanding the adverse pulmonary events resulting from tobacco product exposure, and in particular, the progression of chronic obstructive pulmonary disease (COPD). The four topics covered were: a) Inflammation and Oxidative Stress; b) Ciliary Dysfunction and Ion Transport; c) Goblet Cell Hyperplasia and Mucus Production; and d) Parenchymal/Bronchial Tissue Destruction and Remodelling. The 2.5 day workshop included 18 expert speakers, plus poster sessions, networking and breakout sessions, which identified key findings and provided recommendations to advance the in vitro technologies and assays used to evaluate tobacco-induced disease etiologies. The workshop summary was reported at the 2015 Society of Toxicology Annual Meeting, and the recommendations led to an IIVS-organised technical workshop in June 2015, entitled Goblet Cell Hyperplasia, Mucus Production, and Ciliary Beating Assays, to assess these assays and to conduct a proof-of-principle multi-laboratory exercise to determine their suitability for standardisation. Here, we report on the proceedings, recommendations and outcomes of the December 2014 workshop, including paths forward to continue the development of non-animal methods to evaluate tissue responses that model the disease processes that may lead to COPD, a major cause of mortality worldwide. 2016 FRAME.

Evaluation of efficacy of heartworm preventive products at the FDA.

PubMed

Hampshire, Victoria A

2005-10-24

The Center for Veterinary Medicine, U.S. Food and Drug Administration (FDA/CVM) has authority under the United States Code 21 under Section 514.80 to monitor for adverse experiences of approved animal products. Although veterinarians voluntarily report suspect drug-related events to manufacturers, firms that market FDA-approved animal products must report serious events to the FDA within 15 working days of the veterinarian or pet-owner's call to them. Under the present regulations, canine heartworm preventatives are approved for 100% efficacy after testing in laboratory and field conditions. The report of lack of efficacy against heartworm larvae is a serious adverse drug event because the resulting condition or the treatment of the condition is life threatening. Information on lack of effect that are deemed possibly, probably, or definitely drug-related available for review under generic product on the FDA/CVM website Surveillance of these reports indicates there are some failures for virtually all heartworm prevention product categories. Most failures have been reported in heartworm-endemic states. At this time, it is unclear whether these are representative of the rare occurrences of failure that have been in existence for a long time, but not reported regularly or promptly, or whether there is a true increase in complaints of ineffectiveness and real variability between products. This paper discusses methods, personnel, and procedures in place in the Division of Surveillance that will aid the FDA to better assess heartworm preventive treatment failures. It discusses scoring paradigms presently utilized by FDA/CVM to assess severity of complaints of lack of efficacy against heartworms, and welcomes audience input as to how to improve existing processes. Results suggest that more comprehensive reporting will provide FDA/CVM more accurate surveillance information regarding efficacy problems. Such practices will permit FDA/CVM to better interpret both incidence and severity of in-effect and possible patterns of emerging resistance and to convey this in any necessary updated labeling. It also indicates that as part of that process, practitioners should return to a more conservative testing schedule.

Building a roadmap to biomarker qualification: challenges and opportunities.

PubMed

Amur, Shashi G; Sanyal, Sarmistha; Chakravarty, Aloka G; Noone, Marianne H; Kaiser, James; McCune, Susan; Buckman-Garner, ShaAvhree Y

2015-01-01

The traditional route for regulatory acceptance of biomarkers in drug development is through submission of biomarker data in drug approval submissions in the context of a single drug development program. The US FDA's Critical Path Initiative called for establishment of a biomarker qualification process to enable progress in the drug development paradigm. In response to this, the Center for Drug Evaluation and Research (CDER) established a Biomarker Qualification Program (BQP) to qualify a biomarker for a specific context of use (COU). The qualified biomarker can then be used in multiple drug development programs for this COU without re-review. Here, we describe some of the features of the BQP and two new initiatives that have the potential to aid biomarker development through early interactions with the FDA. Finally, we discuss some of the feedback the FDA has received from submitters and the BQP's actions to strengthen the program.

Proposed method to calculate FRMAC intervention levels for the assessment of radiologically contaminated food and comparison of the proposed method to the U.S. FDA's method to calculate derived intervention levels

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kraus, Terrence D.; Hunt, Brian D.

This report reviews the method recommended by the U.S. Food and Drug Administration for calculating Derived Intervention Levels (DILs) and identifies potential improvements to the DIL calculation method to support more accurate ingestion pathway analyses and protective action decisions. Further, this report proposes an alternate method for use by the Federal Emergency Radiological Assessment Center (FRMAC) to calculate FRMAC Intervention Levels (FILs). The default approach of the FRMAC during an emergency response is to use the FDA recommended methods. However, FRMAC recommends implementing the FIL method because we believe it to be more technically accurate. FRMAC will only implement themore » FIL method when approved by the FDA representative on the Federal Advisory Team for Environment, Food, and Health.« less

Animal NARMS Surveillance Data

USDA-ARS?s Scientific Manuscript database

The National Antimicrobial Resistance Monitoring System (NARMS) is a collaborative program between the Food and Drug Administration (FDA), the Centers for Disease Control (CDC), and the United States Department of Agriculture to prospectively monitor changes in antimicrobial susceptibilities of zoon...

78 FR 25279 - Agency Information Collection Activities; Proposed Collection; Comment Request; Abbreviated New...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-30

... abbreviated new animal drug applications submitted to the Center for Veterinary Medicine, FDA. DATES: Submit....) Although over the last 5 fiscal years all sponsors chose to submit traditional ANADAs, some sponsors did...

Closing the information gap: informing better medical decisionmaking through the use of post-market safety and comparative effectiveness information.

PubMed

Fox, Bethany

2012-01-01

While FDA gathers vast amounts of data about prescription drugs prior to their marketing approval, important information about the relative effectiveness and long term safety of products is not required for approval, and often is never collected. Increased postmarket research on the safety and comparative effectiveness of products would improve medical decisionmaking and lead to better clinical outcomes. Fortunately, Congress has recognized the value of this information for healthcare professionals. In response to a congressional mandate in the FDA Amendments Act (FDAAA), FDA is developing the Sentinel Initiative, an active surveillance system for monitoring postmarket drug safety issues. FDAAA also authorized FDA to require a drug sponsor to conduct postmarket safety studies or clinical trials to address a specific safety concern. To increase the repository of comparative effectiveness information, Congress established the Patient-Centered Outcomes Research Institute (PCORI) in the Patient Protection and Affordable Care Act (PPACA), directing it to manage comparative effectiveness research (CER). This article discusses the need for better safety and comparative effectiveness information and outlines methods to efficiently conduct the research and communicate it effectively to healthcare professionals. Coordination between FDA and the PCORI in gathering and communicating postmarket information is recommended. Medical source data collected by the Sentinel Initiative should be used for CER in addition to postmarket safety surveillance, and FDA and the PCORI should adopt identical standards for the distribution and communication of CER. Coordination between the two entities is recommended to save costs, reduce duplication of efforts, and to generate and communicate more information on prescription drugs for medical decisionmakers.

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.

Improving the postmarket surveillance of total joint arthroplasty devices.

PubMed

Mahomed, Nizar N; Syed, Khalid; Sledge, Clement B; Brennan, Troyen A; Liang, Matthew H

2008-01-01

To evaluate the FDA's approval process and postmarket surveillance strategies for THR devices. The FDA Center for Devices and Radiological Health (CDRH) 510k releasable database was used to document approved THR devices. The CDRH Medical Device Reporting data files were used to study the efficiency of the FDA's post-market surveillance system. Manufacturers were contacted to supply information regarding their implants. Medline was searched between 1966-1996 to determine the percentage of THR devices with published data on clinical outcomes. Between 1976 and 1996, 701 new THR devices were approved by the Substantial Equivalent (SE) route and 34 were approved on the basis of Premarket Approval PMA. The number of approvals doubled between 1991-1995 compared to 1976-1990. Seventy-four different manufacturers obtained approval to market THR devices. Only four manufacturers obtained approval via the PMA application. Under Mandatory Device Reporting all revision arthroplasties should be reported. Using data from 2 independent services for which we had US hospital discharge data in 1993 we estimate that only 3% of all revision THR were reported to the FDA. Manufacturers of hip implants failed to provide useful information. Medline search revealed only 15% of the approved THR devices had published data on outcomes. Current FDA premarket approval and postmarket surveillance strategies fail to provide information for evidence-based selection of THR devices. Recommendations are made to avert problems with device failures.

Economics of new oncology drug development.

PubMed

DiMasi, Joseph A; Grabowski, Henry G

2007-01-10

Review existing studies and provide new results on the development, regulatory, and market aspects of new oncology drug development. We utilized data from the US Food and Drug Administration (FDA), company surveys, and publicly available commercial business intelligence databases on new oncology drugs approved in the United States and on investigational oncology drugs to estimate average development and regulatory approval times, clinical approval success rates, first-in-class status, and global market diffusion. We found that approved new oncology drugs to have a disproportionately high share of FDA priority review ratings, of orphan drug designations at approval, and of drugs that were granted inclusion in at least one of the FDA's expedited access programs. US regulatory approval times were shorter, on average, for oncology drugs (0.5 years), but US clinical development times were longer on average (1.5 years). Clinical approval success rates were similar for oncology and other drugs, but proportionately more of the oncology failures reached expensive late-stage clinical testing before being abandoned. In relation to other drugs, new oncology drug approvals were more often first-in-class and diffused more widely across important international markets. The market success of oncology drugs has induced a substantial amount of investment in oncology drug development in the last decade or so. However, given the great need for further progress, the extent to which efforts to develop new oncology drugs will grow depends on future public-sector investment in basic research, developments in translational medicine, and regulatory reforms that advance drug-development science.

Zika antiviral chemotherapy: identification of drugs and promising starting points for drug discovery from an FDA-approved library.

PubMed

Pascoalino, Bruno S; Courtemanche, Gilles; Cordeiro, Marli T; Gil, Laura H V G; Freitas-Junior, Lucio

2016-01-01

Background The recent epidemics of Zika virus (ZIKV) implicated it as the cause of serious and potentially lethal congenital conditions such microcephaly and other central nervous system defects, as well as the development of the Guillain-Barré syndrome in otherwise healthy patients. Recent findings showed that anti-Dengue antibodies are capable of amplifying ZIKV infection by a mechanism similar to antibody-dependent enhancement, increasing the severity of the disease. This scenario becomes potentially catastrophic when the global burden of Dengue and the advent of the newly approved anti-Dengue vaccines in the near future are taken into account. Thus, antiviral chemotherapy should be pursued as a priority strategy to control the spread of the virus and prevent the complications associated with Zika. Methods Here we describe a fast and reliable cell-based, high-content screening assay for discovery of anti-ZIKV compounds. This methodology has been used to screen the National Institute of Health Clinical Collection compound library, a small collection of FDA-approved drugs. Results and conclusion From 725 FDA-approved compounds triaged, 29 (4%) were found to have anti-Zika virus activity, of which 22 had confirmed (76% of confirmation) by dose-response curves. Five candidates presented selective activity against ZIKV infection and replication in a human cell line. These hits have abroad spectrum of chemotypes and therapeutic uses, offering valuable opportunities for selection of leads for antiviral drug discovery.

Risk-Based Aviation Security: Diffusion and Acceptance

DTIC Science & Technology

2012-03-01

Association ATR Automated Target Recognition BDO Behavior Detection Officer BIB Budget-In-Brief CBP Customs and Border Protection CDRH Center...Radiological Health ( CDRH ) (Cerra, 2006), the National Institute for Standards and Technology (NIST) (TSA, n.d. g), and the Johns Hopkins University Applied...safety related to AIT may have come from the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health ( CDRH ), the National

78 FR 46966 - Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-02

... the full cost recovery of FDA reinspection or recall oversight could impose severe economic hardship... Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM). Thus, as the starting...

76 FR 67196 - Approaches to Reducing Sodium Consumption; Establishment of Dockets; Request for Comments, Data...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-31

... FURTHER INFORMATION CONTACT: FDA: Richard E. Bonnette, Center for Food Safety and Applied Nutrition (HFS.... Xu, J, Kochanek, KD, Murphy, SL, Tejada-Vera, B. ``Deaths: preliminary data for 2007,'' CDC, National...

75 FR 2145 - Draft Guidance for Industry on Tobacco Health Document Submission; Availability; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-14

... section. This document corrects that error. FOR FURTHER INFORMATION CONTACT: May Nelson, Center for...-1717, May.Nelson@fda.hhs.gov . SUPPLEMENTARY INFORMATION: In FR Doc. E9-30657, appearing on page 68629...

78 FR 77687 - Science Advisory Board to the National Center for Toxicological Research; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-24

... advisory committee meeting link, or call the advisory committee information line to learn about possible... partner with FDA to foster the development of collaborative efforts in this area. To facilitate the...

Dealing with ADHD: What You Need to Know

MedlinePlus

... Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products For Consumers Home For Consumers Consumer Updates Dealing with ADHD: ... Academy of Child & Adolescent Psychiatry, ADHD Resource Center Consumer Updates on Children’s Health Research Flash: FDA Scientists ...

Prostate Cancer: Symptoms, Tests, and Treatment

MedlinePlus

... officer in FDA’s Office of Hematology and Oncology Products in the Center for Drug Evaluation and Research. Since docetaxel, FDA has approved five additional therapies, all of which have shown improvements in survival. In addition, several major trials showed ...

Preserving an Incentive for Global Health R&D: The Priority Review Voucher Secondary Market.

PubMed

Robertson, Andrew S

2016-05-01

In December 2014, the United States government expanded the Priority Review Voucher ("PRV" or "voucher") program to include Ebola and other related Filoviruses. By doing so, lawmakers provided a potentially powerful incentive for drug companies to invest time and money in the development of novel medicines for terrifying diseases. This expansion is one of several additions made to the PRV programs since 2012. Many companies rely on voucher resale to recoup research and development ("R&D") costs; however, it is unclear whether the PRV program could be overextended, thereby diluting the value of the incentives. In this paper, I use historical approval data from the Food and Drug Administration ("FDA") and United States drug revenue data to better understand the secondary market value of a PRV. The data suggests that that purchase prices of a PRV could continue to climb; despite this, the market size for these vouchers is limited. The implications of these findings are discussed further.

Introduction to tobacco control supplement.

PubMed

Chen, Ii-Lun; Husten, Corinne G

2014-05-01

Electronic cigarettes (e-cigarettes) have recently gained significant attention in the marketplace and in the media. However, limited information is available about the worldwide impact of e-cigarettes; most public health officials are calling for more data so they can more fully understand the potential risks and benefits of e-cigarettes in order to inform regulatory action. In the USA, e-cigarettes that are marketed as tobacco products are not currently regulated by the Food and Drug Administration (FDA). However, having a continuum of nicotine-containing products that cross jurisdictional lines within the FDA in the future would create the potential (and the need) for a comprehensive nicotine strategy at the FDA. As part of developing the most appropriate approach to e-cigarette regulation, FDA Center for Tobacco Products scientists have been reviewing the available literature to determine the state of e-cigarette knowledge and have identified research areas that could be addressed. This supplement provides a summary of the current knowledge and research gaps pertaining to e-cigarettes with regards to product design, chemistry and toxicology of e-liquid and aerosol constituents, human factor-based risk factors, abuse liability, clinical pharmacology and human health effects, paediatric issues, and environmental issues.

Biomarkers of Tobacco Exposure: Summary of an FDA-sponsored Public Workshop

PubMed Central

Chang, Cindy M.; Edwards, Selvin H.; Arab, Aarthi; Del Valle-Pinero, Arseima Y.; Yang, Ling; Hatsukami, Dorothy K.

2016-01-01

Since 2009, the United States (U.S.) Food and Drug Administration (FDA) Center for Tobacco Products (CTP) has had the authority to regulate the manufacturing, distribution, and marketing of tobacco products in order to reduce the death and disease caused by tobacco use. Biomarkers of exposure pertain to actual human exposure to chemicals arising from tobacco use and could play an important role across a number of FDA regulatory activities, including assessing new and modified risk tobacco products and identifying and evaluating potential product standards. On August 3–4, 2015, FDA/CTP hosted a public workshop focused on biomarkers of exposure with participants from government, industry, academia, and other organizations. The workshop was divided into four sessions focused on: 1) approaches to evaluating and selecting biomarkers; 2) biomarkers of exposure and relationship to disease risk; 3) currently-used biomarkers of exposure and biomarkers in development; and 4) biomarkers of exposure and the assessment of smokeless tobacco and electronic nicotine delivery systems (ENDS). This paper synthesizes the main findings from the workshop and highlights research areas that could further strengthen the science around biomarkers of exposure and help determine their application in tobacco product regulation. PMID:28151705

Show me the money! An analysis of underserved stakeholders' funding priorities in Patient Centered Outcomes Research domains.

PubMed

Cargill, Stephanie Solomon; Baker, Lauren Lyn; Goold, Susan Dorr

2017-07-01

Develop an accessible exercise to engage underserved populations about research funding priorities; analyze the criteria they use to prioritize research; contrast these criteria to those currently used by Patient Centered Outcomes Research Institute (PCORI). Academic and community partners collaborated to develop an Ipad exercise to facilitate group deliberation about PCOR funding priorities. 16 groups (n = 183) of underserved individuals in both urban and rural areas participated. Recordings were qualitatively analyzed for prioritization criteria. Analysis yielded ten codes, many of which were similar to PCORI criteria, but all of which challenged or illuminated these criteria. Directly involving underserved populations in determining funding criteria is both feasible and important, and can better fulfill PCORI's goal of incorporating patient priorities.

Critical Needs of Students Who Are Deaf or Hard of Hearing: A Public Input Summary

ERIC Educational Resources Information Center

Szymanski, Christen; Lutz, Lori; Shahan, Cheryl; Gala, Nicholas

2013-01-01

As mandated by the Education of the Deaf Act (EDA), the Clerc Center is required "to establish and publish priorities for research, development, and demonstration through a process that allows for public input." The public input summarized in this paper informed the Clerc Center's selection of its national priorities for 2013-2018: 1)…

Performing clinical studies involving hernia mesh devices: what every investigator should know about the FDA investigational device exemption (IDE) process.

PubMed

Ashar, B S; Dang, J M; Krause, D; Luke, M C

2011-12-01

The FDA's Center for Devices and Radiological Health (CDRH) is responsible for providing reasonable assurance of safety and effectiveness of all medical devices marketed within the US. To date, CDRH has cleared numerous hernia mesh devices for general use, but has not cleared/approved any mesh devices intended for certain specific uses, such as for infected wounds, hernia prevention, biofilm reduction, or prevention of adhesions. CDRH is requesting that manufacturers seeking specific hernia mesh device labeling claims consult with the Agency to determine the level of evidence necessary for justifying such claims.

Statistical innovations in the medical device world sparked by the FDA.

PubMed

Campbell, Gregory; Yue, Lilly Q

2016-01-01

The world of medical devices while highly diverse is extremely innovative, and this facilitates the adoption of innovative statistical techniques. Statisticians in the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) have provided leadership in implementing statistical innovations. The innovations discussed include: the incorporation of Bayesian methods in clinical trials, adaptive designs, the use and development of propensity score methodology in the design and analysis of non-randomized observational studies, the use of tipping-point analysis for missing data, techniques for diagnostic test evaluation, bridging studies for companion diagnostic tests, quantitative benefit-risk decisions, and patient preference studies.

Educating the Psychology Workforce in the Age of the Affordable Care Act: A Graduate Course Modeled after the Priorities of the Patient-Centered Outcomes Research Institute (PCORI)

PubMed Central

Hoerger, Michael

2015-01-01

The Affordable Care Act (ACA) represents a paradigm shift in the U.S. healthcare system, which has implications for psychology programs producing the next generation of trainees. In particular, the ACA has established the Patient-Centered Outcomes Research Institute (PCORI), which has been tasked with developing national priorities and funding research aimed at improving healthcare quality by helping patients and providers to make informed healthcare decisions. PCORI's national priorities span five broad domains: person-centered outcomes research, health disparities research, healthcare systems research, communication and dissemination research, and methodologic research. As these national priorities overlap with the knowledge and skills often emphasized in psychology training programs, initiatives by training programs to bolster strengths in these domains could place trainees at the forefront of this emerging research paradigm. As a part of a new Masters program in behavioral health, our program developed a health psychology course modeled around PCORI's five national priorities, and an initial evaluation in a small sample supported student learning in the five PCORI domains. In summary, the current report has implications for familiarizing readers with PCORI's national priorities for U.S. healthcare, stimulating debate surrounding psychology's response to the largest healthcare paradigm shift in recent U.S. history, and providing a working model for programs seeking to implement PCORI-related changes to their curricula. PMID:26843899

Delegations of authority and organization; Center for Devices and Radiological Health. Food and Drug Administration, HHS. Final rule.

PubMed

1999-02-02

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority to reflect redelegations to other officials within the Center for Devices and Radiological Health (CDRH) pertaining to: Certifying true copies and using the Department seal, disclosing official records, issuing reports of minor violations, and medical device reporting procedures. This amendment is intended to reflect those redelegations.

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. © 2014 Milbank Memorial Fund.

Genetic gatekeepers: regulating direct-to-consumer genomic services in an era of participatory medicine.

PubMed

Palmer, Jessica Elizabeth

2012-01-01

Should consumers be able to obtain information about their own bodies, even if it has no proven medical value? Direct-to-consumer ("DTC") genomic companies offer consumers two services: generation of the consumer's personal genetic sequence, and interpretation of that sequence in light of current research. Concerned that consumers will misunderstand genomic information and make ill-advised health decisions, regulators, legislators and scholars have advocated restricted access to DTC genomic services. The Food and Drug Administration, which has historically refrained from regulating most genetic tests, has announced its intent to treat DTC genomic services as medical devices because they make "medical claims." This Article argues that FDA regulation of genomic services as medical devices would be counterproductive. Clinical laboratories conducting genetic tests are already overseen by a federal regime administered by the Centers for Medicare and Medicaid Services. While consumers and clinicians would benefit from clearer communication of test results and their health implications, FDA's gatekeeping framework is ill-suited to weigh the safety and efficacy of genomic information that is not medically actionable in traditional ways. Playing gatekeeper would burden FDA's resources, conflict with the patient-empowering policies promoted by personalized medicine initiatives, impair individuals' access to information in which they have powerful autonomy interests, weaken novel participatory research infrastructures, and set a poor precedent for the future regulation of medical information. Rather than applying its risk-based regulatory framework to genetic information, FDA should ameliorate regulatory uncertainty by working with the Federal Trade Commission and Centers for Medicare and Medicaid Services to ensure that DTC genomic services deliver analytically valid data, market and implement their services in a truthful manner, and fully disclose the limitations of their services. Federal agencies with relevant expertise should collaborate on standards and best practices for interpreting genetic information in light of scientific uncertainty, and an adverse event reporting system should be established to collect empirical data verifying or disproving the speculative harms resulting from individual access to genetic information. Most of all, FDA should take advantage of this opportunity to adapt its regulatory process to an increasingly informational health ecosystem.

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 additional debacles similar to that of digital mammography where important technology has been withheld from millions of women for more than a decade. Copyright 2010 AUR. Published by Elsevier Inc. All rights reserved.

76 FR 7222 - Medical Device Innovation Initiative; Public Meeting; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-09

...] Medical Device Innovation Initiative; Public Meeting; Request for Comments AGENCY: Food and Drug... Administration (FDA) is announcing a public meeting entitled ``CDRH's Medical Device Innovation Initiative Public... Center for Devices and Radiological Health's (CDRH) document, ``Medical Device Innovation Initiative...

78 FR 67168 - Sixth Annual Sentinel Initiative; Public Workshop

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-08

...] Sixth Annual Sentinel Initiative; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION... workshop entitled ``Sixth Annual Sentinel Initiative.'' Convened by the Engelberg Center for Health Care... product surveillance. Topics will include an overview of the status of FDA's Sentinel Initiative and...

Navigating through the domains of biology and chemistry

EPA Science Inventory

Developing computational toxicology methods to assist the risk assessment process has recently gained much attention both in regulatory agencies and industries. The FDA Center for Food Safety and Applied Nutrition’s Office of Food Additive Safety (CFSAN OFAS) uses (Q)SAR approach...

Delphi Technique Used in Laser Incident Surveillance

DTIC Science & Technology

2004-01-01

Registry (LAIR), and the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health ( CDRH ) [10]. Other databases were consulted...for collecting laser incident reports such as training (RLI), reporting equipment problems ( CDRH ), or for research and accident prevention (LAIR

48 CFR 301.270 - Executive Committee for Acquisition.

Code of Federal Regulations, 2011 CFR

2011-10-01

...). (10) Program Support Center (PSC). (11) Substance Abuse and Mental Health Services Administration... Acquisition. 301.270 Section 301.270 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES GENERAL... Medicare and Medicaid Services (CMS). (6) Food and Drug Administration (FDA). (7) Health Resources and...

48 CFR 301.270 - Executive Committee for Acquisition.

Code of Federal Regulations, 2010 CFR

2010-10-01

...). (10) Program Support Center (PSC). (11) Substance Abuse and Mental Health Services Administration... Acquisition. 301.270 Section 301.270 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES GENERAL... Medicare and Medicaid Services (CMS). (6) Food and Drug Administration (FDA). (7) Health Resources and...

76 FR 5380 - Advisory Committees; Filing of Closed Meeting Reports

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-31

... for Biologics Evaluation and Research: Blood Products Advisory Committee, Vaccines and Related Biological Products Advisory Committee. National Center for Toxicological Research: Science Board to the... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA 2011-N-0002...

Awareness and trust of the FDA and CDC: Results from a national sample of US adults and adolescents

PubMed Central

2017-01-01

Trust in government agencies plays a key role in advancing these organizations' agendas, influencing behaviors, and effectively implementing policies. However, few studies have examined the extent to which individuals are aware of and trust the leading United States agencies devoted to protecting the public’s health. Using two national samples of adolescents (N = 1,125) and adults (N = 5,014), we examined demographic factors, with a focus on vulnerable groups, as correlates of awareness of and trust in the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and the federal government. From nine different weighted and adjusted logistic regression models, we found high levels of awareness of the existence of the FDA and CDC (ranging from 55.7% for adolescents’ awareness of the CDC to 94.3% for adults’ awareness of the FDA) and moderate levels of trust (ranging from a low of 41.8% for adults’ trust in the federal government and a high of 78.8% for adolescents’ trust of the FDA). In the adolescent and adult samples, awareness was higher among non-Hispanic Blacks and respondents with low numeracy. With respect to trust, few consistent demographic differences emerged. Our findings provide novel insights regarding awareness and trust in the federal government and specific United States public health agencies. Our findings suggest groups to whom these agencies may want to selectively communicate to enhance trust and thus facilitate their communication and regulatory agendas. PMID:28520750

Awareness and trust of the FDA and CDC: Results from a national sample of US adults and adolescents.

PubMed

Kowitt, Sarah D; Schmidt, Allison M; Hannan, Anika; Goldstein, Adam O

2017-01-01

Trust in government agencies plays a key role in advancing these organizations' agendas, influencing behaviors, and effectively implementing policies. However, few studies have examined the extent to which individuals are aware of and trust the leading United States agencies devoted to protecting the public's health. Using two national samples of adolescents (N = 1,125) and adults (N = 5,014), we examined demographic factors, with a focus on vulnerable groups, as correlates of awareness of and trust in the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and the federal government. From nine different weighted and adjusted logistic regression models, we found high levels of awareness of the existence of the FDA and CDC (ranging from 55.7% for adolescents' awareness of the CDC to 94.3% for adults' awareness of the FDA) and moderate levels of trust (ranging from a low of 41.8% for adults' trust in the federal government and a high of 78.8% for adolescents' trust of the FDA). In the adolescent and adult samples, awareness was higher among non-Hispanic Blacks and respondents with low numeracy. With respect to trust, few consistent demographic differences emerged. Our findings provide novel insights regarding awareness and trust in the federal government and specific United States public health agencies. Our findings suggest groups to whom these agencies may want to selectively communicate to enhance trust and thus facilitate their communication and regulatory agendas.

Profiles of Choice: Parents' Patterns of Priority in Child Care Decision-Making

ERIC Educational Resources Information Center

Kim, Jinseok; Fram, Maryah Stella

2009-01-01

Responding adequately to parental priorities for child care is important for shaping children's early experiences and development, and for facilitating parenting at the nexus of work and caregiving roles. Although much research on child care choice has relied on variable-centered approaches that treat parental priorities as distinct and isolated,…

Statistical, epidemiological, and risk-assessment approaches to evaluating safety of vaccines throughout the life cycle at the Food and Drug Administration.

PubMed

Ball, Robert; Horne, Dale; Izurieta, Hector; Sutherland, Andrea; Walderhaug, Mark; Hsu, Henry

2011-05-01

The public health community faces increasing demands for improving vaccine safety while simultaneously increasing the number of vaccines available to prevent infectious diseases. The passage of the US Food and Drug Administration (FDA) Amendment Act of 2007 formalized the concept of life-cycle management of the risks and benefits of vaccines, from early clinical development through many years of use in large numbers of people. Harnessing scientific and technologic advances is necessary to improve vaccine-safety evaluation. The Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research is working to improve the FDA's ability to monitor vaccine safety by improving statistical, epidemiologic, and risk-assessment methods, gaining access to new sources of data, and exploring the use of genomics data. In this article we describe the current approaches, new resources, and future directions that the FDA is taking to improve the evaluation of vaccine safety.

75 FR 76018 - Third Annual Sentinel Initiative Public Workshop

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-07

...] Third Annual Sentinel Initiative Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION... workshop: Third Annual Sentinel Initiative Public Workshop. Hosted by the Engelberg Center for Health Care..., including an update on Mini-Sentinel and related activities, near-term plans for FDA's Sentinel Initiative...

21 CFR 314.445 - Guidance documents.

Code of Federal Regulations, 2010 CFR

2010-04-01

... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Miscellaneous Provisions § 314.445 Guidance... directed to the Office of Training and Communications, Division of Drug Information, Center for Drug...

Hand Sanitizers Carry Unproven Claims to Prevent MRSA Infections

MedlinePlus

... misled if they think these products you can buy in a drug store or from other places will protect them ... Deborah Autor, compliance director at FDA's Center for Drug Evaluation and ... claims, too—whether they buy a product from a retail store or through ...

Clinical trials of boron neutron capture therapy [in humans] [at Beth Israel Deaconess Medical Center][at Brookhaven National Laboratory

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wallace, Christine

2001-05-29

Assessment of research records of Boron Neutron Capture Therapy was conducted at Brookhaven National Laboratory and Beth Israel Deaconess Medical Center using the Code of Federal Regulations, FDA Regulations and Good Clinical Practice Guidelines. Clinical data were collected from subjects' research charts, and differences in conduct of studies at both centers were examined. Records maintained at Brookhaven National Laboratory were not in compliance with regulatory standards. Beth Israel's records followed federal regulations. Deficiencies discovered at both sites are discussed in the reports.

Direct-to-consumer advertising for bleeding disorders: a content analysis and expert evaluation of advertising claims.

PubMed

Abel, G A; Neufeld, E J; Sorel, M; Weeks, J C

2008-10-01

In the United States, the Food and Drug Administration (FDA) requires that all direct-to-consumer advertising (DTCA) contain both an accurate statement of a medication's effects ('truth') and an even-handed discussion of its benefits and risks/adverse effects ('fair balance'). DTCA for medications to treat rare diseases such as bleeding disorders is unlikely to be given high priority for FDA review. We reviewed all DTCA for bleeding disorder products appearing in the patient-directed magazine HemeAware from January 2004 to June 2006. We categorized the information presented in each advertisement as benefit, risk/adverse effect, or neither, and assessed the amount of text and type size devoted to each. We also assessed the readability of each type of text using the Flesch Reading Ease Score (FRES, where a score of >or=65 is considered of average readability), and assessed the accuracy of the advertising claims utilizing a panel of five bleeding disorder experts. A total of 39 unique advertisements for 12 products were found. On average, approximately twice the amount of text was devoted to benefits as compared with risks/adverse effects, and the latter was more difficult to read [FRES of 32.0 for benefits vs. 20.5 for risks/adverse effects, a difference of 11.5 (95% CI: 4.5-18.5)]. Only about two-thirds of the advertising claims were considered by a majority of the experts to be based on at least low-quality evidence. As measured by our methods, print DTCA for bleeding disorders may not reach the FDA's standards of truth and fair balance.

Biosimilars in psoriasis: what can we expect?

PubMed

Radtke, Marc Alexander; Augustin, Matthias

2014-04-01

Biosimilars are biotechnologically processed drugs whose amino acid sequence is identical to the original biopharmaceutical. They are of considerable clinical, economical, and health care interest. As patents for biologicals used to treat psoriasis expire, biosimilars will become more and more important within the field of dermatology. The patents for the two top-selling drugs (adalimumab and etanercept) will terminate in the next few years. Applications for biosimilars will presumably be submitted to the EMA and the FDA for all patent-free biologicals. Both regulatory bodies have issued guidelines on the assessment of bioequivalence, as well as the benefits and risks of biosimilars. While the preclinical requirements of the FDA and EMA are largely comparable, the formal requirements for clinical bioequivalence, including clinical efficacy and safety, differ markedly. Therefore, from a medical and health care perspective before biosimilars enter the market, specific evidence-based regulatory conditions need to be created and fulfilled. Only then biosimilars can be a less expensive option for a large number of patients, providing them with substances of the same value. Adequate, unequivocal proof of their bioequivalence, quality, and related patient safety should have priority over any ostensible economic benefits. © 2014 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd.

77 FR 48131 - Environmental Management Site-Specific Advisory Board, Hanford

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-13

...: Red Lion Hotel, 1101 North Columbia Center Boulevard, Kennewick, WA 99336. FOR FURTHER INFORMATION... Priorities and HAB Work Plan Priorities 2013 HAB Meeting Calendar Board Business [cir] HAB Budget [cir...

Establishment of a public docket for medical device/radiological health policy statements and operating procedure guides--FDA. Notice.

PubMed

1993-07-27

The Food and Drug Administration (FDA) is announcing that it is establishing a public docket for policy speeches, policy statements, and standard operating procedure guides pertaining to product evaluation and regulatory enforcement for its medical device and radiological health programs. The docket will operate on a 1-year trial basis and will serve both as a repository for critical policy documents generated by the Center for Devices and Radiological Health (CDRH) and as a public display mechanism for access by representatives of the industry and other interested persons. This action is one element of an overall communications initiative to ensure uniform and timely access to important information.

77 FR 76049 - Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-26

..., Office of Planning & Informatics, Center for Drug Evaluation and Research, Food and Drug Administration... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0643...: Food and Drug Administration, HHS. ACTION: Notice; correction. [[Page 76050

78 FR 37228 - Cooperative Agreement To Support the Western Center for Food Safety

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-20

... Davis main campus and experimental stations provide invaluable access to one of the leading food... sites for experimental trials is instrumental to FDA receiving the most current scientifically validated... facilitate industry compliance with preventive control standards. Information gleaned from this research has...

77 FR 3780 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-25

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. The...

21 CFR 803.11 - What form should I use to submit reports of individual adverse events and where do I obtain these...

Code of Federal Regulations, 2010 CFR

2010-04-01

..., Office of Communication, Education, and Radiation Programs, Center for Devices and Radiological Health...-3151; (d) On the Internet at http://www.fda.gov/medwatch/getforms.htm. [72 FR 17399, Apr. 9, 2007] ...

Center for Research Strategy Priority Initiatives

Cancer.gov

CRS leads priority initiatives to support cancer research to advance scientific knowledge and help people live longer, healthier lives. Learn more about the Resources for Cancer Researchers portal, Team Science, and Idea Generation with NCI staff.

34 CFR 366.13 - How does the Secretary determine funding priorities?

Code of Federal Regulations, 2010 CFR

2010-07-01

... LIVING Training and Technical Assistance § 366.13 How does the Secretary determine funding priorities? In... training and technical assistance needs identified by the survey of SILCs and centers required by section...

Compounding pharmacy conundrum: "we cannot live without them but we cannot live with them" according to the present paradigm.

PubMed

Guharoy, Roy; Noviasky, John; Haydar, Ziad; Fakih, Mohamad G; Hartman, Christian

2013-04-01

Compounding pharmacies serve a critical role in modern health care to meet special patient care needs. Although the US Food and Drug Administration (FDA) has clearly delineated jurisdiction over drug companies and products manufactured under Good Manufacturing Practice (GMP) regulations to ensure quality, potency, and purity, compounding pharmacies are regulated by the State Boards and are not registered by the FDA. In recent years, some compounding pharmacies acted like a manufacturer, preparing large amounts of injectable drugs with interstate activities. Multiple outbreaks have been linked to compounding pharmacies, including a recent outbreak of fungal meningitis related to contaminated methylprednisolone, exposing > 14,000 patients in multiple states. This tragedy underscores the urgency of addressing safety related to compounding pharmacies. There is a call for action at the federal and state levels to set minimum production standards, impose new labeling conditions on compounded drugs, and require large-scale compounders be regulated by the FDA. "Industrial" compounding must come under FDA oversight, require those pharmacies to meet GMP standards, and ensure quality and safe products for patient use. Moreover, compliance with the Institute for Safe Medication Practices 2011 recommendations that any type of sterile compounding must be in compliance with the United States Pharmacopoeia chapter 797 guidelines will reduce the risk of patient harm from microbial contamination. Finally, other critical factors that require close attention include addressing injectable products compounded in hospitals and other outpatient health-care centers. The FDA and State Boards of Pharmacy must be adequately funded to exercise the oversight effectively.

Eliciting Values of Patients with Multiple Chronic Conditions: Evaluation of a Patient-centered Framework

PubMed Central

Berry, Andrew B.L.; Lim, Catherine; Hartzler, Andrea L.; Hirsch, Tad; Ludman, Evette; Wagner, Edward H.; Ralston, James D.

2017-01-01

Patients with multiple chronic conditions often face competing demands for care, and they often do not agree with physicians on priorities for care. Patients ’ values shape their healthcare priorities, but existing methods for eliciting values do not necessarily meet patients ’ care planning needs. We developed a patient-centered values framework based on a field study with patients and caregivers. In this paper we report on a survey to evaluate how the framework generalizes beyond field study participants, and how well the framework supports values elicitation. We found that respondents frame values in a way that is consistent with the framework, and that domains of the framework can be used to elicit a breadth of potential values individuals with MCC express. These findings demonstrate how a patient-centered perspective on values can expand on the domains considered in values clarification methods andfacilitate patient-provider communication in establishing shared care priorities. PMID:29854107

Eliciting Values of Patients with Multiple Chronic Conditions: Evaluation of a Patient-centered Framework.

PubMed

Berry, Andrew B L; Lim, Catherine; Hartzler, Andrea L; Hirsch, Tad; Ludman, Evette; Wagner, Edward H; Ralston, James D

2017-01-01

Patients with multiple chronic conditions often face competing demands for care, and they often do not agree with physicians on priorities for care. Patients ' values shape their healthcare priorities, but existing methods for eliciting values do not necessarily meet patients ' care planning needs. We developed a patient-centered values framework based on a field study with patients and caregivers. In this paper we report on a survey to evaluate how the framework generalizes beyond field study participants, and how well the framework supports values elicitation. We found that respondents frame values in a way that is consistent with the framework, and that domains of the framework can be used to elicit a breadth of potential values individuals with MCC express. These findings demonstrate how a patient-centered perspective on values can expand on the domains considered in values clarification methods andfacilitate patient-provider communication in establishing shared care priorities.

76 FR 19996 - Cooperative Agreement With the University of Mississippi's National Center for Natural Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-11

..., non- governmental organizations, and international organizations and other activities on which the FDA... botanical ingredients from: (1) The faculty in the UM School of Pharmacy, including researchers in the... with the dietary supplement industry; and (5) established formal agreements with several international...

Honest broker protocol streamlines research access to data while safeguarding patient privacy.

PubMed

Silvey, Scott A; Silvey, Scott Andrew; Schulte, Janet; Smaltz, Detlev H; Smaltz, Detlev Herb; Kamal, Jyoti

2008-11-06

At Ohio State University Medical Center, The Honest Broker Protocol provides a streamlined mechanism whereby investigators can obtain de-identified clinical data for non-FDA research without having to invest the significant time and effort necessary to craft a formalized protocol for IRB approval.

77 FR 59624 - Gastrointestinal Drugs Advisory Committee; Notice of Postponement of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-28

... FURTHER INFORMATION CONTACT: Cindy Hong, Center for Drug Evaluation and Research, Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Gastrointestinal Drugs Advisory Committee; Notice of Postponement of Meeting AGENCY: Food and Drug Administration...

77 FR 29667 - Blood Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-18

...] Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Blood... Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review, Center for Biologics...

78 FR 38351 - Blood Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-26

...] Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Blood... Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review, Center for Biologics...

Cephalosporin Resistance among Non-Typhi Salmonella from Humans, Retail Meats and Food Animals in the United States

USDA-ARS?s Scientific Manuscript database

Background: The National Antimicrobial Resistance Monitoring System (NARMS) is a collaboration among the Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), and the Centers for Disease Control and Prevention (CDC). Here we report on decreased susceptibility to cephalosporins ...

21 CFR 312.145 - Guidance documents.

Code of Federal Regulations, 2014 CFR

2014-04-01

... HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION Miscellaneous § 312.145 Guidance documents. (a) FDA has... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. A request for a copy of the CBER list should be directed to...

21 CFR 312.145 - Guidance documents.

Code of Federal Regulations, 2013 CFR

2013-04-01

... HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION Miscellaneous § 312.145 Guidance documents. (a) FDA has... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. A request for a copy of the CBER list should be directed to...

21 CFR 312.145 - Guidance documents.

Code of Federal Regulations, 2012 CFR

2012-04-01

... HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION Miscellaneous § 312.145 Guidance documents. (a) FDA has... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. A request for a copy of the CBER list should be directed to...

21 CFR 312.145 - Guidance documents.

Code of Federal Regulations, 2011 CFR

2011-04-01

... HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION Miscellaneous § 312.145 Guidance documents. (a) FDA has... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. A request for a copy of the CBER list should be directed to...

78 FR 49528 - Consolidation of Wound Care Products Containing Live Cells

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-14

...] Consolidation of Wound Care Products Containing Live Cells AGENCY: Food and Drug Administration, HHS. ACTION... certain wound care products containing live cells from the Center for Devices and Radiological Health... CDRH and CBER. FDA believes that as more wound care products containing live cells are developed such...

75 FR 52605 - Veterinary Medicine Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-26

...] Veterinary Medicine Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). The meeting will be open to the public. Name of Committee: Veterinary Medicine Advisory..., Rockville, MD 20852, 301-468-1100. Contact Person: Aleta Sindelar, Center for Veterinary Medicine (HFV-3...

Epidemiology, ecology, and molecular genetics of antimicrobial resistance in pathogenic and commensal bacteria from food animals

USDA-ARS?s Scientific Manuscript database

The National Antimicrobial Resistance Monitoring System (NARMS) is a collaborative program between the Food and Drug Administration (FDA), the Centers for Disease Control (CDC), and the United States Department of Agriculture to prospectively monitor changes in antimicrobial susceptibilities of zoon...

75 FR 65640 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-26

...] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug... closed to the public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee. General... Branch, Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, FDA...

78 FR 28851 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0519] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How To Submit Information in Electronic Format to Center for Veterinary Medicine Using the Food and...

78 FR 53772 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0519... Veterinary Medicine Using the Food and Drug Administration Electronic Submission Gateway AGENCY: Food and... Center for Veterinary Medicine (CVM) accepts certain types of submissions electronically with no...

77 FR 33223 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-05

... preparedness activities, FDA's Center for Devices and Radiological Health (CDRH) began developing operational plans and interventions that would enable CDRH to anticipate and respond to medical device shortages... particular, CDRH identified the need to acquire and maintain detailed data on domestic inventory...

75 FR 66103 - Agency Information Collection Activities; Proposed Collection; Comment Request; Application for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-27

...'s Center for Devices and Radiological Health (CDRH) to easily and efficiently elicit and review information from students and health care professionals who are interested in becoming involved in CDRH... expertise with CDRH. FDA estimates the burden of this collection of information as follows: Table 1...

76 FR 18558 - Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception From...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-04

... Sponsors: Exception From Informed Consent for Emergency Research; Availability AGENCY: Food and Drug... oversight of research involving FDA-regulated products (e.g., drugs, biological products, devices) in..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51...

76 FR 52334 - Arthritis Advisory Committee; Notice of Postponement of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-22

...: Philip A. Bautista, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Arthritis Advisory Committee; Notice of Postponement of Meeting AGENCY: Food and Drug Administration, HHS...

78 FR 42088 - Anesthetic and Analgesic Drug Products Advisory Committee; Cancellation

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-15

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Anesthetic and Analgesic Drug Products Advisory Committee; Cancellation AGENCY: Food and Drug Administration..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31...

77 FR 41415 - Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-13

... INFORMATION CONTACT: Astrid Lopez-Goldberg, Center for Drug Evaluation and Research, Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0563] Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration and...

78 FR 44484 - Menthol in Cigarettes, Tobacco Products; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-24

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1140 [Docket No. FDA-2013-N-0521] Menthol in Cigarettes, Tobacco Products; Request for Comments AGENCY: Food and Drug... CONTACT: Annette L. Marthaler, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate...

75 FR 10808 - CIBA Vision Corp.; Withdrawal of Color Additive Petitions

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-09

...) CIBA Vision Corp.; Withdrawal of Color Additive Petitions AGENCY: Food and Drug Administration, HHS... Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition. [FR Doc. 2010-4972... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2005-C-0245...

TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.« less

US definitions, current use, and FDA stance on use of platelet-rich plasma in sports medicine.

PubMed

Beitzel, Knut; Allen, Donald; Apostolakos, John; Russell, Ryan P; McCarthy, Mary Beth; Gallo, Gregory J; Cote, Mark P; Mazzocca, Augustus D

2015-02-01

With increased utilization of platelet-rich plasma (PRP), it is important for clinicians to understand the United States, the Food and Drug Administration (FDA) regulatory role and stance on PRP. Blood products such as PRP fall under the prevue of FDA's Center for Biologics Evaluation and Research (CBER). CBER is responsible for regulating human cells, tissues, and cellular and tissue-based products. The regulatory process for these products is described in the FDA's 21 CFR 1271 of the Code of Regulations. Under these regulations, certain products including blood products such as PRP are exempt and therefore do not follow the FDA's traditional regulatory pathway that includes animal studies and clinical trials. The 510(k) application is the pathway used to bring PRP preparation systems to the market. The 510(k) application allows devices that are "substantially equivalent" to a currently marketed device to come to the market. There are numerous PRP preparation systems on the market today with FDA clearance; however, nearly all of these systems have 510(k) clearance for producing platelet-rich preparations intended to be used to mix with bone graft materials to enhance bone graft handling properties in orthopedic practices. The use of PRP outside this setting, for example, an office injection, would be considered "off label." Clinicians are free to use a product off-label as long as certain responsibilities are met. Per CBER, when the intent is the practice of medicine, clinicians "have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects." Finally, despite PRP being exempted, the language in 21 CFR 1271 has caused some recent concern over activated PRP; however to date, the FDA has not attempted to regulate activated PRP. Clinicians using activated PRP should be mindful of these concerns and continued to stay informed. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Marketing approval for the lithotripter.

PubMed

Nightingale, S L; Young, F E

1986-01-01

In December 1984, the Food and Drug Administration (FDA) granted Dornier Systems (FRG) approval to market the external shock wave lithotripter (ESWL) in the USA. The Medical Device Amendments of the Food, Drug, and Cosmetic Act require that the FDA evaluate the safety and effectiveness of medical devices intended for commercial distribution in the U.S. Such evaluation includes basic scientific studies, animal testing, and investigational studies in human subjects, culminating in a judgment concerning acceptable risks in terms of anticipated benefits, and whether the device is effective for its intended use. Prior to human studies in West Germany, Dornier had evaluated the destruction of stones of varying composition, measured the rate and energy of stone destruction, and tested blood samples and lymphocyte cultures exposed to shock waves. In addition, studies in both rats and dogs had demonstrated the feasibility of the technique and evidence of safety. Such data are provided by manufacturers when applying for an investigational device exemption (IDE) from the FDA, which permits clinical studies in humans; such studies also require the approval of an Institutional Review Board. The FDA approved Dornier's IDE, allowing human investigational use of the ESWL in facilities in the U.S., conducted concurrently with similar studies in West Germany. Upon completion of clinical trials, data acquired in vitro, in laboratory animals, and in human investigations are submitted to the FDA for a premarked approval application (PMAA). The Agency was given 6 months to make a decision, taking into consideration the recommendation of an advisory panel of experts from outside the Agency who had reviewed the same data. In its evaluation of the ESWL for safety and effectiveness, the FDA considered the question of alternative practices and procedures to treat nephrolithiasis, including percutaneous nephrolithotomy and open surgical procedures, and the adverse effects of such procedures. Clinical data available at the time of review for approval included reports of treatment of 667 patients in West German centers, and 327 patients treated in three U.S. facilities. Dornier and the FDA initiated discussions concerning the labeling of the device and a postmarketing surveillance plan. These were completed and marketing approval for the ESWL was granted.

TU-AB-204-04: Partnerships

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ochs, R.

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.« less

FDA use of international standards in the premarket review process.

PubMed

Rechen, E; Barth, D J; Marlowe, D; Kroger, L

1998-01-01

"This is an exciting time," says Eric Rechen, policy analyst in the U.S. Food and Drug Administration's (FDA) Office of Device Evaluation (ODE). "We're entering an era in which standards will have a more prominent role in the review of medical devices than ever before." During the past 10 years, there has been significant growth in the importance of standards in regulatory processes, as Donald J. Barth, regulatory staff manager for the Medical Products Group at Hewlett Packard Company, notes in setting the stage for discussion of the latest developments. Donald Marlowe, director of the FDA's Office of Science and Technology, and Rechen explain the use of standards in the regulatory review process as part of FDA efforts to ensure public safety in a time of shrinking agency resources. Marlowe discusses provisions of the FDA Modernization Act of 1997 that allow manufacturers to submit a declaration of conformity to a standard to satisfy premarket review requirements. A guidance on the recognition and use of consensus standards, a list of recognized standards, and a list of frequently asked questions are available at the Web site of the Center for Devices and Radiological Health (CDRH) at www.fda.gov/cdrh and via the AAMI Web site at www.aami.org. The information is also available by telephone via CDRH Facts on Demand at 800-899-0381. Rechen provides details about the two new approaches for premarket notifications available under the new 510(k) paradigm. Manufacturers may demonstrate substantial equivalence through special and abbreviated 510(k)s in addition to traditional 510(k)s. A copy of the new 510(k) paradigm is available at the AAMI and CDRH Web sites and through Facts on Demand. As the FDA and many manufacturers enter the new world of abbreviated and special 510(k)s, Larry Kroger, GE Medical Systems, provides his comments based on the 4 years of experience manufacturers of diagnostic x-ray products have had with simplified 510(k)s. A comparison of the European conformity assessment procedures with the new 510(k) paradigm will appear in an upcoming issue of BI&T.

Recruiting Healthy Volunteers for Research Participation via Internet Advertising

PubMed Central

Bramstedt, Katrina A.

2007-01-01

Objective: The Internet is frequently used as a tool to recruit research subjects, and the US Food and Drug Administration (FDA) provides general guidance regarding such advertising. The goal of this study was to explore the incidence and nature of ethically inappropriate recruiting advertisements on the Internet and to provide descriptive guidance to researchers for responsible Internet recruiting. Methods: In this study, 119 advertisements recruiting health volunteers and listed on the CenterWatch Clinical Trials Listing Service website were reviewed for content as well as text style and visual effects. Results: The majority of advertisements satisfied FDA guidance. However, 21 (18%) were ethically troubling with regard to font size, font style, and/or verbiage. In many advertisements, it was unclear if “medication” meant “investigational drug,” “over-the-counter medication” or US FDA approved “prescription medication.” Nearly 30% of the 119 advertisements used the terms “free,” “no charge” or “no cost” as lures. Conclusion: Ethically problematic recruiting advertisements can be coercive and misleading. Descriptive guidance provided in this paper can help clinical researchers create ethically appropriate recruiting advertisements. PMID:17607043

Active surveillance of postmarket medical product safety in the Federal Partners' Collaboration.

PubMed

Robb, Melissa A; Racoosin, Judith A; Worrall, Chris; Chapman, Summer; Coster, Trinka; Cunningham, Francesca E

2012-11-01

After half a century of monitoring voluntary reports of medical product adverse events, the Food and Drug Administration (FDA) has launched a long-term project to build an adverse events monitoring system, the Sentinel System, which can access and evaluate electronic health care data to help monitor the safety of regulated medical products once they are marketed. On the basis of experience gathered through a number of collaborative efforts, the Federal Partners' Collaboration pilot project, involving FDA, the Centers for Medicare & Medicaid Services, the Department of Veteran Affairs, and the Department of Defense, is already enabling FDA to leverage the power of large public health care databases to assess, in near real time, the utility of analytical tools and methodologies that are being developed for use in the Sentinel System. Active medical product safety surveillance is enhanced by use of these large public health databases because specific populations of exposed patients can be identified and analyzed, and can be further stratified by key variables such as age, sex, race, socioeconomic status, and basis for eligibility to examine important subgroups.

Analysis of Drug Development Paradigms for Immune Checkpoint Inhibitors.

PubMed

Jardim, Denis L; de Melo Gagliato, Débora; Giles, Francis J; Kurzrock, Razelle

2018-04-15

Immune checkpoint inhibitors have unique toxicities and response kinetics compared with cytotoxic and gene-targeted anticancer agents. We investigated the impact of innovative/accelerated immunotherapy drug development/approval models on the accuracy of safety and efficacy assessments by searching the FDA website. Initial phase I trials for each agent were reviewed and safety and efficacy data compared with that found in later trials leading to regulatory approvals of the same agents. As of June 2017, the FDA approved six checkpoint inhibitors for a variety of cancer types. All checkpoint inhibitors received a priority review status and access to at least two additional FDA special access programs, more often breakthrough therapy designation and accelerated approval. Median clinical development time (investigational new drug application to approval) was 60.77 months [avelumab had the shortest timeline (52.33 months)]. Response rates during early phase I trials (median = 16%) are higher than for phase I trials of other agents (with the exception of gene-targeted agents tested with a biomarker). Doses approved were usually not identical to doses recommended on phase I trials. Approximately 50% of types of immune-related and 43% of types of clinically relevant toxicities from later trials were identified in early-phase trials. Even so, treatment-related mortality remains exceedingly low in later studies (0.33% of patients). In conclusion, efficacy and safety of immune checkpoint inhibitors appear to be reasonably predicted from the dose-finding portion of phase I trials, indicating that the fast-track development of these agents is safe and justified. Clin Cancer Res; 24(8); 1785-94. ©2017 AACR . ©2017 American Association for Cancer Research.

75 FR 27327 - National Institute on Disability and Rehabilitation Research (NIDRR)-Disability and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-14

... Centers (RRTCs)-- Effective Vocational Rehabilitation (VR) Service Delivery Practices Catalog of Federal... priority for an RRTC on Effective Vocational Rehabilitation (VR) Service Delivery Practices. The Assistant... priority. Effective Vocational Rehabilitation (VR) Service Delivery Practices Background: The...

Intelligent fault recognition strategy based on adaptive optimized multiple centers

NASA Astrophysics Data System (ADS)

Zheng, Bo; Li, Yan-Feng; Huang, Hong-Zhong

2018-06-01

For the recognition principle based optimized single center, one important issue is that the data with nonlinear separatrix cannot be recognized accurately. In order to solve this problem, a novel recognition strategy based on adaptive optimized multiple centers is proposed in this paper. This strategy recognizes the data sets with nonlinear separatrix by the multiple centers. Meanwhile, the priority levels are introduced into the multi-objective optimization, including recognition accuracy, the quantity of optimized centers, and distance relationship. According to the characteristics of various data, the priority levels are adjusted to ensure the quantity of optimized centers adaptively and to keep the original accuracy. The proposed method is compared with other methods, including support vector machine (SVM), neural network, and Bayesian classifier. The results demonstrate that the proposed strategy has the same or even better recognition ability on different distribution characteristics of data.

77 FR 8223 - Applications for New Awards; National Institute on Disability and Rehabilitation Research...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-14

...)--Center on Knowledge Translation for Disability and Rehabilitation Research (KTDRR Center) Notice inviting... Research Projects (DRRP) Requirements Absolute Priority 2--Center on Knowledge Translation for Disability... Applications Applications for grants under the Center on Knowledge Translation for Disability and...

76 FR 79701 - Bristol-Myers Squibb Co. et al.; Withdrawal of Approval of 70 New Drug Applications and 97...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-22

...: Florine Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0411... Drug Applications; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction...

76 FR 64951 - Apothecon et al.; Withdrawal of Approval of 103 New Drug Applications and 35 Abbreviated New Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-19

... INFORMATION CONTACT: Florine Purdie, Center for Drug Evaluation and Research, Food and Drug Administration... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0026... Applications; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The...

76 FR 32364 - Collaboration in Regulatory Science and Capacity To Advance Global Access to Safe Vaccines and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-06

...] Collaboration in Regulatory Science and Capacity To Advance Global Access to Safe Vaccines and Biologicals... and other biologicals that meet international standards. The goal of FDA's Center for Biologics... oversight of influenza and other vaccines and biologicals by supporting analysis, synthesis, and application...

78 FR 52535 - Withdrawal of Approval of New Animal Drug Applications; Quali-Tech Products, Inc.; Bambermycins...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0002...; Tylosin; Virginiamycin AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...: David Alterman, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl...

75 FR 72829 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-26

... and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets..., Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg... Federal Register. Instead, the Agency now posts this information on the Internet on FDA's home page at...

Structure-Guided Optimization of HIV Integrase Strand Transfer Inhibitors | Center for Cancer Research

Cancer.gov

Integrase mutations can reduce the effectiveness of the first-generation FDA-approved integrase strand transfer inhibitors (INSTIs), raltegravir (RAL) and elvitegravir (EVG). The second-generation agent, dolutegravir (DTG), has enjoyed considerable clinical success; however, resistancecausing mutations that diminish the efficacy of DTG have appeared. Our current findings

76 FR 80952 - Request for Nominations for Voting Members on a Public Advisory Committee; Food Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-27

... life science, food science, risk assessment, nutrition, food technology, molecular biology, and other... chemistry or food science to serve on the Food Advisory Committee, Center for Food Safety and Applied Nutrition, Office of Regulations, Policy, and Social Sciences. FDA has a special interest in ensuring that...

75 FR 15376 - Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-29

... already published by FDA in 2004 summarizing its survey research results on the public health impacts of... and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 3238, Silver... Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401...

78 FR 20924 - Center for Biologics Evaluation and Research eSubmitter Pilot Evaluation Program for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0248... Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... sponsors of investigational new drug (IND) applications to participate in a pilot evaluation program for...

77 FR 52745 - Leveraging Registries With Medical Device Data for Postmarket Surveillance and Evidence Appraisal...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-30

... the Total Product Life Cycle AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public... Evidence Appraisal Throughout the Total Product Life Cycle.'' The topic to be discussed is best practices...-cycle. For these reasons, FDA's Center for Devices and Radiological Health (CDRH) uses registries to...

76 FR 12563 - Amendments to General Regulations of the Food and Drug Administration; Confirmation of Effective...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-08

... Smoking Prevention and Tobacco Control Act, by revising the Agency's regulations to require tobacco..., 2010 (75 FR 73951). The direct final rule amends certain general regulations of FDA to include tobacco..., 2011. FOR FURTHER INFORMATION CONTACT: Gerie A. Voss, Center for Tobacco Products, Food and Drug...

76 FR 21378 - Agency Information Collection Activities; Proposed Collection; Comment Request; Request for...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-15

... to be so designated must send a written request to the Director, Center for Food Safety and Applied... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0264... as Country Not Subject to the Restrictions Applicable to Human Food and Cosmetics Manufactured From...

76 FR 35897 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-20

... nonambulatory disabled cattle, and mechanically separated (MS)(Beef). Under the regulations, no human food or... must send a written request to the Director, Center for Food Safety and Applied Nutrition (CFSAN). The... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0264...

77 FR 16806 - Codex Alimentarius Commission: Meeting of the Codex Committee on Residues of Veterinary Drugs in...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-22

... Alimentarius Commission: Meeting of the Codex Committee on Residues of Veterinary Drugs in Food AGENCY: Office... on Residues of Veterinary Drugs in Foods (CCRVDF) of the Codex Alimentarius Commission (Codex), which... Evaluation, HFV-100, FDA, Center for Veterinary Medicine, 7520 Standish Place, Rockville, MD 20855, Telephone...

Food safety concerns in the U.S. and research on Shiga Toxin-producing E. coli

USDA-ARS?s Scientific Manuscript database

In the U.S., there are several government agencies that deal with food safety. Under the Department of Health and Human Services, there are the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). The CDC collaborates with state agencies, private organizatio...

78 FR 66745 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-06

... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD...], Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7520 Standish Pl... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369...

78 FR 37230 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-20

... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD...], Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7519 Standish Pl... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369...

77 FR 31368 - Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-25

... the Research and Development of Tobacco Products'' to the Center for Tobacco Products, Food and Drug...] Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products... and Investigators on the Research and Development of Tobacco Products.'' This guidance describes FDA's...

76 FR 60506 - Request for Notification From Industry Organizations Interested in Participating in the Selection...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-29

... Products Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food... Biological Products Advisory Committee for the Center for Biologics Evaluation and Research (CBER) notify FDA... Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448...

77 FR 10536 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-22

... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver..., Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7519 Standish Pl... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369...

78 FR 55671 - Menthol in Cigarettes, Tobacco Products; Request for Comments; Extension of Comment Period

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-11

.... Marthaler, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1140 [Docket No. FDA-2013-N-0521] Menthol in Cigarettes, Tobacco Products; Request for Comments; Extension of Comment...

77 FR 74669 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-17

... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD...], Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7519 Standish Pl... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369...

77 FR 16784 - E. & J. Gallo Winery; Filing of Color Additive Petition

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-22

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 73 [Docket No. FDA-2012-C-0224] E. & J. Gallo Winery; Filing of Color Additive Petition AGENCY: Food and Drug..., Acting Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition. [FR Doc...

78 FR 16679 - Center for Drug Evaluation and Research Medical Policy Council; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-18

... Council to ensure better coordination of medical policy development and implementation within CDER and... and implementation. II. Range of Medical Policy Issues To Be Considered FDA envisions a variety of... to other products; or Strategies for implementation of a new policy. III. Establishment of a Docket...

21 CFR 610.68 - Exceptions or alternatives to labeling requirements for biological products held by the Strategic...

Code of Federal Regulations, 2010 CFR

2010-04-01

... requirements for biological products held by the Strategic National Stockpile. 610.68 Section 610.68 Food and... GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling Standards § 610.68 Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile. (a) The appropriate FDA Center...

Severe methemoglobinemia and hemolytic anemia from aniline purchased as 2C-E (4-ethyl-2,5-dimethoxyphenethylamine), a recreational drug, on the Internet - Oregon, 2011.

PubMed

2012-02-10

In August 2011, two men in Oregon drank a liquid they believed to be 2C-E (4-ethyl-2,5-dimethoxyphenethylamine), a psychoactive stimulant used as a recreational drug, after purchasing it on the Internet. Fifteen minutes after ingestion, the men became cyanotic and subsequently were treated for refractory methemoglobinemia and hemolytic anemia. The Oregon Poison Center, Oregon Public Health Division, Drug Enforcement Administration (DEA), and Food and Drug Administration (FDA) jointly investigated to determine the cause of the poisoning and identify other cases. The Oregon Poison Center and Oregon Public Health Division promptly alerted health-care providers and public health agencies and searched for additional cases. DEA confiscated all product remaining in the men's possession, and FDA identified the substance as aniline, an industrial solvent known to cause methemoglobinemia. One patient reported purchasing the substance from the Internet site of a Chinese chemical company. No additional cases were identified by investigators. Purchase of chemicals from unregulated Internet sources poses a serious risk to purchasers from product contamination and substitution.

[Supervision, administration and standard research related to tissue engineered medical products].

PubMed

Xi, Ting-fei; Chen, Liang; Zhao, Peng

2003-11-01

Tissue engineering advance in supplying the reparative and reconstructive medicine with promising tissue engineered medical products(TEMPs) and the new therapy alternative. The related supervision and administration of TEMPs is being developed and the standard research of TEMPs is also in progress. The Food and Drug Administration(FDA) of the United States has treated TEMPs as combined products and supervised them according to the level of risk to patients. Lately, FDA has determined that the Center for Devices and Radiological Health (CDRH) should take charge of examination and approval of TEMPs, with the cooperation of the Center for Biological Evaluations and Research(CBER). The regulatory controls have been established respectively in European Union and Japan. In China, TEMPs are identified as medical devices combined with cells. The Department of Medical Device of the State Food and Drug Administration (SFDA) is responsible for the examination and approval of TEMPs, and National Institute for the Control of Pharmaceutical & Biological Products(NICPBP) is responsible for evaluation tests. The standards of TEMPs are formulated mainly by the American Society of Testing Materials(ASTM) and International Standardization Organization(ISO).

Laboratory, Environmental, and Epidemiologic Investigation and Regulatory Enforcement Actions in Response to an Outbreak of Salmonella Bredeney Infections Linked to Peanut Butter

PubMed Central

Viazis, Stelios; Beal, Jennifer K.; Monahan, Caitlin; Lanier, William A.; Kreil, Katherine R.; Melka, David C.; Boden, William D.; Dion, Jamie L.; Miller, Zachary A.; Nguyen, Thai-An; Gieraltowski, Laura B.; Zink, Donald L.

2015-01-01

Background. In September 2012, the Centers for Disease Control and Prevention (CDC), U.S. Food and Drug Administration (FDA), and state and local partners investigated an outbreak of Salmonella enterica serovar Bredeney linked to peanut butter (PB). Methods. A case was defined as infection with the outbreak strain of Salmonella Bredeney between June 1, 2012 and October 31, 2012. Food exposure questionnaires were analyzed by the CDC to determine the food vehicle. The FDA reviewed production information from Retail Chain A's sole supplier of PB, Company A. The PB samples collected from case-patients and Company A were tested for Salmonella. Results. Forty-two case-patients from 20 states were identified. Of 33 case-patients from whom food exposure information was obtained, 25 (76%) shopped at Retail Chain A and 25 (100%) purchased Company A PB. Three state health departments isolated the outbreak strain from opened jars of PB collected from case-patients. The FDA investigators identified multiple deficiencies in current Good Manufacturing Practices (cGMPs) in Company A's manufacturing facility and determined that internal controls were insufficient to prevent shipment of contaminated product. The FDA isolated the outbreak strain of Salmonella Bredeney from implicated product collected at the firm and the environment of the firm's food production facility. Conclusions. Timely laboratory, investigational, and epidemiologic data led to the voluntary recall of PB by Company A. The FDA suspended Company A's food facility registration, prohibiting the firm from introducing food into interstate commerce. This outbreak underscores the need for effective preventive controls, including robust internal environmental monitoring programs, appropriate action in response to contamination findings, and an improved understanding of food safety at the managerial and corporate levels. PMID:26389125

The Role of Adverse Event Reporting in the FDA Response to a Multistate Outbreak of Liver Disease Associated with a Dietary Supplement

PubMed Central

DeBeck, Heidi J.; LeBlanc, Pamela; Mogen, Kathryn M.; Wolpert, Beverly J.; Sabo, Jonathan L.; Salter, Monique; Seelman, Sharon L.; Lance, Susan E.; Monahan, Caitlin; Steigman, David S.; Gensheimer, Kathleen

2015-01-01

Objective Liver disease is a potential complication from using dietary supplements. This study investigated an outbreak of non-viral liver disease associated with the use of OxyELITE ProTM, a dietary supplement used for weight loss and/or muscle building. Methods Illness details were ascertained from MedWatch reports submitted to the U.S. Food and Drug Administration (FDA) describing consumers who ingested OxyELITE Pro alone or in combination with other dietary supplements. FDA's Forensic Chemistry Center analyzed samples of OxyELITE Pro. Results From February 2012 to February 2014, FDA received 114 reports of adverse events of all kinds involving consumers who ingested OxyELITE Pro. The onset of illness for the first report was December 2010 and for the last report was January 2014. Thirty-three states, two foreign nations, and Puerto Rico submitted reports. Fifty-five of the reports (48%) described liver disease in the absence of viral infection, gallbladder disease, autoimmune disease, or other known causes of liver damage. A total of 33 (60%) of these patients were hospitalized, and three underwent liver transplantation. In early 2013, OxyELITE Pro products entered the market with a formulation distinct from products sold previously. The new formulation replaced 1,3-dimethylamylamine with aegeline. However, the manufacturer failed to submit to FDA a required “new dietary ingredient” notice for the use of aegeline in OxyELITE Pro products. Laboratory analysis identified no drugs, poisons, pharmaceuticals, toxic metals, usnic acid, N-Nitroso-fenfluramine, pyrrolizidine alkaloids, aristocholic acid, or phenethylamines in the products. Conclusions Vigilant surveillance is required for adverse events linked to the use of dietary supplements. PMID:26327730

Addressing the evidence for FDA nicotine replacement therapy label changes: a policy statement of the Association for the Treatment of Tobacco use and Dependence and the Society for Research on Nicotine and Tobacco.

PubMed

Fucito, Lisa M; Bars, Matthew P; Forray, Ariadna; Rojewski, Alana M; Shiffman, Saul; Selby, Peter; West, Robert; Foulds, Jonathan; Toll, Benjamin A

2014-07-01

Cigarette smoking creates a substantial public health burden. Identifying new, effective smoking cessation interventions that optimize existing interventions and promoting effective use of approved medications is a priority. When used as directed, nicotine replacement therapy (NRT) aids smoking cessation, but there is opportunity for improving its effectiveness. Until recently, NRT use guidelines advised smokers to begin using NRT on their quit date, only to use 1 NRT formulation at a time, to refrain from using NRT while smoking, and to stop NRT within 3 months regardless of progress. The Food and Drug Administration (FDA) issued a recent announcement allowing for NRT labeling changes with applications from pharmaceutical companies for such changes, and we applaud this decision. Nevertheless, additional revisions are warranted by current research. There is robust evidence that combining a longer-acting form (e.g., patch) with a shorter-acting form (e.g., lozenge) is more effective than NRT monotherapy and is safe. Moreover, extant evidence suggests that NRT use prior to a quit attempt or for smoking reduction as part of a quit attempt is safe and as effective as starting NRT on quit date. Specifically, prequit nicotine patch increases quit rates and may engage additional recalcitrant smokers. Last, NRT use longer than 3 months is safe and may be beneficial for relapse prevention in some smokers. This report summarizes the FDA announcement, reviews the evidence for further revisions to current FDA NRT guidelines, and makes recommendations for over-the-counter (OTC) NRT labeling to allow for (1) combined use of faster-acting NRT medications with nicotine patch, (2) nicotine patch use prior to quit date or NRT for smoking reduction as part of a quit attempt, and (3) prolonged NRT for up to 6 months without healthcare provider consultation. © The Author 2014. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Innovative postmarket device evaluation using a quality registry to monitor thoracic endovascular aortic repair in the treatment of aortic dissection.

PubMed

Beck, Adam W; Lombardi, Joseph V; Abel, Dorothy B; Morales, J Pablo; Marinac-Dabic, Danica; Wang, Grace; Azizzadeh, Ali; Kern, John; Fillinger, Mark; White, Rodney; Cronenwett, Jack L; Cambria, Richard P

2017-05-01

United States Food and Drug Administration (FDA)-mandated postapproval studies have long been a mainstay of the continued evaluation of high-risk medical devices after initial marketing approval; however, these studies often present challenges related to patient/physician recruitment and retention. Retrospective single-center studies also do not fully represent the spectrum of real-world performance nor are they likely to have a sufficiently large enough sample size to detect important signals. In recent years, The FDA Center for Devices and Radiological Health has been promoting the development and use of patient registries to advance infrastructure and methodologies for medical device investigation. The FDA 2012 document, "Strengthening the National System for Medical Device Post-market Surveillance," highlighted registries as a core foundational infrastructure when linked to other complementary data sources, including embedded unique device identification. The Vascular Quality Initiative (VQI) thoracic endovascular aortic repair for type B aortic dissection project is an innovative method of using quality improvement registries to meet the needs of device evaluation after market approval. Here we report the organization and background of this project and highlight the innovation facilitated by collaboration of physicians, the FDA, and device manufacturers. This effort used an existing national network of VQI participants to capture patients undergoing thoracic endovascular aortic repair for acute type B aortic dissection within a registry that aligns with standard practice and existing quality efforts. The VQI captures detailed patient, device, and procedural data for consecutive eligible cases under the auspices of a Patient Safety Organization (PSO). Patients were divided into a 5-year follow-up group (200 acute; 200 chronic dissections) and a 1-year follow-up group (100 acute; 100 chronic). The 5-year cohort required additional imaging details, and the 1-year group required standard VQI registry data entry. The sample size of patients in each of the 5-year acute and chronic dissection arms was achieved ≤24 months of project initiation, and data capture for the 1-year follow-up group is also nearly complete. Data completeness and follow-up has been excellent, and the two FDA-approved devices for dissection are equally represented. Although the completeness of long-term follow-up is yet to be determined, the rapidity of data collection supports the use of this construct for device assessment after market approval. The alignment of this effort with routine clinical practice and ongoing quality improvement initiatives is critical and has required minimal additional effort by practitioners, thus facilitating patient inclusion. Importantly, the success and development of this unique project has helped inform FDA strategy for future device evaluation after market approval. Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

78 FR 34901 - Final Priority; National Institute on Disability and Rehabilitation Research-Advanced...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-11

... Institute on Disability and Rehabilitation Research--Advanced Rehabilitation Research Training Program... priority for the Advanced Rehabilitation Research Training (ARRT) program under the Disability and Rehabilitation Research Projects and Centers Program administered by the National Institute on Disability and...

78 FR 26509 - Final Priority; National Institute on Disability and Rehabilitation Research-Disability and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-07

... Institute on Disability and Rehabilitation Research--Disability and Rehabilitation Research Projects... Rehabilitative Services announces a priority under the Disability Rehabilitation Research Projects and Centers Program administered by the National Institute on Disability and Rehabilitation Research (NIDRR...

Job Needs and Priorities Report, Phase 2: Action Plans : Northeast Region

DOT National Transportation Integrated Search

2016-08-01

The Northeast Transportation Workforce Center (NETWC) is housed at the University of Vermont Transportation Research Center (UVM TRC). It has collaborated in this effort with the Center for Advanced Infrastructure and Transportation (CAIT). The NE re...

77 FR 34359 - Applications for New Awards: Disability and Rehabilitation Research Projects and Centers Program...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-11

... Projects and Centers Program; Traumatic Brain Injury Model Systems Centers AGENCY: Office of Special... Brain Injury Model Systems Centers (TBIMS). Notice inviting applications for new awards for fiscal year... 28, 2006 (71 FR 25472). The Traumatic Brain Injury Model Systems Centers priority is from the notice...

FDA toxicity databases and real-time data entry.

PubMed

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.

Pharmacotherapeutics of Intranasal Scopolamine: FDA Regulations and Procedures for Clinical Applications

NASA Technical Reports Server (NTRS)

Das, H.; Daniels, V. R.; Vaksman, Z.; Boyd, J. L.; Buckey, J. C.; Locke, J. P.; Putcha, L.

2007-01-01

Space Motion Sickness (SMS) is commonly experienced by astronauts and often requires treatment with medications during the early flight days of a space mission. Bioavailability of oral (PO) SMS medications is often low and highly variable; additionally, physiological changes in a microgravity environment exacerbate variability and decrease bioavailability. These factors prompted NASA to develop an intranasal dosage form of scopolamine (INSCOP) suitable for the treatment of SMS. However, to assure safety and efficacy of treatment in space, NASA physicians prescribe commercially available pharmaceutical products only. Development of a pharmaceutical preparation for clinical use must follow distinct clinical phases of testing, phase I through IV to be exact, before it can be approved by the FDA for approval for clinical use. After a physician sponsored Investigative New Drug (IND) application was approved by the FDA, a phase I clinical trial of INSCOP formulation was completed in normal human subjects and results published. The current project includes three phase II clinical protocols for the assessment of pharmacokinetics and pharmacodynamics (PK/PD), efficacy, and safety of INSCOP. Three clinical protocols that were submitted to FDA to accomplish the project objectives: 1) 002-A, a FDA Phase II dose ranging study with four dose levels between 0.1 and 0.4 mg in 12 subjects to assess PK/PD, 2) 002-B, a phase II clinical efficacy study in eighteen healthy subjects to compare efficacy of 0.2 (low dose) and 0.4 mg (high dose) INSCOP for prophylactic treatment of motion-induces (off-axis vertical rotation) symptoms, and (3) 002-C, a phase II clinical study with twelve subjects to determine bioavailability and pharmacodynamics of two doses (0.2 and 0.4 mg) of INSCOP in simulated microgravity, antiorthostatic bedrest. All regulatory procedures were competed that include certification for Good laboratory Procedures by Theradex , clinical documentation, personnel training, selection of clinical research operations contractor, data capturing and management, and annual reporting of results to FDA were successfully completed. Protocol 002-A was completed and sample and data analysis is currently in progress. Protocol 002-B is currently in progress at Dartmouth Hitchcock Medical Center and Protocol 002-C has been submitted to the FDA and will be implemented at the same contractor site as 002-A. An annual report was filed as required by FDA on the results of Protocol 002-A. Once all the three Phase II protocols are completed, a New Drug Administration application will be filed with FDA for Phase III clinical assessment and approval for marketing of the formulation. A commercial vendor will be identified for this phase. This is critical for making this available for treatment of SMS in astronauts and military personnel on duty. Once approved by FDA, INSCOP can be also used by civilian population for motion sickness associated with recreational travel and other ailments that require treatment with anticholinergic drugs.

Volpe Center Annual Accomplishments: Advancing Transportation Innovation for the Public Good - January 2018

DOT National Transportation Integrated Search

2018-01-01

The Volpe Centers Annual Accomplishments highlights our best work of 2017 and illustrates the sustained impact of the Volpe Center in supporting the U.S. DOTs top priorities and strategic goals: safety, infrastructure, innovation, and accountab...

Central site monitoring: results from a test of accuracy in identifying trials and sites failing Food and Drug Administration inspection.

PubMed

Lindblad, Anne S; Manukyan, Zorayr; Purohit-Sheth, Tejashri; Gensler, Gary; Okwesili, Paul; Meeker-O'Connell, Ann; Ball, Leslie; Marler, John R

2014-04-01

Site monitoring and source document verification account for 15%-30% of clinical trial costs. An alternative is to streamline site monitoring to focus on correcting trial-specific risks identified by central data monitoring. This risk-based approach could preserve or even improve the quality of clinical trial data and human subject protection compared to site monitoring focused primarily on source document verification. To determine whether a central review by statisticians using data submitted to the Food and Drug Administration (FDA) by clinical trial sponsors can identify problem sites and trials that failed FDA site inspections. An independent Analysis Center (AC) analyzed data from four anonymous new drug applications (NDAs) where FDA had performed site inspections overseen by FDA's Office of Scientific Investigations (OSI). FDA team members in the OSI chose the four NDAs from among all NDAs with data in Study Data Tabulation Model (SDTM) format. Two of the NDAs had data that OSI had deemed unreliable in support of the application after FDA site inspections identified serious data integrity problems. The other two NDAs had clinical data that OSI deemed reliable after site inspections. At the outset, the AC knew only that the experimental design specified two NDAs with significant problems. FDA gave the AC no information about which NDAs had problems, how many sites were inspected, or how many were found to have problems until after the AC analysis was complete. The AC evaluated randomization balance, enrollment patterns, study visit scheduling, variability of reported data, and last digit reference. The AC classified sites as 'High Concern', 'Moderate Concern', 'Mild Concern', or 'No Concern'. The AC correctly identified the two NDAs with data deemed unreliable by OSI. In addition, central data analysis correctly identified 5 of 6 (83%) sites for which FDA recommended rejection of data and 13 of 15 sites (87%) for which any regulatory deviations were identified during inspection. Of the six sites for which OSI reviewed inspections and found no deviations, the central process flagged four at the lowest level of concern, one at a moderate level, and one was not flagged. Central data monitoring during the conduct of a trial while data checking was in progress was not evaluated. Systematic central monitoring of clinical trial data can identify problems at the same trials and sites identified during FDA site inspections. Central data monitoring in conjunction with an overall monitoring process that adapts to identify risks as a trial progresses has the potential to reduce the frequency of site visits while increasing data integrity and decreasing trial costs compared to processes that are dependent primarily on source documentation.

Personalized Medicine Tackles Clinical Resistance: Alectinib in ALK-Positive Non-Small Cell Lung Cancer Progressing on First-Generation ALK Inhibitor.

PubMed

Skoulidis, Ferdinandos; Papadimitrakopoulou, Vassiliki A

2016-11-01

Over the last 2 years, our therapeutic armamentarium against genomically defined subgroups of non-small cell lung cancer (NSCLC) has extended to patients with acquired resistance to front-line targeted therapy. Alectinib (Alecensa; Roche/Genentech), a second-generation, orally active, potent, and highly selective inhibitor of anaplastic lymphoma kinase (ALK), is indicated for patients with metastatic, ALK rearrangement-positive NSCLC whose disease has worsened after treatment with crizotinib or who became intolerant to the drug. Alectinib received orphan drug designation, breakthrough therapy designation, priority review status, and accelerated approval by the FDA. Clin Cancer Res; 22(21); 5177-82. ©2016 AACR. ©2016 American Association for Cancer Research.

Sustaining “Meaningful Use” of Health Information Technology in Low-Resource Practices

PubMed Central

Green, Lee A.; Potworowski, Georges; Day, Anya; May-Gentile, Rachelle; Vibbert, Danielle; Maki, Bruce; Kiesel, Leslie

2015-01-01

PURPOSE The implementation of electronic health records (EHRs) has been extensively studied, but their maintenance once implemented has not. The Regional Extension Center (REC) program provides implementation assistance to priority practices—those with limited financial, technical, and organizational resources—but the assistance is time limited. Our objective was to identify potential barriers to maintenance of meaningful use of EHRs in priority primary care practices using a qualitative observational study for federally qualified health centers (FQHCs) and priority practices in Michigan. METHODS We conducted cognitive task analysis (CTA) interviews and direct observations of health information technology implementation in FQHCs. In addition, we conducted semistructured interviews with implementation specialists serving priority practices to detect emergent themes relevant to maintenance. RESULTS Maintaining EHR technology will require ongoing expert technical support indefinitely beyond implementation to address upgrades and security needs. Maintaining meaningful use for quality improvement will require ongoing support for leadership and change management. Priority practices not associated with larger systems lack access to the necessary technical expertise, financial resources, and leverage with vendors to continue alone. Rural priority practices are particularly challenged, because expertise is often not available locally. CONCLUSIONS Priority practices, especially in rural areas, are at high risk for falling on the wrong side of a “digital divide” as payers and regulators enact increasing expectations for EHR use and information management. For those without affiliation to maintain the necessary expert staff, ongoing support will be needed for those practices to remain viable. PMID:25583887

Sustaining "meaningful use" of health information technology in low-resource practices.

PubMed

Green, Lee A; Potworowski, Georges; Day, Anya; May-Gentile, Rachelle; Vibbert, Danielle; Maki, Bruce; Kiesel, Leslie

2015-01-01

The implementation of electronic health records (EHRs) has been extensively studied, but their maintenance once implemented has not. The Regional Extension Center (REC) program provides implementation assistance to priority practices-those with limited financial, technical, and organizational resources-but the assistance is time limited. Our objective was to identify potential barriers to maintenance of meaningful use of EHRs in priority primary care practices using a qualitative observational study for federally qualified health centers (FQHCs) and priority practices in Michigan. We conducted cognitive task analysis (CTA) interviews and direct observations of health information technology implementation in FQHCs. In addition, we conducted semistructured interviews with implementation specialists serving priority practices to detect emergent themes relevant to maintenance. Maintaining EHR technology will require ongoing expert technical support indefinitely beyond implementation to address upgrades and security needs. Maintaining meaningful use for quality improvement will require ongoing support for leadership and change management. Priority practices not associated with larger systems lack access to the necessary technical expertise, financial resources, and leverage with vendors to continue alone. Rural priority practices are particularly challenged, because expertise is often not available locally. Priority practices, especially in rural areas, are at high risk for falling on the wrong side of a "digital divide" as payers and regulators enact increasing expectations for EHR use and information management. For those without affiliation to maintain the necessary expert staff, ongoing support will be needed for those practices to remain viable. © 2015 Annals of Family Medicine, Inc.

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 nanomedicine research and development (R&D) and erode public acceptance of nanoproducts. The end-result of this could be a delay or loss of commercialized nanoproducts. Whether the FDA eventually creates new regulations, tweaks existing ones or establishes a new regulatory center to handle nanoproducts, for the time being it should at least look at nanoproducts on a case-by-case basis. The FDA should not attempt regulation of nanomedicine by applying existing statutes alone, especially where scientific evidence suggests otherwise. Incorporating nanomedicine regulation into the current regulatory scheme is a poor idea. Regulation of nanomedicine must balance innovation and R&D with the principle of ensuring maximum public health protection and safety.

78 FR 26513 - Final Priorities and Definitions-NIDRR DRRP-Community Living and Participation, Health and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-07

... and refined analyses of data, producing observational findings, and creating other sources of research... Services announces priorities and definitions for the Disability and Rehabilitation Research Projects and Centers Program administered by the National Institute on Disability and Rehabilitation Research (NIDRR...

77 FR 40601 - Final Priority: Disability and Rehabilitation Research Projects and Centers Program; Disability...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-10

... analyses of data, producing observational findings, and creating other sources of research-based... provide a rationale for the stage of research being proposed and the research methods associated with the... DEPARTMENT OF EDUCATION Final Priority: Disability and Rehabilitation Research Projects and...

78 FR 29672 - Cardiovascular Devices; Reclassification of External Counter-Pulsating Devices for Treatment of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-21

... Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Angela Krueger, Center for... 214 (D.C. Cir. 1985); Contact Lens Association v. FDA, 766 F.2d 592 (D.C. Cir.), cert. denied, 474 U.S... lymphedema) and/ or induration (e.g., stasis dermatitis) associated with chronic venous stasis; venous stasis...

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

... actively involved in both basic and applied research in coastal waters of the northern Gulf of Mexico. The... between the Center for Food Safety and Applied Nutrition (CFSAN) and the Marine Environmental Sciences Consortium/Dauphin Island Sea Lab (DISL). The goal of the DISL is marine science education, basic and applied...

77 FR 27463 - Device Improvements for Pediatric X-Ray Imaging; Public Meeting; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-10

... pediatric x-ray imaging that may benefit from standards development or further research. DATES: Date and... held at FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room..., Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4527, Silver Spring, MD 20993...

78 FR 64505 - Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-29

... Advisory Committee, Office of Science, Center for Tobacco Products. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its... matters related to financial holdings, employment, and research grants and/or contracts to permit...

77 FR 61007 - Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-05

... Advisory Committee, Office of Science, Center for Tobacco Products. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its... matters related to financial holdings, employment, and research grants and/or contracts to permit...

78 FR 45930 - Guidance for Industry: Safety Labeling Changes-Implementation of Section 505(o)(4) of the Federal...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-30

...] Guidance for Industry: Safety Labeling Changes--Implementation of Section 505(o)(4) of the Federal Food...: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51...

FDA grants orphan drug status to selumetinib for neurofibromatosis type 1 (NF1) treatment | Center for Cancer Research

Cancer.gov

The U.S. Food and Drug Administration granted orphan drug status in February to selumetinib for use in patients with the genetic disorder neurofibromatosis type 1 (NF1), who often develop tumors of the peripheral nervous system. Receiving orphan drug designation is a helpful step for selumetinib.

76 FR 59407 - Center for Biologics Evaluation and Research Report of Scientific and Medical Literature and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-26

... test data in the studies: Obtained positive skin tests in index cases by either skin prick or... 20852- 1448. Send one self-addressed adhesive label to assist the office in processing your requests... list of reviewed literature associated with each product. FDA's approach to creating this data file was...

In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products: Workshop Proceedings, Conclusions, and Paths Forward for In Vitro Model Use

EPA Science Inventory

In 2009, the passing of The Family Smoking Prevention and Tobacco Control Act facilitated the establishment of the FDA Center for Tobacco Products (CTP) and gave it regulatory authority over the marketing, manufacture and distribution of tobacco products, including those termed “...

75 FR 48928 - Codex Alimentarius Commission: Meeting of the Codex Committee on Residues of Veterinary Drugs in...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-12

... Alimentarius Commission: Meeting of the Codex Committee on Residues of Veterinary Drugs in Food AGENCY: Office... (USDA), and the U.S. Food and Drug Administration (FDA), Center for Veterinary Medicine, are sponsoring... 19th Session of the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF), which will be...

78 FR 63221 - Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports to the...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0241] Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

75 FR 28257 - Draft Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-20

... Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) are implementing this... search capability for all CDRH guidance documents is available at http://www.fda.gov/cdrh/guidance.html... CDRH and CBER are implementing this provision of the law and providing public notice as required. The...

76 FR 81510 - Draft Guidance for Industry and Food and Drug Administration Staff; the 510(k) Program...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-28

... Memorandum titled ``Guidance on the CDRH Premarket Notification Review Program, 510(k) Memorandum K86-3,'' a... achieves its intended goals. In September 2009, FDA's Center for Devices and Radiological Health (CDRH... regarding the strengths and challenges associated with the 510(k) program. In August 2010, CDRH published...

75 FR 37818 - Issues in the Design and Conduct of Clinical Trials for Antibacterial Drug Development; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-30

... Moser or Lori Benner, Center for Drug Evaluation and Research, Food and Drug Administration, Office of... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001... AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug...

77 FR 50121 - Hospira, Inc.; Withdrawal of Approval of a New Drug Application for DEXTRAN 70

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-20

..., Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike... and Research, by the Commissioner of Food and Drugs, approval of NDA 080- 819, DEXTRAN 70 [6% Dextran... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0840...

78 FR 22817 - Proposed Priority-National Institute on Disability and Rehabilitation Research-Disability and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-17

... Institute on Disability and Rehabilitation Research--Disability and Rehabilitation Research Projects and Centers Program--Rehabilitation Engineering Research Centers AGENCY: Office of Special Education and... Research Projects and Centers Program administered by the National Institute on Disability and...

TU-AB-204-03: Research Activities in Medical Physics

DOE Office of Scientific and Technical Information (OSTI.GOV)

Badano, A.

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.« less

TU-AB-204-01: Device Approval Process

DOE Office of Scientific and Technical Information (OSTI.GOV)

Delfino, J.

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.« less

TU-AB-204-02: Device Adverse Events and Compliance

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gonzales, S.

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.« less

Home - Western Integrated Pest Management Center

Science.gov Websites

Agriculture Communities Natural Areas By State Grants Priorities For Applicants For Recipients Leveraged Funds Regional IPM Centers are supported by the USDA National Institute of Food and Agriculture

Failure mode and effects analysis based risk profile assessment for stereotactic radiosurgery programs at three cancer centers in Brazil.

PubMed

Teixeira, Flavia C; de Almeida, Carlos E; Saiful Huq, M

2016-01-01

The goal of this study was to evaluate the safety and quality management program for stereotactic radiosurgery (SRS) treatment processes at three radiotherapy centers in Brazil by using three industrial engineering tools (1) process mapping, (2) failure modes and effects analysis (FMEA), and (3) fault tree analysis. The recommendations of Task Group 100 of American Association of Physicists in Medicine were followed to apply the three tools described above to create a process tree for SRS procedure for each radiotherapy center and then FMEA was performed. Failure modes were identified for all process steps and values of risk priority number (RPN) were calculated from O, S, and D (RPN = O × S × D) values assigned by a professional team responsible for patient care. The subprocess treatment planning was presented with the highest number of failure modes for all centers. The total number of failure modes were 135, 104, and 131 for centers I, II, and III, respectively. The highest RPN value for each center is as follows: center I (204), center II (372), and center III (370). Failure modes with RPN ≥ 100: center I (22), center II (115), and center III (110). Failure modes characterized by S ≥ 7, represented 68% of the failure modes for center III, 62% for center II, and 45% for center I. Failure modes with RPNs values ≥100 and S ≥ 7, D ≥ 5, and O ≥ 5 were considered as high priority in this study. The results of the present study show that the safety risk profiles for the same stereotactic radiotherapy process are different at three radiotherapy centers in Brazil. Although this is the same treatment process, this present study showed that the risk priority is different and it will lead to implementation of different safety interventions among the centers. Therefore, the current practice of applying universal device-centric QA is not adequate to address all possible failures in clinical processes at different radiotherapy centers. Integrated approaches to device-centric and process specific quality management program specific to each radiotherapy center are the key to a safe quality management program.

78 FR 50370 - Travelers' Information Stations

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-19

... Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743... inspection and copying during normal business hours in the FCC Reference Information Center, Portals II, 445... Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743. U.S. Postal Service...

34 CFR 366.13 - How does the Secretary determine funding priorities?

Code of Federal Regulations, 2011 CFR

2011-07-01

... 34 Education 2 2011-07-01 2010-07-01 true How does the Secretary determine funding priorities? 366.13 Section 366.13 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF SPECIAL EDUCATION AND REHABILITATIVE SERVICES, DEPARTMENT OF EDUCATION CENTERS FOR INDEPENDENT...

77 FR 47495 - Final Priority; Technical Assistance on State Data Collection, Analysis, and Reporting-National...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-08

... intervention and preschool service providers with data on their qualifications, certification, and preparation... Priority; Technical Assistance on State Data Collection, Analysis, and Reporting--National IDEA Technical Assistance Center on Early Childhood Longitudinal Data Systems; Rule #0;#0;Federal Register / Vol. 77, No...

78 FR 36667 - Final Priority; National Institute on Disability and Rehabilitation Research-Disability and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-19

... Institute on Disability and Rehabilitation Research--Disability and Rehabilitation Research Projects and Centers Program--Rehabilitation Engineering Research Centers AGENCY: Office of Special Education and... Research Center (RERC) on Technologies to Support Successful Aging with Disability under the Disability and...

78 FR 22780 - Final Priority; National Institute on Disability and Rehabilitation Research-Disability and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-17

... Institute on Disability and Rehabilitation Research--Disability and Rehabilitation Research Projects and Centers Program--Rehabilitation Engineering Research Centers AGENCY: Office of Special Education and... Research Center (RERC) on Hearing Enhancement under the Disability and Rehabilitation Research Projects and...

A Framework for Incorporating Patient Preferences Regarding Benefits and Risks into Regulatory Assessment of Medical Technologies.

PubMed

Ho, Martin; Saha, Anindita; McCleary, K Kimberly; Levitan, Bennett; Christopher, Stephanie; Zandlo, Kristen; Braithwaite, R Scott; Hauber, A Brett

In response to 2012 guidance in which the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) stated the importance of patient-centric measures in regulatory benefit-risk assessments, the Medical Device Innovation Consortium (MDIC) initiated a project. The project was used to develop a framework to help the Food and Drug Administration (FDA) and industry sponsors understand how patient preferences regarding benefit and risk might be integrated into the review of innovative medical devices. A public-private partnership of experts from medical device industry, government, academia and non-profits collaborated on development of the MDIC patient centered benefit-risk framework. The MDIC Framework examines what patient preference information is and the potential use and value of patient preference information in the regulatory process and across the product development life cycle. The MDIC Framework also includes a catalog of patient preference assessment methods and an agenda for future research to advance the field. This article discusses key concepts in patient preference assessment of particular importance for regulators and researchers that are addressed in the MDIC Framework for patient centered benefit-risk assessment as well as the unique public-private collaboration that led its development. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Teixeira, Flavia C., E-mail: flavitiz@gmail.com; Almeida, Carlos E. de; Saiful Huq, M.

Purpose: The goal of this study was to evaluate the safety and quality management program for stereotactic radiosurgery (SRS) treatment processes at three radiotherapy centers in Brazil by using three industrial engineering tools (1) process mapping, (2) failure modes and effects analysis (FMEA), and (3) fault tree analysis. Methods: The recommendations of Task Group 100 of American Association of Physicists in Medicine were followed to apply the three tools described above to create a process tree for SRS procedure for each radiotherapy center and then FMEA was performed. Failure modes were identified for all process steps and values of riskmore » priority number (RPN) were calculated from O, S, and D (RPN = O × S × D) values assigned by a professional team responsible for patient care. Results: The subprocess treatment planning was presented with the highest number of failure modes for all centers. The total number of failure modes were 135, 104, and 131 for centers I, II, and III, respectively. The highest RPN value for each center is as follows: center I (204), center II (372), and center III (370). Failure modes with RPN ≥ 100: center I (22), center II (115), and center III (110). Failure modes characterized by S ≥ 7, represented 68% of the failure modes for center III, 62% for center II, and 45% for center I. Failure modes with RPNs values ≥100 and S ≥ 7, D ≥ 5, and O ≥ 5 were considered as high priority in this study. Conclusions: The results of the present study show that the safety risk profiles for the same stereotactic radiotherapy process are different at three radiotherapy centers in Brazil. Although this is the same treatment process, this present study showed that the risk priority is different and it will lead to implementation of different safety interventions among the centers. Therefore, the current practice of applying universal device-centric QA is not adequate to address all possible failures in clinical processes at different radiotherapy centers. Integrated approaches to device-centric and process specific quality management program specific to each radiotherapy center are the key to a safe quality management program.« less

Thalidomide and the Titanic: reconstructing the technology tragedies of the twentieth century.

PubMed

Annas, G J; Elias, S

1999-01-01

The Titanic has become a metaphor for the disastrous consequences of an unqualified belief in the safety and invincibility of new technology. Similarly, the thalidomide tragedy stands for all of the "monsters" that can be inadvertently or negligently created by modern medicine. Thalidomide, once banned, has returned to the center of controversy with the Food and Drug Administration's (FDA's) announcement that thalidomide will be placed on the market for the treatment of erythema nodosum leprosum, a severe dermatological complication of Hansen's disease. Although this indication is very restricted, thalidomide will be available for off-label uses once it is on the market. New laws regarding abortion and a new technology, ultrasound, make reasonable the approval of thalidomide for patients who suffer from serious conditions it can alleviate. In addition, the FDA and the manufacturer have proposed the most stringent postmarketing monitoring ever used for a prescription drug, including counseling, contraception, and ultrasonography in the event of pregnancy. The Titanic/thalidomide lesson for the FDA and public health is that rules and guidelines alone are not sufficient to guarantee safety. Continuous vigilance will be required to ensure that all reasonable postmarketing monitoring steps are actually taken to avoid predictable and preventable teratogenic disasters.

The new collaborative path in medical device development: the medical device innovation consortium.

PubMed

Kampfrath, Thomas; Cotten, Steven W

2013-10-01

The United States medical device market is the world's largest with over $100 billion in sales in 2011. Despite robust industry growth, the efficiency of the FDA approval process for moderate-risk (Class II) and high-risk devices (Class III) requiring 510(k) submission or pre-market approval (PMA) has been criticized. Recently, the FDA's Center for Devices and Radiological Health (CDRH) announced the creation of a Medical Device Innovation Consortium (MDIC), a public-private partnership (PPP) to share knowledge in regulatory science. Overarching goals include creating a forum for the exchange of ideas among the FDA, industry, and non-profit entities; providing monetary investments for project proposals prioritized by key working groups; and developing tools that support cost effective innovation, data-driven methodology, and implementation strategies. Clinical chemists and clinical laboratory scientists have several unique opportunities to contribute to the MDIC. These laboratory professionals have invaluable experience with the real-life performance of a variety of medical devices and their expertise can recognize unmet needs and contribute towards the acceleration of device development. Copyright © 2013 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Epidural conduction device fractures and complications of retained fragments.

PubMed

Fischer, Robert

2008-02-01

During the past 3 years, the US Food and Drug Administration (FDA) has received a growing number of adverse event reports on the breakage or fracturing and retention of anesthetic conduction device tips with associated complications. Serious injuries and other problems such as spinal stenosis, nerve root compression, and subcutaneous effusion can result. Several case reports demonstrate how the problems occur; some illustrate the severity of the problem. All cases are from adverse event reports in the FDA Center for Devices and Radiological Health (CDRH) Manufacturer and User Facility Device Experience database. Frequently, in the interest of not causing patient harm, a device fragment might not be removed as long as the patient is not neurologically compromised or at risk for infection or there is little potential for migration of the fragmented piece. On many occasions, the fragments remain in patients without their knowledge. The FDA wants to raise awareness of the problem and its potential impact in creating complications, encourage the practice of informing patients of the fragmented device, and promote reporting of such incidents to CDRH via the MedWatch reporting system. Based on a search of the current literature, recommendations for prevention are suggested.

An Analysis of Applications Development Systems for Remotely Sensed, Multispectral Data for the Earth Observations Division of the NASA Lyndon B. Johnson Space Center

NASA Technical Reports Server (NTRS)

Vanrooy, D. L.; Smith, R. M.; Lynn, M. S.

1974-01-01

An application development system (ADS) is examined for remotely sensed, multispectral data at the Earth Observations Division (EOD) at Johnson Space Center. Design goals are detailed, along with design objectives that an ideal system should contain. The design objectives were arranged according to the priorities of EOD's program objectives. Four systems available to EOD were then measured against the ideal ADS as defined by the design objectives and their associated priorities. This was accomplished by rating each of the systems on each of the design objectives. Utilizing the established priorities, it was determined how each system stood up as an ADS. Recommendations were made as to possible courses of action for EOD to pursue to obtain a more efficient ADS.

76 FR 15964 - Funding Priorities: Disability and Rehabilitation Research Projects and Centers Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-22

... past five years, the DBTACs have published numerous journal articles, held a series of research... and Rehabilitation Research Projects and Centers Program AGENCY: Office of Special Education and... Disability and Rehabilitation Research Projects and Centers Program administered by the National Institute on...

FDA toxicity databases and real-time data entry

DOE Office of Scientific and Technical Information (OSTI.GOV)

Arvidson, Kirk B.

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 distributedmore » 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.« less

National Biocontainment Training Center

DTIC Science & Technology

2014-06-01

of novel antimicrobial compounds with antibacterial activity against TB (Vijayakumar, et al., Dec. 2013, Tuberculosis). She has also developed...Nanoluc. (a) insert the Nanoluc after the signal peptide , (b) insert the Nanoluc before the RSKR site, (c) insert the Nanoluc before the RRLL site...biological safe techniques. This training took place in Dallas, Texas. Trainers: Vickie Jones and Jason Hardcastle. Food and Drug Administration (FDA

Mentored Research | Cancer Prevention Fellowship Program

Cancer.gov

The major activity for Cancer Prevention Fellows is mentored research. All fellows are expected to develop original scientific projects and to report their findings at scientific meetings and in leading journals. Fellows select preceptors, who guide and enrich the fellow’s experience, from skilled investigators across all NCI divisions or participating FDA centers. Over 100 NCI staff members have served as preceptors.

CIRM Alpha Stem Cell Clinics: Collaboratively Addressing Regenerative Medicine Challenges.

PubMed

Jamieson, Catriona H M; Millan, Maria T; Creasey, Abla A; Lomax, Geoff; Donohoe, Mary E; Walters, Mark C; Abedi, Mehrdad; Bota, Daniela A; Zaia, John A; Adams, John S

2018-06-01

The California Institute for Regenerative Medicine (CIRM) Alpha Stem Cell Clinic (ASCC) Network was launched in 2015 to address a compelling unmet medical need for rigorous, FDA-regulated, stem cell-related clinical trials for patients with challenging, incurable diseases. Here, we describe our multi-center experiences addressing current and future challenges. Copyright © 2018 Elsevier Inc. All rights reserved.

Preceptorships | Cancer Prevention Fellowship Program

Cancer.gov

The major activity for Cancer Prevention Fellows is mentored research. All fellows are expected to develop original scientific projects and to report their findings at scientific meetings and in leading journals. Preceptors who serve to guide and enrich each fellow's experience are selected from skilled investigators across all NCI divisions, participating FDA centers, or local academic institutions. Over 100 NCI staff members have served as preceptors.

Immunotoxin Targeting Glypican-3 Effective against Liver Tumors | Center for Cancer Research

Cancer.gov

Worldwide, liver cancer is the fifth most common malignancy, and hepatocellular carcinoma (HCC) makes up about two-thirds of those cases. Unfortunately, surgery is still the most effective treatment for HCC but is only available to patients diagnosed at early stages. HCC is known for being particularly drug resistant, sorafenib being the only FDA-approved chemotherapy

75 FR 58411 - Center for Veterinary Medicine eSubmitter Workshop; Public Workshop; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-24

... health industry that submits new animal drug applications to CVM's Office of New Animal Drug Evaluation... agreed to in the Animal Drug User Fee Amendments (ADUFA II) of 2008 ( http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm044941.htm ). The ONADE will be soliciting feedback on both the e...

Activities of the Federal Interagency Workgroup on ...

EPA Pesticide Factsheets

In 2012, four federal agencies signed a Memorandum of Understanding (MOU) establishing a formal mechanism to improve and sustain federal coordination and collaboration on issues related to pharmaceuticals in water. The MOU is in response to the Government Accountability Office recommendation in its August 2011 report “Action Needed to Sustain Agencies’ Collaboration on Pharmaceuticals in Drinking Water.” The signatories are the US Environmental Protection Agency (EPA), US Department of Agriculture/Agricultural Research Service (USDA), US Department of Health and Human Services/Food and Drug Administration (FDA), and US Department of Interior/Geological Survey (USGS). As a result of this agreement, an interagency workgroup (EPA, USGS, FDA, USDA, Army Public Health Center (Provisional), National Toxicology Program, National Oceanic and Atmospheric Administration, and Center for Disease Control and Prevention) was formed to address issues related to the occurrence of pharmaceuticals in water. This Workgroup provides a forum for the exchange of information on pharmaceuticals in the environment, supports coordination of joint studies on pharmaceuticals in the environment, and facilitates interagency consultation on implications of research and analyses derived from shared information. The Workgroup is currently developing a product that will summarize ongoing federal efforts in this area and describe the process for monitoring, evaluating, and reporting to the

Professional Development Priorities Process (Needs Assessment). Leader's Handbook.

ERIC Educational Resources Information Center

Southeast Idaho Teacher Center Consortium, Twin Falls.

Step-by-step instructions are provided for implementing the Professional Development Priorities Process (PDPP), an educational needs assessment process, by a school faculty member with groups of eight peers or more. The essence of PDPP, which was designed at the Southeast Idaho Teacher Center Consortium, is a dynamic group process in which needs…

Obligations to High Priority Target Groups: Philosophical Implications.

ERIC Educational Resources Information Center

Christmas, June Jackson

Community mental health center services must be most plentiful where the need is greatest and must be appropriate and available to meet these needs. The first high priority group, according to statistics on juvenile delinquency, and narcotics, is the black inner city. Socio-psychiatric services, numerous enough in quantity to begin to meet needs…

Priority Determination for AVC Funded R&D Projects.

ERIC Educational Resources Information Center

Wilkinson, Gene L.

As an extension of ideas suggested in an earlier paper which proposed a project control system for Indiana University's Audio-Visual Center (see EM 010 306), this paper examines the establishment of project legitimacy and priority within the system and reviews the need to stimulate specific research proposals as well as generating a matrix of…

Surrogate endpoints and emerging surrogate endpoints for risk reduction of cardiovascular disease.

PubMed

Rasnake, Crystal M; Trumbo, Paula R; Heinonen, Therese M

2008-02-01

This article reviews surrogate endpoints and emerging biomarkers that were discussed at the annual "Cardiovascular Biomarkers and Surrogate Endpoints" symposium cosponsored by the US Food and Drug Administration (FDA) and the Montreal Heart Institute. The FDA's Center for Food Safety and Applied Nutrition (CFSAN) uses surrogate endpoints in its scientific review of a substance/disease relationship for a health claim. CFSAN currently recognizes three validated surrogate endpoints: blood pressure, blood total cholesterol, and blood low-density lipoprotein (LDL) concentration in its review of a health claim for cardiovascular disease (CVD). Numerous potential surrogate endpoints of CVD are being evaluated as the pathophysiology of heart disease is becoming better understood. However, these emerging biomarkers need to be validated as surrogate endpoints before they are used by CFSAN in the evaluation of a CVD health claim.

The US national antimicrobial resistance monitoring system.

PubMed

Gilbert, Jeffrey M; White, David G; McDermott, Patrick F

2007-10-01

The use of antimicrobial agents in food animals can select for resistant bacterial pathogens that may be transmitted to humans via the commercial meat supply. In the USA, the FDA's Center for Veterinary Medicine regulatory duties require a determination that antimicrobial drugs are safe and effective for use in food animals. In addition, a qualitative assessment of risks to human health from antimicrobial resistance requires development. This risk assessment process is supported by data generated by the FDA's National Antimicrobial Resistance Monitoring System (NARMS) for enteric bacteria. NARMS data on antimicrobial susceptibility among Salmonella, Campylobacter, Escherichia coli and Enterococcus is collected. Research activities defining the genetic bases of resistance helps to understand the potential public health risks posed by the spread of antimicrobial resistance from food animal antimicrobial use. These activities help insure that antimicrobials are used judiciously to promote human and animal health.

Services of the CDRH X-ray calibration laboratory and their traceability to National Standards

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cerra, F.; Heaton, H.T.

The X-ray Calibration Laboratory (XCL) of the Center for Devices and Radiological Health (CDRH) provides calibration services for the Food and Drug Administration (FDA). The instruments calibrated are used by FDA and contract state inspectors to verify compliance with federal x-ray performance standards and for national surveys of x-ray trends. In order to provide traceability of measurements, the CDRH XCL is accredited by the National Voluntary Laboratory Accreditation Program (NVLAP) for reference, diagnostic, and x-ray survey instrument calibrations. In addition to these accredited services, the CDRH XCL also calibrates non-invasive kVp meters in single- and three-phase x-ray beams, and thermoluminescentmore » dosimeter (TLD) chips used to measure CT beam profiles. The poster illustrates these services and shows the traceability links back to the National Standards.« less

Regulatory issues for computerized electrocardiographic devices.

PubMed

Muni, Neal I; Ho, Charles; Mallis, Elias

2004-01-01

Computerized electrocardiogram (ECG) devices are regulated in the U.S. by the FDA Center for Devices and Radiological Health (CDRH). This article aims to highlight the salient points of the FDA regulatory review process, including the important distinction between a "tool" claim and a "clinical" claim in the intended use of a computerized ECG device. Specifically, a tool claim relates to the ability of the device to accurately measure a certain ECG parameter, such as T-wave alternans (TWA), while a clinical claim imputes a particular health hazard associated with the identified parameter, such as increased risk of ventricular tachyarrhythmia or sudden death. Given that both types of claims are equally important and receive the same regulatory scrutiny, the manufacturer of a new ECG diagnostic device should consider the distinction and regulatory pathways for approval between the two types of claims discussed in this paper.

Health Extension and Clinical and Translational Science: An Innovative Strategy for Community Engagement.

PubMed

Kaufman, Arthur; Rhyne, Robert L; Anastasoff, Juliana; Ronquillo, Francisco; Nixon, Marnie; Mishra, Shiraz; Poola, Charlene; Page-Reeves, Janet; Nkouaga, Carolina; Cordova, Carla; Larson, Richard S

Health Extension Regional Officers (HEROs) through the University of New Mexico Health Sciences Center (UNMHSC) help to facilitate university-community engagement throughout New Mexico. HEROs, based in communities across the state, link priority community health needs with university resources in education, service, and research. Researchers' studies are usually aligned with federal funding priorities rather than with health priorities expressed by communities. To help overcome this misalignment, the UNM Clinical and Translational Science Center (CTSC) provides partial funding for HEROs to bridge the divide between research priorities of UNMHSC and health priorities of the state's communities. A bidirectional partnership between HEROs and CTSC researchers was established, which led to: 1) increased community engaged studies through the CTSC, 2) the HERO model itself as a subject of research, 3) a HERO-driven increase in local capacity in scholarship and grant writing, and 4) development of training modules for investigators and community stakeholders on community-engaged research. As a result, 5 grants were submitted, 4 of which were funded, totaling $7,409,002.00, and 3 research articles were published. Health extension can serve as a university-funded, community-based bridge between community health needs and Clinical and Translational Science Award (CTSA) research capacity, opening avenues for translational research. © Copyright 2017 by the American Board of Family Medicine.

76 FR 20588 - FDA Food Safety Modernization Act: Focus on Preventive Controls for Facilities; Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-13

.... FDA-2011-N-0251] FDA Food Safety Modernization Act: Focus on Preventive Controls for Facilities... comment. SUMMARY: The Food and Drug Administration (FDA) is announcing a public meeting entitled ``FDA... controls for facilities provisions of the recently enacted FDA Food Safety Modernization Act (FSMA). FDA is...

Energy-efficient virtual optical network mapping approaches over converged flexible bandwidth optical networks and data centers.

PubMed

Chen, Bowen; Zhao, Yongli; Zhang, Jie

2015-09-21

In this paper, we develop a virtual link priority mapping (LPM) approach and a virtual node priority mapping (NPM) approach to improve the energy efficiency and to reduce the spectrum usage over the converged flexible bandwidth optical networks and data centers. For comparison, the lower bound of the virtual optical network mapping is used for the benchmark solutions. Simulation results show that the LPM approach achieves the better performance in terms of power consumption, energy efficiency, spectrum usage, and the number of regenerators compared to the NPM approach.

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 ... Download Drugs@FDA Express for free Search by Drug Name, Active Ingredient, or Application Number Enter at ...

Report from the National Institute of Allergy and Infectious Disease Workshop on Drug Allergy

PubMed Central

Wheatley, Lisa M; Plaut, Marshall; Schwaninger, Julie M; Banerji, Aleena; Castells, Mariana; Finkelman, Fred D.; Gleich, Gerald J.; Guttman-Yassky, Emma; Mallal, Simon A.K.; Naisbitt, Dean J.; Ostrov, David A.; Phillips, Elizabeth J.; Pichler, Werner J.; Platts-Mills, Thomas A. E.; Roujeau, Jean-Claude; Schwartz, Lawrence B.; Trepanier, Lauren A.

2015-01-01

Allergic reactions to drugs are a serious public health concern. In 2013, the National Institute of Allergy and Infectious Diseases, Division of Allergy, Immunology and Transplantation, sponsored a workshop on drug allergy. International experts in the field of drug allergy with backgrounds in allergy, immunology, infectious diseases, dermatology, clinical pharmacology and pharmacogenomics discussed the current state of drug allergy research. These experts were joined by representatives from several NIH Institutes and the U.S. Food and Drug Administration (FDA). The participants identified important advances that make new research directions feasible and made suggestions for research priorities and for development of infrastructure to advance our knowledge of the mechanisms, diagnosis, management, and prevention of drug allergy. The workshop summary and recommendations are presented herein. PMID:26254053

Special report: the truth about condoms. Barriers to better condom "killing people"; regulatory, political hurdles stifle development.

PubMed

1995-01-01

The condom industry in the US is dominated by Carter Wallace and the London International Group. They offer very little product differentiation. Ten years ago, however, two engineers in a small California laboratory began working on a nonlatex condom which would be both stronger and more sensitive than the traditional male latex condom. Their efforts resulted in the development of the polyurethane Avanti condom currently being marketed in thirteen states of the Western US. Made by London International Group plc in Cambridge, England, Avanti should be available nationwide as of April 1995. The public, however, has received only very little information about the product and the US Food and Drug Administration (FDA) is concerned about the safety and efficacy of polyurethane/plastic condoms. Six other condom manufacturers are developing plastic condoms, with at least five such condoms awaiting FDA premarket clearance to be marketed. Recent delays in marketing Avanti are due to disagreements between the manufacturer and the FDA over labeling. Other delays have involved safety and efficacy concerns. Bob Kohmescher, public health analyst with the US Centers for Disease Control office of the assistant director of HIV/AIDS, notes that even his agency is moving slower than expected on the polyurethane condom and has not reached a consensus over how to describe them. In the effort to protect themselves, FDA officials have insisted upon labeling which recommends plastic condoms for use by only people who are allergic to latex. These labeling guidelines, finalized in November, are so restrictive that some manufacturers cannot take their products to market. Despite these current FDA obstacles to bringing a higher quality condom to the US market, industry experts and health officials hope that the polyurethane and other plastic condoms will expand the practice of safer sex, while providing an alternative method of barrier protection for the estimated 1-2 million American adults who are allergic to latex.

10-Year analysis of adverse event reports to the Food and Drug Administration for phosphodiesterase type-5 inhibitors.

PubMed

Lowe, Gregory; Costabile, Raymond A

2012-01-01

To ensure public safety all Food and Drug Administration (FDA)-approved medications undergo postapproval safety analysis. Phosphodiesterase type-5 inhibitors (PDE5-i) are generally regarded as safe and effective. We performed a nonindustry-sponsored analysis of FDA reports for sildenafil, tadalafil, and vardenafil to evaluate the reported cardiovascular and mortality events over the past 10 years. Summarized reports of adverse events (AEs) for each PDE5-i were requested from the Center for Drug Evaluation and Research within the FDA. These data are available under the Freedom of Information Act and document industry and nonindustry reports of AEs entered into the computerized system maintained by the Office of Surveillance and Epidemiology. The data were analyzed for the number of AE reports, number of objective cardiovascular events, and reported deaths. Overall, 14,818 AEs were reported for sildenafil. There were 1,824 (12.3%) reported deaths, and reports of cardiovascular AEs numbered 2,406 (16.2%). Tadalafil was associated with 5,548 AEs and 236 deaths were reported. Vardenafil was associated with 6,085 AEs and 121 reports of deaths. The percentage of reported severe cardiovascular disorders has stabilized at 10% to 15% of all AE reports for sildenafil and tadalafil and 5% to 10% for vardenafil. Only 10% of AE reports sent to the FDA for PDE5-i were from pharmaceutical manufacturers. Reports of deaths associated with PDE5-i remain around 5% of total reported events. Despite inherent limitations from evaluating FDA reports of AEs, it is important that these reports be reviewed outside pharmaceutical industry support in order to provide due diligence and transparency. Lowe G and Costabile RA. 10-year analysis of adverse event reports to the Food and Drug Administration for phosphodiesterase type-5 inhibitors. J Sex Med 2012;9:265-270. © 2011 International Society for Sexual Medicine.

How can healthcare organizations implement patient-centered care? Examining a large-scale cultural transformation.

PubMed

Bokhour, Barbara G; Fix, Gemmae M; Mueller, Nora M; Barker, Anna M; Lavela, Sherri L; Hill, Jennifer N; Solomon, Jeffrey L; Lukas, Carol VanDeusen

2018-03-07

Healthcare organizations increasingly are focused on providing care which is patient-centered rather than disease-focused. Yet little is known about how best to transform the culture of care in these organizations. We sought to understand key organizational factors for implementing patient-centered care cultural transformation through an examination of efforts in the US Department of Veterans Affairs. We conducted multi-day site visits at four US Department of Veterans Affairs medical centers designated as leaders in providing patient-centered care. We conducted qualitative semi-structured interviews with 108 employees (22 senior leaders, 42 middle managers, 37 front-line providers and 7 staff). Transcripts of audio recordings were analyzed using a priori codes based on the Consolidated Framework for Implementation Research. We used constant comparison analysis to synthesize codes into meaningful domains. Sites described actions taken to foster patient-centered care in seven domains: 1) leadership; 2) patient and family engagement; 3) staff engagement; 4) focus on innovations; 5) alignment of staff roles and priorities; 6) organizational structures and processes; 7) environment of care. Within each domain, we identified multi-faceted strategies for implementing change. These included efforts by all levels of organizational leaders who modeled patient-centered care in their interactions and fostered willingness to try novel approaches to care amongst staff. Alignment and integration of patient centered care within the organization, particularly surrounding roles, priorities and bureaucratic rules, remained major challenges. Transforming healthcare systems to focus on patient-centered care and better serve the "whole" patient is a complex endeavor. Efforts to transform healthcare culture require robust, multi-pronged efforts at all levels of the organization; leadership is only the beginning. Challenges remain for incorporating patient-centered approaches in the context of competing priorities and regulations. Through actions within each of the domains, organizations may begin to truly transform to patient-driven care.

Engineering research, development and technology report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Langland, R T

1999-02-01

Nineteen ninety-eight has been a transition year for Engineering, as we have moved from our traditional focus on thrust areas to a more focused approach with research centers. These five new centers of excellence collectively comprise Engineering's Science and Technology program. This publication summarizes our formative year under this new structure. Let me start by talking about the differences between a thrust area and a research center. The thrust area is more informal, combining an important technology with programmatic priorities. In contrast, a research center is directly linked to an Engineering core technology. It is the purer model, for itmore » is more enduring yet has the scope to be able to adapt quickly to evolving programmatic priorities. To put it another way, the mission of a thrust area was often to grow the programs in conjunction with a technology, whereas the task of a research center is to vigorously grow our core technologies. By cultivating each core technology, we in turn enable long-term growth of new programs.« less

Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS)

PubMed Central

Shimabukuro, Tom T.; Nguyen, Michael; Martin, David; DeStefano, Frank

2015-01-01

The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) conduct post-licensure vaccine safety monitoring using the Vaccine Adverse Event Reporting System (VAERS), a spontaneous (or passive) reporting system. This means that after a vaccine is approved, CDC and FDA continue to monitor safety while it is distributed in the marketplace for use by collecting and analyzing spontaneous reports of adverse events that occur in persons following vaccination. Various methods and statistical techniques are used to analyze VAERS data, which CDC and FDA use to guide further safety evaluations and inform decisions around vaccine recommendations and regulatory action. VAERS data must be interpreted with caution due to the inherent limitations of passive surveillance. VAERS is primarily a safety signal detection and hypothesis generating system. Generally, VAERS data cannot be used to determine if a vaccine caused an adverse event. VAERS data interpreted alone or out of context can lead to erroneous conclusions about cause and effect as well as the risk of adverse events occurring following vaccination. CDC makes VAERS data available to the public and readily accessible online. We describe fundamental vaccine safety concepts, provide an overview of VAERS for healthcare professionals who provide vaccinations and might want to report or better understand a vaccine adverse event, and explain how CDC and FDA analyze VAERS data. We also describe strengths and limitations, and address common misconceptions about VAERS. Information in this review will be helpful for healthcare professionals counseling patients, parents, and others on vaccine safety and benefit-risk balance of vaccination. PMID:26209838

Liver transplant center variability in accepting organ offers and its impact on patient survival

PubMed Central

Goldberg, David S.; French, Benjamin; Lewis, James D.; Scott, Frank I; Mamtani, Ronac; Gilroy, Richard; Halpern, Scott D.; Abt, Peter L

2015-01-01

Background & Aims Despite an allocation system designed to give deceased-donor livers to the sickest patients, many transplantable livers are declined by U.S. transplant centers. It is unknown whether centers vary in their propensities to decline organs for the highest-priority patients, and how these decisions directly impact patient outcomes. Methods We analyzed Organ Procurement and Transplantation Network (OPTN) data from 5/1/07-6/17/13, and included all adult liver-alone waitlist candidates offered an organ that was ultimately transplanted. We evaluated acceptance rates of liver offers for the highest-ranked patients and their subsequent waitlist mortality. Results Of the 23,740 unique organ offers, 8,882 (37.4%) were accepted for the first-ranked patient. Despite adjusting for organ quality and recipient severity of illness, transplant centers within and across geographic regions varied strikingly (p<0.001) in the percentage of organ offers they accepted for the highest-priority patients. Among all patients ranked first on waitlists, the adjusted center-specific organ acceptance rates ranged from 15.7% to 58.1%. In multivariable models, there was a 27% increased odds of waitlist mortality for every 5% absolute decrease in a center’s adjusted organ offer acceptance rate (adjusted OR: 1.27, 95% CI: 1.20–1.32). However, the absolute difference in median 5-year adjusted graft survival was 4% between livers accepted for the first-ranked patient, compared to those declined and transplanted at a lower position. Discussion There is marked variability in center practices regarding accepting livers allocated to the highest-priority patients. Center-level decisions to decline organs substantially increased patients’ odds of dying on the waitlist without a transplant. PMID:26626495

76 FR 19063 - Applications for New Awards; Educational Opportunity Centers (EOC) Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-06

... application meets this priority. This priority is: Projects that are designed to address the needs of military... other community resources in order to carry out projects that are cost-effective and best meet the needs....23). 3. Special Conditions: Under 34 CFR 74.14 and 80.12, the Secretary may impose special conditions...

Exploring end of life priorities in Saudi males: usefulness of Q-methodology.

PubMed

Hammami, Muhammad M; Al Gaai, Eman; Hammami, Safa; Attala, Sahar

2015-11-26

Quality end-of-life care depends on understanding patients' end-of-life choices. Individuals and cultures may hold end-of-life priorities at different hierarchy. Forced ranking rather than independent rating, and by-person factor analysis rather than averaging may reveal otherwise masked typologies. We explored Saudi males' forced-ranked, end-of-life priorities and dis-priorities. Respondents (n = 120) rank-ordered 47 opinion statements on end-of-life care following a 9-category symmetrical distribution. Statements' scores were analyzed by averaging analysis and factor analysis (Q-methodology). Respondents' mean age was 32.1 years (range, 18-65); 52% reported average religiosity, 88 and 83% ≥ very good health and life-quality, respectively, and 100% ≥ high school education. Averaging analysis revealed that the extreme five end-of-life priorities were to, be at peace with God, be able to say the statement of faith, maintain dignity, resolve conflicts, and have religious death rituals respected, respectively. The extreme five dis-priorities were to, die in the hospital, not receive intensive care if in coma, die at peak of life, be informed about impending death by family/friends rather than doctor, and keep medical status confidential from family/friends, respectively. Q-methodology classified 67% of respondents into five highly transcendent opinion types. Type-I (rituals-averse, family-caring, monitoring-coping, life-quality-concerned) and Type-V (rituals-apt, family-centered, neutral-coping, life-quantity-concerned) reported the lowest and highest religiosity, respectively. Type-II (rituals-apt, family-dependent, monitoring-coping, life-quantity-concerned) and Type-III (rituals-silent, self/family-neutral, avoidance-coping, life-quality & quantity-concerned) reported the best and worst life-quality, respectively. Type-I respondents were the oldest with the lowest general health, in contrast to Type-IV (rituals-apt, self-centered, monitoring-coping, life-quality/quantity-neutral). Of the extreme 14 priorities/dis-priorities for the five types, 29, 14, 14, 50, and 36%, respectively, were not among the extreme 20 priorities/dis-priorities identified by averaging analysis for the entire cohort. 1) Transcendence was the extreme end-of-life priority, and dying in the hospital was the extreme dis-priority. 2) Quality of life was conceptualized differently with less emphasize on its physiological aspects. 3) Disclosure of terminal illness to family/close friends was preferred as long it is through the patient. 4) Q-methodology identified five types of constellations of end-of-life priorities and dis-priorities that may be related to respondents' demographics and are partially masked by averaging analysis.

Shared Decision Making in the Emergency Department: Development of a Policy-Relevant Patient-Centered Research Agenda

PubMed Central

Grudzen, Corita R.; Anderson, Jana R.; Carpenter, Christopher R.; Hess, Erik P.

2016-01-01

SUMMARY SDM in emergency medicine has the potential to improve the quality, safety, and outcomes of ED patients. Given that the ED is the gateway to care for patients with a variety of illnesses and injuries, SDM in the ED is relevant to numerous healthcare disciplines. We conducted a patient-centered one-day conference to define and develop a high-priority, timely research agenda. Participants included researchers, patients, stakeholder organizations, and content experts across many areas of medicine, health policy agencies, and federal and foundation funding organizations. The results of this conference published in this issue of Academic Emergency Medicine will provide an essential summary of the future research priorities for SDM to increase quality of care and patient-centered outcomes. PMID:27396583

Realigning the Values of Academic Health Centers: The Role of Innovative Faculty Management.

ERIC Educational Resources Information Center

Arana, George W.; McCurdy, Layton

1995-01-01

The current approach to research, teaching, clinical service, and administration at academic health centers is reviewed, and the traditional values underpinning this approach are challenged. A new form of faculty management that matches the individual faculty member's priorities and skills with the health center mission and which focuses on the…

Growth of a Science Center: The Center for Science and Mathematics Education (CESAME) at Stony Brook University

ERIC Educational Resources Information Center

Gafney, Leo; Bynum, R. David; Sheppard, Keith

2015-01-01

This report describes the origin and development of CESAME (The Center for Science and Mathematics Education) at Stony Brook University. The analysis identifies key ingredients in areas of personnel, funding, organizational structures, educational priorities, collaboration, and institutionalization. After a discussion of relevant issues in…

National Biocontainment Training Center

DTIC Science & Technology

2015-02-01

develop novel diagnostic platforms to detect drug resistant TB and identification of novel antimicrobial compounds with antibacterial activity against...rCCHFV rescue work in BSL-4. Figure 6. Schematic of the CCHFV M segment fusion with Nanoluc. (a) insert the Nanoluc after the signal peptide , (b...in Dallas, Texas. Trainers: Vickie Jones and Jason Hardcastle. Food and Drug Administration (FDA-CBER) – BSL3 training was provided for faculty and

78 FR 76628 - Pilot Program for Parallel Review of Medical Products; Extension of the Duration of the Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-18

...The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) (the Agencies) are announcing the extension of the ``Pilot Program for Parallel Review of Medical Products.'' The Agencies have decided to continue the program as currently designed for an additional period of 2 years from the date of publication of this notice.

21 CFR 1271.22 - How and where do I register and submit an HCT/P list?

Code of Federal Regulations, 2011 CFR

2011-04-01

... may submit Form FDA 3356 to the Center for Biologics Evaluation and Research (HFM-775), Food and Drug... 21 Food and Drugs 8 2011-04-01 2011-04-01 false How and where do I register and submit an HCT/P list? 1271.22 Section 1271.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND...

21 CFR 207.7 - Establishment registration and product listing for human blood and blood products and for medical...

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Establishment registration and product listing for human blood and blood products and for medical devices. 207.7 Section 207.7 Food and Drugs FOOD AND DRUG... Repository Team (HFD-143), Center for Drug Evaluation and Research, FDA, and list their drug products in...

21 CFR 207.7 - Establishment registration and product listing for human blood and blood products and for medical...

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Establishment registration and product listing for human blood and blood products and for medical devices. 207.7 Section 207.7 Food and Drugs FOOD AND DRUG... Repository Team (HFD-143), Center for Drug Evaluation and Research, FDA, and list their drug products in...

21 CFR 1271.22 - How and where do I register and submit an HCT/P list?

Code of Federal Regulations, 2010 CFR

2010-04-01

... may submit Form FDA 3356 to the Center for Biologics Evaluation and Research (HFM-775), Food and Drug... 21 Food and Drugs 8 2010-04-01 2010-04-01 false How and where do I register and submit an HCT/P list? 1271.22 Section 1271.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND...

Background, Structure and Priorities of the 2013 Geneva Declaration on Person-centered Health Research

PubMed Central

Salvador-Carulla, Luis; Cloninger, C Robert; Thornicroft, Amalia; Mezzich, Juan E.

2015-01-01

Declarations are relevant tools to frame new areas in health care, to raise awareness and to facilitate knowledge-to-action. The International College on Person Centered Medicine (ICPCM) is seeking to extend the impact of the ICPCM Conference Series by producing a declaration on every main topic. The aim of this paper is to describe the development of the 2013 Geneva Declaration on Person-centered Health Research and to provide additional information on the research priority areas identified during this iterative process. There is a need for more PCM research and for the incorporation of the PCM approach into general health research. Main areas of research focus include: Conceptual, terminological, and ontological issues; research to enhance the empirical evidence of PCM main components such as PCM informed clinical communication; PCM-based diagnostic models; person-centered care and interventions; and people-centered care, research on training and curriculum development. Dissemination and implementation of PCM knowledge-base is integral to Person-centered Health Research and shall engage currently available scientific and translational dissemination tools such journals, events and eHealth. PMID:26146541

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 duration in the 2 years before and after voluntary approval or UDI action increased from 31 days (IQR = 0-339) to 217 days (IQR = 0-406; P = 0.053). The UDI was associated with higher drug prices and more frequent drug shortages when compared with the period before UDI action, while the approval process for these drugs did not necessarily require new clinical evidence to establish safety or efficacy. This project was not supported by any external grants or funds. Gupta was supported by the Yale University School of Medicine Office of Student Research at the time of this study. Dhruva is supported by the Department of Veterans Affairs as part of the Robert Wood Johnson Foundation Clinical Scholars program. Ross reports receiving research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing; from Medtronic and the FDA to develop methods for postmarket surveillance of medical devices; from the FDA to establish the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation; from the Blue Cross Blue Shield Association to better understand medical technology evidence generation; from the Centers for Medicare & Medicaid Services to develop and maintain performance measures that are used for public reporting; and from the Laura and John Arnold Foundation to support the Collaboration on Research Integrity and Transparency at Yale. Fox reports travel support from Oklahoma Society of Health System Pharmacists, Premier Oncology Hematology Management Society, and SEHA-United Arab Emirates. Vizient provides some financial support to the University of Utah Drug Information Service to provide summaries of drug shortage information. Gupta and Ross were responsible for the conception and design of this work, drafted the manuscript, and conducted the statistical analysis. Gupta and Fox were responsible for acquisition of data. Ross provided supervision. All authors participated in the analysis and interpretation of the data and critically revised the manuscript for important intellectual content.

Water-quality assessment of the Albemarle-Pamlico drainage basin, North Carolina and Virginia; trace elements in Asiatic clam (Corbicula fluminea) soft tissues and redbreast sunfish (Lepomis auritus) livers, 1992-93

USGS Publications Warehouse

Ruhl, P.M.; Smith, K.E.

1996-01-01

The analysis of potential contaminants in biological tissues is an important part of many water-quality assessment programs, including the National Water-Quality Assessment (NAWQA) Program. Tissue analyses often are used to provide information about (1) direct threats to ecosystem integrity, and (2) the occurrence and distribution of potential contaminants in the environment. During 1992-93, trace elements in Asiatic clam (Corbicula fluminea) soft tissues and redbreast sunfish (Lepomis auritus) livers were analyzed to obtain information about the occurrence and distribution of trace element contaminants in the Albemarle-Pamlico Drainage Basin of North Carolina and Virginia. The investigation was conducted as part of the NAWQA Program. All but 3 of the 22 trace elements that were analyzed were detected. Although all 10 of the U.S. Environmental Protection Agency (U.S. EPA) priority pollutants were detected in the tissues sampled, they were present in relatively low concentrations. Concentrations of U.S. EPA priority pollutants in Asiatic clams collected in the Albemarle-Pamlico Drainage Basin are similar to concentrations observed in other NAWQA study units in the southeastern United States. Mercury (a U.S. EPA priority pollutant) was widely detected, being present in 29 of 30 tissue samples, but concentrations did not exceed the FDA action level for mercury of a risk-based screening value for the general public. Mercury concentrations in Asiatic clams were similar to concentrations in other NAWQA study areas in the Southeast.

Increased risk of cardiovascular perforation during ECMO with a bicaval, wire-reinforced cannula.

PubMed

Johnson, Sidney M; Itoga, Nathan; Garnett, Gwendolyn M; Kilcommons, Melody; Puapong, Devin P; Woo, Russell K

2014-01-01

Cardiac or major vascular perforation is a rare but serious risk of ECMO. We sought to determine if perforation rates are related to cannula design. We utilized three methods to evaluate perforation on ECMO. 1. The ELSO registry was queried to establish the historical rate of hemorrhagic pericardial tamponade. 2. ELSO centers were surveyed regarding cannula related perforation events and brands of cannulas used over a four year time period (January 2008-March 2012). 3. The FDA's MAUDE database was reviewed looking for adverse events related to ECMO cannulas. The historical rate of hemorrhagic pericardial tamponade in the ELSO registry was 0.53% (~1985-2010, ELSO registry). In the survey there were eleven reports of cannula-related perforation, 0.74% (11/1482 p-value=0.29) at 7 different ELSO centers with 23 ELSO centers responding (17% response rate). The incidence of perforation was much higher for the wire-reinforced bicaval design 3.6% (10/279) as compared to catheters designed for the atrial position, 0.1% (1/1203, p-value<0.0001). Review of the FDA's MAUDE database revealed 19 adverse events related to the bicaval cannula design, 16 of which were hemorrhagic pericardial effusions or tamponade. These findings suggest a relatively high rate of cardiac perforation associated with the dual lumen bicaval cannula. This may be related to inherent differences in cannula design or the IVC positioning required by the design. © 2014.

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

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1153] Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and...: The Food and Drug Administration (FDA) is extending the comment period for the notice entitled...

A Reusable, Compliant, Small Volume Blood Reservoir for In Vitro Hemolysis Testing.

PubMed

Olia, Salim E; Herbertson, Luke H; Malinauskas, Richard A; Kameneva, Marina V

2017-02-01

Bench-top in vitro hemolysis testing is a fundamental tool during the design and regulatory safety evaluation of blood-contacting medical devices. While multiple published experimental protocols exist, descriptions of the test loop reservoir remain ambiguous. A critical fixture within the circuit, there is no readily available blood reservoir that ensures thorough mixing and complete air evacuation: two major factors which can affect results. As part of the Food and Drug Administration (FDA) Critical Path Initiative, we developed a three-piece reservoir consisting of a 3D-printed base, a plastic clamp set, and a medical-grade blood bag. This simple, reusable, and cost-effective design was used successfully in the hemolysis assessment of FDA benchmark nozzles and prototype rotary blood pumps, and may be useful as an integral component to any in vitro blood circulation loop. © 2016 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

Thalidomide and the Titanic: reconstructing the technology tragedies of the twentieth century.

PubMed Central

Annas, G J; Elias, S

1999-01-01

The Titanic has become a metaphor for the disastrous consequences of an unqualified belief in the safety and invincibility of new technology. Similarly, the thalidomide tragedy stands for all of the "monsters" that can be inadvertently or negligently created by modern medicine. Thalidomide, once banned, has returned to the center of controversy with the Food and Drug Administration's (FDA's) announcement that thalidomide will be placed on the market for the treatment of erythema nodosum leprosum, a severe dermatological complication of Hansen's disease. Although this indication is very restricted, thalidomide will be available for off-label uses once it is on the market. New laws regarding abortion and a new technology, ultrasound, make reasonable the approval of thalidomide for patients who suffer from serious conditions it can alleviate. In addition, the FDA and the manufacturer have proposed the most stringent postmarketing monitoring ever used for a prescription drug, including counseling, contraception, and ultrasonography in the event of pregnancy. The Titanic/thalidomide lesson for the FDA and public health is that rules and guidelines alone are not sufficient to guarantee safety. Continuous vigilance will be required to ensure that all reasonable postmarketing monitoring steps are actually taken to avoid predictable and preventable teratogenic disasters. PMID:9987477

Provider experiences with negative-pressure wound therapy systems.

PubMed

Kaufman-Rivi, Diana; Hazlett, Antoinette C; Hardy, Mary Anne; Smith, Jacquelyn M; Seid, Heather B

2013-07-01

MedWatch, the Food and Drug Administration's (FDA's) nationwide adverse event reporting system, serves to monitor device performance after a medical device is approved or cleared for market. Through the MedWatch adverse event reporting system, the FDA receives Medical Device Reports of deaths and serious injuries with negative-pressure wound therapy (NPWT) systems, many of which are used in homes and in extended-care facilities. In response to reported events, this study was conducted to obtain additional information about device issues that healthcare professionals face in these settings, as well as challenges that caregivers might encounter using this technology at home. The study was exploratory and descriptive in nature. The FDA surveyed wound care specialists and professional home healthcare providers to learn about users' experiences with NPWT. In the first phase of the study, a semistructured questionnaire was developed for telephone interviews and self-administration. In the second phase, a web-based survey was adapted from the semistructured instrument. Respondent concerns primarily centered on issues not directly related to the NPWT devices: NPWT prescription, provider education in addition to patient training and appropriate wound management practices, notably ongoing wound assessment, and patient monitoring. Overall, respondents thought that there was a definite benefit to NPWT, regardless of the care setting, and that it was a safe therapy when prescribed and administered appropriately.

Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing evaluation: Rationale and best practices. A report from the cardiac safety research consortium.

PubMed

Seltzer, Jonathan H; Heise, Ted; Carson, Peter; Canos, Daniel; Hiatt, Jo Carol; Vranckx, Pascal; Christen, Thomas; Cutlip, Donald E

2017-08-01

This white paper provides a summary of presentations, discussions and conclusions of a Thinktank entitled "The Role of Endpoint Adjudication in Medical Device Clinical Trials". The think tank was cosponsored by the Cardiac Safety Research Committee, MDEpiNet and the US Food and Drug Administration (FDA) and was convened at the FDA's White Oak headquarters on March 11, 2016. Attention was focused on tailoring best practices for evaluation of endpoints in medical device clinical trials, practical issues in endpoint adjudication of therapeutic, diagnostic, biomarker and drug-device combinations, and the role of adjudication in regulatory and reimbursement issues throughout the device lifecycle. Attendees included representatives from medical device companies, the FDA, Centers for Medicare and Medicaid Services (CMS), end point adjudication specialist groups, clinical research organizations, and active, academically based adjudicators. The manuscript presents recommendations from the think tank regarding (1) rationale for when adjudication is appropriate, (2) best practices establishment and operation of a medical device adjudication committee and (3) the role of endpoint adjudication for post market evaluation in the emerging era of real world evidence. Copyright © 2017. Published by Elsevier Inc.

Policy and Practice-Relevant Youth Physical Activity Research Center Agenda.

PubMed

Botchwey, Nisha; Floyd, Myron F; Pollack Porter, Keshia; Cutter, Carmen L; Spoon, Chad; Schmid, Tom L; Conway, Terry L; Hipp, J Aaron; Kim, Anna J; Umstattd Meyer, M Renee; Walker, Amanda L; Kauh, Tina J; Sallis, Jim F

2018-06-08

The Physical Activity Research Center developed a research agenda that addresses youth physical activity (PA) and healthy weight, and aligns with the Robert Wood Johnson Foundation's Culture of Health. This paper summarizes prioritized research studies with a focus on youth at higher risk for inactive lifestyles and childhood obesity in urban and rural communities. Systematic literature reviews, a survey, and discussions with practitioners and researchers provided guidance on research questions to build evidence and inform effective strategies to promote healthy weight and PA in youth across race, cultural, and economic groups. The research team developed a matrix of potential research questions, identified priority questions, and designed targeted studies to address some of the priority questions and inform advocacy efforts. The studies selected examine strategies advocating for activity-friendly communities, Play Streets, park use, and PA of youth in the summer. A broader set of research priorities for youth PA is proposed. Establishing the Physical Activity Research Center research agenda identified important initial and future research studies to promote and ensure healthy weight and healthy levels of PA for at-risk youth. Results will be disseminated with the goal of promoting equitable access to PA for youth.

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

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2002-D-0094; (formerly Docket No. 02D-0049)] Guidance for the Public, Food and Drug Administration (FDA) Advisory... Food and Drug Administration (FDA) is announcing the availability of a guidance for the public, FDA...

78 FR 950 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-07

..., FDA- 2012-M-0965, FDA-2012-M-0968, FDA-2012-M-1011, and FDA-2012-M-1013] Medical Devices; Availability...\\ February 16, 2011. Adjustable Gastric Banding System. P100049, FDA-2012-M-0893....... Torax Medical, Inc.... Trabecular Micro- Bypass Stent and Inserter. P110007, FDA-2012-M-0734....... Abbott Medical Healon[supreg...

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

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2005-D-0072] (formerly Docket No. 2005D-0042) Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings; Availability AGENCY: Food and Drug...

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

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1153] Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and... information. SUMMARY: In September 2011, the Food and Drug Administration (FDA or the Agency) asked the...

The Ebola Spatial Care Path™: Accelerating point-of-care diagnosis, decision making, and community resilience in outbreaks.

PubMed

Kost, Gerald J; Ferguson, William J; Hoe, Jackie; Truong, Anh-Thu; Banpavichit, Arirat; Kongpila, Surin

2015-01-01

To present a vision where point-of-care testing (POCT) accelerates an Ebola Spatial Care Path™ (SCP) and future molecular diagnostics enable facilitated-access self-testing (FAST POC); to design an alternate care facility (ACF) for the SCP; to innovate an Ebola diagnostic center (DC); and to propel rapid POCT to the frontline to create resilience that stops future outbreaks. PubMed, literature, and web searches. Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Medicine Without Frontiers, and World Health Organization (WHO) document analyses. Investigations in China, the Philippines, Thailand, and the United States. Review of SE Asia, US, and West Africa isolation-treatment centers. Innovation of a SCP, ACF, and DC suitable for American and other communities. The authors designed an ACF and DC to integrate SCP principles for urgent Ebola care. FDA emergency use authorizations for Ebola molecular diagnostics were discovered, but no portable, handheld, or self-contained molecular POC instruments are yet available, although feasible. The WHO initiated design criteria and an acceptance protocol for testing. Financial investment in POCT will downsize Ebola outbreaks. POCT is facilitating global health. Now, global health problems are elevating POCT to new levels of importance for accelerating diagnosis and evidence-based decision making during disease outbreaks. Authorities concur that rapid diagnosis has potential to stop disease spread. With embedded POCT, strategic SCPs planned by communities fulfill CDC recommendations. POC devices should consolidate multiplex test clusters supporting patients with Ebola in isolation. The ultimate future solution is FAST POC. New technologies offer minimally significant risks. Diagnostic centers in ACFs and transportable formats also will optimize Ebola SCPs.

Advancing Deeper Learning under ESSA: Seven Priorities. Turning the Corner Post-Conference Brief. Students at the Center

ERIC Educational Resources Information Center

Heller, Rafael; Gerwin, Carol

2016-01-01

This brief recommends seven ways for supporters of deeper learning to take advantage of the changing education policy landscape, as authority shifts from the federal government to states and local districts. The authors outline priorities to help the nation's high schools move from a largely inequitable system to one that prepares all students for…

The Vital Role of Patient Feedback in the Critical Assessment of a Patient-Centered Care Objective Structured Clinical Examination

ERIC Educational Resources Information Center

Rentfro, Allison Carothers

2011-01-01

Priorities in medical education have increasingly emphasized teaching skills and fostering attitudes related to patient-centered care (Beckman & Frankel, 2003; Haidet & Paterniti, 2003). The challenge for academic medical centers is to implement these competencies into their curriculum and assess the outcomes. Using a qualitative single…

Accelerating drug development and approval.

PubMed

Cole, Patrick

2010-01-01

Regulatory agencies are the gateway between the pharma/biotech industry and patients and can serve as stimulators of new drug development. This article highlights several means of doing so implemented thus far, many with already impressive histories, such as orphan drug legislation, and others of a more experimental nature, such as the FDA's priority review voucher program. These initiatives represent different approaches to finding treatments for rare and widespread but neglected diseases, as well as speeding the development process for pharmaceutical and biological agents more generally. Commercial incentives, streamlined regulatory processing, exploratory trial designs, research assistance and cash infusions are all means of promoting drug development being explored in the United States, Europe and beyond. In some cases, such as fast track designation and priority review vouchers, regulatory agencies have turned their own processes into incentives, offering advantageous alternative routes to product approval, like a faster lane on the highway for vehicles carrying multiple passengers. In 2009, regulatory agencies and the governments they represent also had to confront two tremendous challenges: the global recession and the H1N1 influenza virus pandemic. These tests have been met with increased funding in the former case and coordinated efforts to develop, approve and stockpile H1N1 vaccines in the latter.

Perceptions of the Food and Drug Administration as a Tobacco Regulator

PubMed Central

Jarman, Kristen L.; Ranney, Leah M.; Baker, Hannah M.; Vallejos, Quirina M.; Goldstein, Adam O.

2017-01-01

Objectives The U. S. Food and Drug Administration (FDA) now has regulatory authority over all tobacco products. Little is known about public awareness and perceptions of FDA in their new role as a tobacco regulator. This research utilizes focus groups to examine perceptions of FDA as a tobacco regulator so that FDA can better communicate with the public about this role. Methods We conducted 6 focus groups in 2014 among a diverse sample of smokers and non-smokers. Participants were asked if they had heard of FDA, what they knew about FDA, if they associated FDA with tobacco, and their thoughts about this FDA role. Results A total of 41 individuals participated. Although nearly all participants had heard of FDA, most were not aware of FDA’s regulatory authority over tobacco products, did not associate the role of FDA with tobacco, and some drew comparisons between FDA’s work in tobacco and their work regulating food and drugs. Conclusion Data suggest that although public awareness of FDA regulatory authority over tobacco is low, with proper public education, the public may find FDA to be a trustworthy source of tobacco regulation. PMID:29051917

78 FR 29237 - Final Priority; National Institute on Disability and Rehabilitation Research-Rehabilitation...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-20

..., producing observational findings, and creating other sources of research-based information. This research... Institute on Disability and Rehabilitation Research--Rehabilitation Research and Training Centers AGENCY... for the Disability and Rehabilitation Research Projects and Centers Program administered by the...

78 FR 14947 - Proposed Priorities-National Institute on Disability and Rehabilitation Research-Disability and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-08

...-the-science conferences, webinars, Web sites, and other dissemination methods; and Coordinate research... and Rehabilitation Research--Disability and Rehabilitation Research Projects and Centers Program--Rehabilitation Engineering Research Centers AGENCY: Office of Special Education and Rehabilitative Services...

Meloquine Use and Hospitalizations Among US Service Members, 2002-2004

DTIC Science & Technology

2005-04-12

name Lariam, was approved by the Food and Drug Administration on May 2, 1989, for malaria chemoprophylaxis.6 In 1990, the Centers for Disease...2005;293(2):212-216. 6. Food and Drug Administration. Approval history, Lariam. Available at: http://www.accessdata.fda.gov/scripts/cder...163-165. 26. Jimeniz-Huete A, Gil-Nagel A, Franch O. Multifocal myoclonus associated with mefloquine prophylaxis [letter]. Clin Neuropharmacol

Avelumab: First Global Approval.

PubMed

Kim, Esther S

2017-05-01

Avelumab (Bavencio ® ) is an intravenously administered programmed cell death ligand-1-blocking human antibody initially developed by EMD Serono Inc. (the biopharmaceutical division of Merck KGaA, Darmstadt, Germany) [now jointly developed and commercialized by EMD Serono Inc. and Pfizer] for the treatment of various tumours. It has received accelerated approval in the USA for the treatment of metastatic Merkel cell carcinoma (mMCC) in adults and paediatric patients aged ≥12 years. The marketing authorization application for avelumab in the treatment of mMCC is undergoing regulatory review in the EU, the biologics license application for avelumab in the treatment of urothelial carcinoma is undergoing priority review by the FDA, and avelumab is in various stages of development internationally for a variety of cancers. This article summarizes the milestones in the development of avelumab leading to this first approval for mMCC.

Implementing Effective Substance Abuse Treatments in General Medical Settings: Mapping the Research Terrain

PubMed Central

Ducharme, Lori J.; Chandler, Redonna K.; Harris, Alex H. S.

2015-01-01

The National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA), and Veterans Health Administration (VHA) share an interest in promoting high quality, rigorous health services research to improve the availability and utilization of evidence-based treatment for substance use disorders (SUD). Recent and continuing changes in the healthcare policy and funding environments prioritize the integration of evidence-based substance abuse treatments into primary care and general medical settings. This area is a prime candidate for implementation research. Recent and ongoing implementation projects funded by these agencies are reviewed. Research in five areas is highlighted: screening and brief intervention for risky drinking; screening and brief intervention for tobacco use; uptake of FDA-approved addiction pharmacotherapies; safe opioid prescribing; and disease management. Gaps in the portfolios, and priorities for future research, are described. PMID:26233697

Association of Attorney Advertising and FDA Action with Prescription Claims: A Time Series Segmented Regression Analysis.

PubMed

Tippett, Elizabeth C; Chen, Brian K

2015-12-01

Attorneys sponsor television advertisements that include repeated warnings about adverse drug events to solicit consumers for lawsuits against drug manufacturers. The relationship between such advertising, safety actions by the US Food and Drug Administration (FDA), and healthcare use is unknown. To investigate the relationship between attorney advertising, FDA actions, and prescription drug claims. The study examined total users per month and prescription rates for seven drugs with substantial attorney advertising volume and FDA or other safety interventions during 2009. Segmented regression analysis was used to detect pre-intervention trends, post-intervention level changes, and changes in post-intervention trends relative to the pre-intervention trends in the use of these seven drugs, using advertising volume, media hits, and the number of Medicare enrollees as covariates. Data for these variables were obtained from the Center for Medicare and Medicaid Services, Kantar Media, and LexisNexis. Several types of safety actions were associated with reductions in drug users and/or prescription rates, particularly for fentanyl, varenicline, and paroxetine. In most cases, attorney advertising volume rose in conjunction with major safety actions. Attorney advertising volume was positively correlated with prescription rates in five of seven drugs, likely because advertising volume began rising before safety actions, when prescription rates were still increasing. On the other hand, attorney advertising had mixed associations with the number of users per month. Regulatory and safety actions likely reduced the number of users and/or prescription rates for some drugs. Attorneys may have strategically chosen to begin advertising adverse drug events prior to major safety actions, but we found little evidence that attorney advertising reduced drug use. Further research is needed to better understand how consumers and physicians respond to attorney advertising.

Understanding how perceptions of tobacco constituents and the FDA relate to effective and credible tobacco risk messaging: A national phone survey of U.S. adults, 2014-2015.

PubMed

Boynton, Marcella H; Agans, Robert P; Bowling, J Michael; Brewer, Noel T; Sutfin, Erin L; Goldstein, Adam O; Noar, Seth M; Ribisl, Kurt M

2016-06-23

The passage of the 2009 Family Smoking Prevention and Tobacco Control Act has necessitated the execution of timely, innovative, and policy-relevant tobacco control research to inform Food and Drug Administration (FDA) regulatory and messaging efforts. With recent dramatic changes to tobacco product availability and patterns of use, nationally representative data on tobacco-related perceptions and behaviors are vital, especially for vulnerable populations. The UNC Center for Regulatory Research on Tobacco Communication conducted a telephone survey with a national sample of adults ages 18 and older living in the United States (U.S.). The survey assessed regulatory relevant factors such as tobacco product use, tobacco constituent perceptions, and tobacco regulatory agency credibility. The study oversampled high smoking/low income areas as well as cell phone numbers to ensure adequate representation among smokers and young adults, respectively. Coverage extended to approximately 98 % of U.S. households. The final dataset (N = 5,014) generated weighted estimates that were largely comparable to other national demographic and tobacco use estimates. Results revealed that over one quarter of U.S. adults, and over one third of smokers, reported having looked for information about tobacco constituents in cigarette smoke; however, the vast majority was unaware of what constituents might actually be present. Although only a minority of people reported trust in the federal government, two thirds felt that the FDA can effectively regulate tobacco products. As the FDA continues their regulatory and messaging activities, they should expand both the breadth and availability of constituent-related information, targeting these efforts to reach all segments of the U.S. population, especially those disproportionately vulnerable to tobacco product use and its associated negative health outcomes.

78 FR 34261 - Final Priority-National Institute on Disability and Rehabilitation Research-Rehabilitation...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-07

..., such as observational research or research toward the development of diagnostic or outcome assessment... Institute on Disability and Rehabilitation Research--Rehabilitation Research and Training Centers AGENCY... for the Disability and Rehabilitation Research Projects and Centers Program administered by the...

76 FR 33734 - Applications for New Awards; Spinal Cord Injury Model Systems (SCIMS) Centers and SCIMS Multi...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-09

... Institute on Disability and Rehabilitation Research (NIDRR)-- Disability and Rehabilitation Research Projects and Centers Program-- Disability and Rehabilitation Research Projects (DRRPs) and Special Projects... Research Projects. General Disability and Rehabilitation Research Projects (DRRP) Requirements priority...

78 FR 29234 - Final Priority; National Institute on Disability and Rehabilitation Research-Disability and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-20

... Institute on Disability and Rehabilitation Research--Disability and Rehabilitation Research Projects and... Center (RRTC) on Disability Statistics and Demographics under the Disability and Rehabilitation Research Projects and Centers program administered by the National Institute on Disability and Rehabilitation...

Adding Only One Priority Rule Allows Extending CIP Rules to Supramolecular Systems.

PubMed

Alkorta, Ibon; Elguero, José; Cintas, Pedro

2015-05-01

There are frequent situations both in supramolecular chemistry and in crystallography that result in stereogenic centers, whose absolute configuration needs to be specified. With this aim we propose the inclusion of one simple additional rule to the Cahn-Ingold-Prelog (CIP) system of priority rules stating that noncovalent interactions have a fictitious number between 0 and 1. © 2015 Wiley Periodicals, Inc.

78 FR 7831 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-04

... on the book solely for the purpose of modifying the marking of a sell order as long, short, or short... not affect the priority of the order on the book. Except as provided in Rule 4761, all other... size of the order) does not cause the order to lose priority on the NASDAQ Market Center book. NASDAQ...

Application of the biosafety RAM and eProtocol software programs to streamline institutional biosafety committee processes at the USDA-National Animal Disease Center

USDA-ARS?s Scientific Manuscript database

The National Animal Disease Center (NADC) conducts basic and applied research on endemic animal diseases of high priority that adversely affect U.S. livestock production or trade. Experiments conducted at this Center vary in range and scope, with a subset involving synthetic or recombinant nucleic a...

21 CFR 314.102 - Communications between FDA and applicants.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a) General...

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... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or park...

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... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or park...

21 CFR 314.102 - Communications between FDA and applicants.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a) General...

FDA Kids' Home Page

MedlinePlus

... and Drug Administration A to Z Index Follow FDA En Español Search FDA Submit search Popular Content Home Food Drugs Medical ... 日本語 | فارسی | English FDA Accessibility Careers FDA Basics FOIA No FEAR Act ...

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... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or park...

21 CFR 314.102 - Communications between FDA and applicants.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a) General...

21 CFR 314.102 - Communications between FDA and applicants.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a) General...

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... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or park...

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... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or park...

21 CFR 314.102 - Communications between FDA and applicants.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a) General...

Comparison and alignment of an academic medical center's strategic goals with ASHP initiatives.

PubMed

Engels, Melanie J; Chaffee, Bruce W; Clark, John S

2015-12-01

An academic medical center's strategic goals were compared and aligned with the 2015 ASHP Health-System Pharmacy Initiative and the Pharmacy Practice Model Initiative (PPMI). The department's pharmacy practice model steering committee identified potential solutions to narrow prioritized gaps using a modified nominal group technique and a multivoting dot technique. Five priority solutions were identified and assigned to work groups to develop business plans, which included admission medication history and reconciliation for high-risk patients and those with complex medication regimens, pharmacist provision of discharge counseling to high-risk patients and those with complex medication regimens, improved measurement and reporting of the impact of PPMI programs on patient outcomes, implementation of a departmentwide formalized peer review and evaluation process, and the greeting of every patient at some time during his or her visit by a pharmacy team member. Stakeholders evaluated the business plans based on feasibility, financial return on investment, and anticipated safety enhancements. The solution that received the highest priority ranking and was subsequently implemented was "improved measurement and reporting of the impact of PPMI programs on patient outcomes." A defined process was followed for identifying gaps among current practices at an academic medical center and the 2015 ASHP Health-System Pharmacy Initiative and the PPMI. A key priority to better document the impact of pharmacists on patient care was identified for our department by using a nominal group technique brainstorming process and a multivoting dot technique and creating standardized business plans for five potential priority projects. Copyright © 2015 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

76 FR 62070 - Proposed Data Collections Submitted for Public Comment and Recommendations

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-06

... priority areas: Breast and cervical cancer; cardiovascular disease; diabetes mellitus; adult/older adult... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-11-0805... on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will...

EPA Science to Achieve Results (STAR) Centers for Water Research on National Priorities Related to a Systems View of Nutrient Management

EPA Science Inventory

This poster describes the missions and objectives of four newly-awarded Science to Achieve Results (STAR) Centers. There is also a description of how the projects fit together to meet solicitation research questions.

77 FR 35410 - Fogarty International Center 2013 Strategic Plan

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-13

... needs. The Fogarty International Center supports basic, clinical and applied research and training for U...) is updating its strategic plan. To anticipate and set priorities for global health research and research training, FIC requests input from scientists, the general public, and interested parties. The goal...

AIR POLLUTION MIXTURES: HEALTH EFFECTS ACROSS LIFE STAGES

EPA Science Inventory

Our Center will address four of the six research priorities of the EPA solicitation to establish Clean Air Centers. It will: I) investigate the effects of pollutants and mixtures through animal and human studies; 2) identify sub-populations that are at increased risk through t...

Atlantic salmon and eastern oyster breeding programs at the National Cold Water Marine Aquaculture Center

USDA-ARS?s Scientific Manuscript database

The USDA-ARS National Cold Water Marine Aquaculture Center (NCWMAC) focuses on the coldwater marine aquaculture industry's highest priority research needs including development of improved genetic stocks. Coldwater aquaculture production has potential for expansion, and both Atlantic salmon and East...

A Guide to the Data Resources of the Henry A. Murray Research Center of Radcliffe College: A Center for the Study of Lives [and] Index to [the] Guide.

ERIC Educational Resources Information Center

Radcliffe Coll., Cambridge, MA. Henry A. Murray Research Center.

The first of two volumes provides information about data resources available at the Henry A. Murray Research Center of Radcliffe College, a multidisciplinary research center that is a national repository for social and behavioral science data on human development and social change; topics of special concern to women are collection priorities. The…

21 CFR 1.280 - How must you submit prior notice?

Code of Federal Regulations, 2010 CFR

2010-04-01

... to FDA. You must submit all prior notice information in the English language, except that an... Commercial System (ABI/ACS); or (2) The FDA PNSI at http://www.access.fda.gov. You must submit prior notice through the FDA Prior Notice System Interface (FDA PNSI) for articles of food imported or offered for...

78 FR 65329 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-31

... Safety Testing of Sunlamp Products'' Form FDA 3632 ``Guide for Preparing Product Reports on Lasers and Products Containing Lasers'' Form FDA 3633''General Variance Request'' Form FDA 3634 ``Television Products Annual Report'' Form FDA 3635 ``Laser Light Show Notification'' Form FDA 3636 ``Guide for Preparing...

78 FR 35279 - Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Products

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-12

... Lasers and Products Containing Lasers'' FDA Form 3633 ``General Variance Request'' FDA Form 3634 ``Television Products Annual Report'' FDA Form 3635 ``Laser Light Show Notification'' FDA Form 3636 ``Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products'' FDA Form 3637...

75 FR 26964 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-13

... of Sunlamps and Sunlamp Products'' FDA Form 3632 ``Guide for Preparing Product Reports on Lasers and Products Containing Lasers'' FDA Form 3633 ``General Variance Request'' FDA Form 3634 ``Television Products Annual Report'' FDA Form 3635 ``Laser Light Show Notification'' FDA Form 3636 ``Guide for Preparing...

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) Experimental...

21 CFR 314.106 - Foreign data.

Code of Federal Regulations, 2012 CFR

2012-04-01

... USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA is able to validate the data through an on-site inspection or other appropriate means. Failure of...

21 CFR 314.106 - Foreign data.

Code of Federal Regulations, 2013 CFR

2013-04-01

... USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA is able to validate the data through an on-site inspection or other appropriate means. Failure of...

42 CFR 405.203 - FDA categorization of investigational devices.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 2 2014-10-01 2014-10-01 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) Experimental...

21 CFR 314.106 - Foreign data.

Code of Federal Regulations, 2010 CFR

2010-04-01

... USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA is able to validate the data through an on-site inspection or other appropriate means. Failure of...

42 CFR 405.203 - FDA categorization of investigational devices.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 2 2013-10-01 2013-10-01 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) Experimental...