Science.gov

Sample records for administration fda requires

  1. 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

    ...In September 2011, the Food and Drug Administration (FDA or the Agency) asked the Institute of Food Technologists (IFT) to execute product tracing pilot projects as described in the FDA Food Safety Modernization Act (FSMA). FDA recently released a report from IFT on these pilot projects, entitled ``Pilot Projects for Improving Product Tracing along the Food Supply System.'' FDA is announcing......

  2. Medical device data systems and FDA regulation. Should medical device data systems require FDA clearance?

    PubMed

    Kelley, Peter

    2010-01-01

    It is widely understood why medical devices need to be regulated by the FDA and other governing bodies. However medical software does not typically require the same level of regulation. Currently the FDA is investigating whether one type of medical software, Medical Device Data Systems (MDDS), should require FDA clearance because of the potential risk they impose when interconnected with medical devices. Hospitals are looking to implement MDDS because the technology allows nursing staff to spend more time on direct patient care and reduces charting errors. This article will explore the FDA's proposal and will review the possible risks and provide a rationale for why MDDS should be regulated by the FDA and why MDDS vendors should have the right level of quality and risk management procedures in place to ensure that they are developing and bringing to market the safest products possible. PMID:20677470

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

    ... and Tracing of Food'' that appeared in the Federal Register of March 5, 2013 (78 FR 14309). In the... Register of March 5, 2013 (78 FR 14309), FDA published a ] notice with a 30-day comment period to...

  4. Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies

    PubMed Central

    2013-01-01

    : Clinton (122.3 ± 36.4), Bush (29.5 ± 16.2) and Obama (41.7 ± 11.1). Conclusions Most regulatory letters released by FDA headquarters were related to marketing and advertising activities of pharmaceutical companies. The number of regulatory letters was highest during the second Clinton administration, diminished during the Bush administrations, and increased again during the Obama administration. A further assessment of the impact of changes in federal administration on the enforcement activities of the FDA is required. PMID:23339419

  5. FDA's requirements for in-vivo performance data for prosthetic heart valves.

    PubMed

    Johnson, D M; Sapirstein, W

    1994-07-01

    The Food and Drug Administration (FDA) has recently revised its "Replacement Heart Valve Guidance". That document lists the data FDA deems necessary to support the approval of new prosthetic heart valves of all designs, and which should be contained in Premarket Approval Applications for these devices. The guidance covers detailed data requirements for in vitro, animal, and clinical data. This paper is intended to briefly summarize FDA's requirements for in vivo and clinical data. The clinical study must establish that the device is both safe and effective, as compared to currently marketed replacement heart valves. It is possible to achieve this goal using hypothesis testing to compare the results of an observational study against a set of Objective Performance Criteria (OPC) which have been established by the FDA. The establishment of the OPCs was facilitated by a standardized set of definitions of complications published by the American Association of Thoracic Surgery and Society of Thoracic Surgeons (AATS/STS) in 1987/1988. Papers published in peer reviewed journals have utilized this set of definitions for data analysis, providing an ample pool of data from which to establish OPCs. The number of patients required to establish the safety and efficacy of a replacement heart valve, using this approach, is 800 valve years, 400 in the aortic and 400 in the mitral position. Advantages of this approach are reduction in the number of patients and duration of the study. PMID:7952304

  6. Safe Medical Devices Act: management guidance for hospital compliance with the new FDA requirements.

    PubMed

    Alder, H C

    1993-10-01

    The Safe Medical Devices Act of 1990 (Public Law 101-629) was signed by President George Bush almost three years ago on November 28, 1990. The law expanded the Food and Drug Administration's (FDA) authority to regulate medical devices and grew out of congressional concerns about the FDA's ability to quickly learn when a medical device caused an adverse patient event, and to ensure that hazardous devices are removed from hospitals and other health care facilities in a timely manner. The Safe Medical Devices Act is an extension of the Medical Device Amendments of 1976, which imposed production, distribution, and sales rules on medical device manufacturers. It gives the FDA the legal authority to directly regulate the use of medical devices in health care facilities. Among the Safe Medical Devices Act's provisions are specific requirements for hospitals, health professionals, and other users of medical devices to report patient incidents involving medical devices to the manufacturer and to the FDA if a device caused or contributed to a serious injury, death, or other "adverse experience." Adverse experiences are defined by the FDA to include concussions, fractures, burns, temporary paralysis, and temporary loss of sight, hearing, or smell. Hospitals have been required to comply with this provision of the law, called user reporting, since 1991. Hospitals are also required to participate in tracking certain medical devices whose failure could result in a serious adverse health outcome. The law requires distributors and manufacturers of specific devices to adopt a method for device tracking. Hospitals are required to cooperate with and provide device manufacturers with information about patients with permanently implantable devices and life-sustaining and life-supporting devices used outside device user facilities. The law also gives the FDA the authority to designate other devices subject to tracking if the agency determines such tracking is warranted to preserve the

  7. Radiation recommendation series: administratively required dental radiographs

    SciTech Connect

    Not Available

    1981-09-01

    Administrative requirements for radiographs are found in many segments of the United States health care system. This document presents an FDA radiation recommendation on administratively required dental x-ray examinations. In general, such examinations are not requested to further the patient's dental health, but rather as a means of monitoring claims. However, the administrative use of radiographs that have been taken in the normal course of patient care is usually appropriate, as long as the patient's right to privacy is respected.

  8. 10 CFR 35.7 - FDA, other Federal, and State requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false FDA, other Federal, and State requirements. 35.7 Section 35.7 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Information § 35.7 FDA, other Federal, and State requirements. Nothing in this part relieves the licensee...

  9. NCL Partnerships - U.S. Food and Drug Administration (FDA)- Nanotechnology Characterization Laboratory

    Cancer.gov

    The activities within the NCL represent a formal scientific interaction of three Federal agencies: National Cancer Institute and U.S. Food and Drug Administration (FDA) of the Department of Health and Human Services, and National Institute of Standards and Technology (NIST) of the Department of Commerce.

  10. 76 FR 17138 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-28

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... public workshop on FDA's clinical trial requirements is designed to aid the clinical research... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  11. 76 FR 78933 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-20

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... workshop. The public workshop on FDA's clinical trial requirements is designed to aid the clinical research... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  12. 75 FR 51824 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-23

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... workshop. The public workshop on FDA's clinical trial requirements is designed to aid the clinical research... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  13. 77 FR 49448 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-16

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... public workshop on FDA's clinical trial requirements is designed to aid the clinical research... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  14. 76 FR 51040 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... workshop. The public workshop on FDA's clinical trial requirements is designed to aid the clinical research... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  15. 77 FR 8886 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... public workshop on FDA's clinical trial requirements is designed to aid the clinical research... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  16. The debate on FDA reform: a view from the U.S. Senate. Food and Drug Administration.

    PubMed

    Baker, R

    1995-09-01

    The recently released concept paper on Food and Drug Administration (FDA) reform from Republican Senator, Nancy Kassebaum, is reviewed. Senator Kassebaum chairs the Senate Committee on Labor and Human Resources that will influence the Senate's action on FDA reform. The paper outlines the Senator's priorities for Congressional legislation on FDA reform in the following areas: the FDA mission and its accountability; creation of a Performance Review Panel and Industry Advisory Council; approval and access of products for seriously ill patients; the FDA's responsibility for good manufacturing practices; establishment of an Ombudsman Office for resolving disputes; dissemination of information on unapproved uses of approved products; and approval standards for new drugs. PMID:11362892

  17. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food and Drug Administration's (FDA's... 21 Food and Drugs 3 2014-04-01 2014-04-01 false The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective....

  18. 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

    .... 02D-0049, now Docket No. FDA- 2002-D-0094, 67 FR 6545, February 12, 2002). The draft guidance was... comment (72 FR 61657, October 31, 2007). The Agency reviewed the submitted comments on the January 2002..., and increased the consistency and clarity of the process (73 FR 45459, August 5, 2008) (...

  19. 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. PMID:23269527

  20. Proton-pump inhibitors in patients requiring antiplatelet therapy: new FDA labeling.

    PubMed

    Johnson, David A; Chilton, Robert; Liker, Harley R

    2014-05-01

    Proton-pump inhibitors (PPIs) are recommended for patients who require antiplatelet therapy and have a history of upper gastrointestinal bleeding. Proton-pump inhibitors should also be considered for patients receiving antiplatelet therapy who have other risk factors for gastrointestinal bleeding, including use of aspirin. Thus, evidence of pharmacokinetic and pharmacodynamic interactions between PPIs and consequent impaired effectiveness of the antiplatelet agent clopidogrel has caused concern. Here, we discuss comparative studies suggesting that the extent to which a PPI reduces exposure to the active metabolite of clopidogrel and attenuates its antithrombotic effect differs among PPIs. Although a clinically meaningful effect of the interaction between PPIs and clopidogrel on cardiovascular outcomes has not been established, these studies provided the basis for recent changes in US Food and Drug Administration (FDA) labeling for several PPIs and clopidogrel. New labeling suggests that PPI use among patients taking clopidogrel be limited to pantoprazole, rabeprazole, lansoprazole, or dexlansoprazole. Because comparative studies indicate that omeprazole and esomeprazole have a greater effect on the CYP2C19-mediated conversion of clopidogrel to its active metabolite and, consequently, clopidogrel's effect on platelet reactivity, FDA labeling recommends avoiding omeprazole and esomeprazole in patients taking clopidogrel. Even a 12-hour separation of dosing does not appear to prevent drug interactions between omeprazole and clopidogrel. PMID:24918808

  1. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 3 2010-04-01 2009-04-01 true The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective. 170.105 Section 170.105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION...

  2. 77 FR 49449 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-16

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... announcing a public workshop. The public workshop on FDA's clinical trial requirements is designed to aid the... FDA and clinical trial staff, investigators, and institutional review boards (IRBs). Individual...

  3. 75 FR 14448 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-25

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... announcing a public workshop entitled ``FDA Clinical Trial Requirements, Regulations, Compliance, and Good... representatives. The program will focus on the relationships among the FDA and clinical trial staff,...

  4. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food... 21 Food and Drugs 3 2012-04-01 2012-04-01 false The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective....

  5. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food... 21 Food and Drugs 3 2011-04-01 2011-04-01 false The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective....

  6. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food... 21 Food and Drugs 3 2013-04-01 2013-04-01 false The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective....

  7. Is It Really FDA Approved?

    MedlinePlus

    ... and implantable infusion pumps, require FDA approval before marketing. To receive FDA approval for these devices, the ... and many types of catheters) are cleared for marketing based on an FDA determination that they are ...

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

    PubMed

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

    2015-09-01

    The role of the US Food and Drug Administration (FDA) in medical device regulation is important to device-driven specialties such as interventional radiology. Whether it is through industry-sponsored trials during the approval process for new devices or investigator-initiated research prospectively evaluating the role of existing devices for new or established procedures, interaction with the FDA is an integral part of performing significant research in interventional radiology. This article reviews the potential areas of interface between the FDA and interventional radiology, as understanding these areas is necessary to continue the innovation that is the hallmark of this specialty. PMID:26189046

  9. Medical devices; refurbishers, rebuilders, reconditioners, servicers, and "as is" remarketers of medical devices; review and revision of compliance policy guides and regulatory requirements; request for comments and information--FDA. Advance notice of proposed rulemaking.

    PubMed

    1997-12-23

    The Food and Drug Administration (FDA) is announcing its intention to review and, as necessary, to revise or to amend its compliance policy guides and regulatory requirements relating to the remarketing of used medical devices and the persons who refurbish, recondition, rebuild, service, or remarket such devices. The agency is considering these actions because it believes evolving industry practices warrant reevaluation of current policy and the application of certain regulatory requirements in order to ensure that particular remarketed devices meet suitable performance requirements for their intended uses, and are as safe as the originally marketed finished device. FDA is soliciting comments, proposals for alternative regulatory approaches, and information on these issues. In a future issue of the Federal Register, FDA will announce an open meeting of the Good Manufacturing Practices (GMP) Advisory Committee concerning these matters. PMID:10179309

  10. Consumers' Understanding of FDA Approval Requirements and Composite Scores in Direct-to-Consumer Prescription Drug Print Ads.

    PubMed

    O'Donoghue, Amie C; Sullivan, Helen W; Williams, Pamela A; Squire, Claudia; Betts, Kevin R; Fitts Willoughby, Jessica; Parvanta, Sarah

    2016-08-01

    In 2 studies, we investigated how laypersons perceive the Food and Drug Administration (FDA) approval process, FDA authority, and the presentation of composite scores in direct-to-consumer (DTC) prescription drug print ads. The 1st study consisted of 4 focus groups (N = 38) in 2 cities. Using a semi-structured guide, a moderator led participants through the viewing of 3 existing DTC print ads that differed in the presence or absence of composite score information, and participants discussed their views of the ads and their understanding of composite scores. The 2nd study surveyed a nationally representative sample of 1,629 individuals from the general population who saw a fictitious DTC print ad and answered closed-ended questions about the same topics. Results showed that knowledge of FDA approval and authority was mixed, with several misconceptions apparent. Many consumers were not familiar with the use of composite scores in a medical context or in advertising and, in the 1st study, expressed distrust of the product and the ad after learning about how composite scores are used. In the 2nd study, receiving composite score information changed the perceived clarity of the ad but not the perceived risk or benefits. Implications for the presentation of complex medical information are discussed. PMID:27414000

  11. Drugs@FDA: FDA Approved Drug Products

    MedlinePlus

    ... Cosmetics Tobacco Products Drugs@FDA: FDA Approved Drug Products FDA Home Drug Databases Drugs@FDA - FAQ | Instructions | ... 6332) Contact FDA For Government For Press Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency ...

  12. BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements.

    PubMed

    Davit, Barbara M; Kanfer, Isadore; Tsang, Yu Chung; Cardot, Jean-Michel

    2016-05-01

    The Biopharmaceutics Classification System (BCS), based on aqueous solubility and intestinal permeability, has enjoyed wide use since 1995 as a mechanism for waiving in vivo bioavailability and bioequivalence studies. In 2000, the US-FDA was the first regulatory agency to publish guidance for industry describing how to meet criteria for requesting a waiver of in vivo bioavailability and bioequivalence studies for highly soluble, highly permeable (BCS Class I) drugs. Subsequently, the World Health Organization (WHO) and European Medicines Agency (EMA) published guidelines recommending how to obtain BCS biowaivers for BCS Class III drugs (high solubility, low permeability), in addition to Class I drugs. In 2015, the US-FDA became better harmonized with the EMA and WHO following publication of two guidances for industry outlining criteria for obtaining BCS biowaivers for both Class I and Class III drugs. A detailed review and comparison of the BCS Class I and Class III criteria currently recommended by the US-FDA, EMA, and WHO revealed good convergence of the three agencies with respect to BCS biowaiver criteria. The comparison also suggested that, by applying the most conservative of the three jurisdictional approaches, it should be possible for a sponsor to design the same set of BCS biowaiver studies in preparing a submission for worldwide filing to satisfy US, European, and emerging market regulators. It is hoped that the availability of BCS Class I and Class III biowaivers in multiple jurisdictions will encourage more sponsors to request waivers of in vivo bioavailability/bioequivalence testing using the BCS approach. PMID:26943914

  13. 76 FR 38184 - Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Recall...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-29

    ... Collection; Comment Request; FDA Recall Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice... reporting requirements on FDA recalls. DATES: Submit either electronic or written comments on the collection... techniques, when appropriate, and other forms of information technology. FDA Recall Regulations--21 CFR...

  14. Implementation of the mutual recognition agreement between the United States and the European Community; pharmaceutical GMP's and medical devices; establishment of a public docket and FDA contact points. Food and Drug Administration, HHS. Establishment of a public docket and FDA contact points.

    PubMed

    1999-03-01

    The Food and Drug Administration (FDA) is announcing the establishment of a public docket for the submission and public availability of information concerning the implementation of the Mutual Recognition Agreement (MRA) between the United States and the European Community (EC) in the areas of pharmaceutical good manufacturing practices (GMP's) and medical devices. FDA is also establishing contact points for information covering particular subjects under the MRA implementation, and the agency is making appropriate information available on the FDA web site. PMID:10557625

  15. FDA 101: Dietary Supplements

    MedlinePlus

    ... professionals. As its resources permit, FDA also reviews product labels and other product information, such as package inserts, ... the address or phone number listed on the product's label. Dietary supplement firms are required to forward reports ...

  16. FDA Approval for Imiquimod

    Cancer.gov

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

  17. A Guide to the FDA.

    ERIC Educational Resources Information Center

    Miller, Annetta K.

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

  18. Administratively required dental radiographs: radiation recommendation series. Final report

    SciTech Connect

    Not Available

    1981-09-01

    This publication is part of the continuing Radiation Recommendation Series published by the Bureau of Radiological Health. This Series was established to provide physicians, medical physicists, technologists, and others involved in the radiological process with guidance on appropriate radiological health principles in the medical radiation area. Administrative requirements for radiographs are found in many segments of the United States health care system. Such requirements are not intrinsically bad. If the resulting x-ray examinations provide a net public health benefit, they are certainly justified. However, where such examinations do not benefit the care and management of the patient, the requirements should be reviewed to determine whether they can be eliminated. This document presents an FDA radiation recommendation on administratively required dental x-ray examinations. In general such examinations are not requested to further the patient's dental health, but rather as a means of monitoring claims. However, the administrative use of radiographs that have been taken in the normal course of patient care is usually appropriate, as long as the patient's right to privacy is respected.

  19. 50 CFR 253.54 - Administrative requirements.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 50 Wildlife and Fisheries 11 2013-10-01 2013-10-01 false Administrative requirements. 253.54 Section 253.54 Wildlife and Fisheries NATIONAL MARINE FISHERIES SERVICE, NATIONAL OCEANIC AND ATMOSPHERIC... Fisheries § 253.54 Administrative requirements. Federal assistance awards made as a result of this Act...

  20. 50 CFR 253.24 - Administrative requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 50 Wildlife and Fisheries 7 2010-10-01 2010-10-01 false Administrative requirements. 253.24 Section 253.24 Wildlife and Fisheries NATIONAL MARINE FISHERIES SERVICE, NATIONAL OCEANIC AND ATMOSPHERIC... Fisheries § 253.24 Administrative requirements. Federal assistance awards made as a result of this Act...

  1. 50 CFR 253.54 - Administrative requirements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 50 Wildlife and Fisheries 9 2011-10-01 2011-10-01 false Administrative requirements. 253.54 Section 253.54 Wildlife and Fisheries NATIONAL MARINE FISHERIES SERVICE, NATIONAL OCEANIC AND ATMOSPHERIC... Fisheries § 253.54 Administrative requirements. Federal assistance awards made as a result of this Act...

  2. 43 CFR 32.5 - Administrative requirements.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 43 Public Lands: Interior 1 2012-10-01 2011-10-01 true Administrative requirements. 32.5 Section 32.5 Public Lands: Interior Office of the Secretary of the Interior GRANTS TO STATES FOR ESTABLISHING YOUNG ADULT CONSERVATION CORPS (YACC) PROGRAM § 32.5 Administrative requirements. (a) The Governor...

  3. 43 CFR 32.5 - Administrative requirements.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 43 Public Lands: Interior 1 2013-10-01 2013-10-01 false Administrative requirements. 32.5 Section 32.5 Public Lands: Interior Office of the Secretary of the Interior GRANTS TO STATES FOR ESTABLISHING YOUNG ADULT CONSERVATION CORPS (YACC) PROGRAM § 32.5 Administrative requirements. (a) The Governor...

  4. 43 CFR 32.5 - Administrative requirements.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 43 Public Lands: Interior 1 2014-10-01 2014-10-01 false Administrative requirements. 32.5 Section 32.5 Public Lands: Interior Office of the Secretary of the Interior GRANTS TO STATES FOR ESTABLISHING YOUNG ADULT CONSERVATION CORPS (YACC) PROGRAM § 32.5 Administrative requirements. (a) The Governor...

  5. 43 CFR 32.5 - Administrative requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Administrative requirements. 32.5 Section 32.5 Public Lands: Interior Office of the Secretary of the Interior GRANTS TO STATES FOR ESTABLISHING YOUNG ADULT CONSERVATION CORPS (YACC) PROGRAM § 32.5 Administrative requirements. (a) The Governor...

  6. 43 CFR 32.5 - Administrative requirements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 1 2011-10-01 2011-10-01 false Administrative requirements. 32.5 Section 32.5 Public Lands: Interior Office of the Secretary of the Interior GRANTS TO STATES FOR ESTABLISHING YOUNG ADULT CONSERVATION CORPS (YACC) PROGRAM § 32.5 Administrative requirements. (a) The Governor...

  7. 78 FR 20664 - Society of Clinical Research Associates-Food and Drug Administration: Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-05

    ... Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good... Society of Clinical Research Associates (SOCRA). The conference on FDA's clinical trial requirements is... relationships among FDA and clinical trial staff, investigators, and institutional review boards...

  8. Internet Database Review: The FDA BBS.

    ERIC Educational Resources Information Center

    Tomaiuolo, Nicholas G.

    1993-01-01

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

  9. 43 CFR 26.5 - Administrative requirements.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... YOUTH CONSERVATION CORPS PROGRAMS § 26.5 Administrative requirements. The following administrative... designed to assure: (1) An equal opportunity for both sexes, for all urban and rural youth regardless of..., disadvantaged, non-public school youth, and youth having left school before graduation; (2) That selections...

  10. 43 CFR 26.5 - Administrative requirements.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... YOUTH CONSERVATION CORPS PROGRAMS § 26.5 Administrative requirements. The following administrative... designed to assure: (1) An equal opportunity for both sexes, for all urban and rural youth regardless of..., disadvantaged, non-public school youth, and youth having left school before graduation; (2) That selections...

  11. 40 CFR 35.6815 - Administrative requirements.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Administrative requirements. 35.6815 Section 35.6815 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GRANTS AND OTHER FEDERAL ASSISTANCE STATE AND LOCAL ASSISTANCE Cooperative Agreements and Superfund State Contracts for Superfund Response Actions Requirements for...

  12. Gastroenterology-urology devices; effective date of requirement for premarket approval of the penile inflatable implant. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-04-12

    The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the penile inflatable implant, a generic type of medical device intended for the treatment of erectile dysfunction. This regulation reflects FDA's exercise of its discretion to require PMA's or PDP's for preamendments devices and is consistent with FDA's stated priorities and Congress' requirement that class III devices are to be regulated by FDA's premarket review. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. PMID:11010632

  13. Doctors, drugs, and the FDA.

    PubMed

    Shanklin, D R

    1972-11-01

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

  14. FDA's proposed rules on patent listing requirements for new drug and 30-month stays on ANDA approval (proposed Oct. 24, 2002).

    PubMed

    Hui, Yuk Fung

    2003-01-01

    In order to close the loophole in the generic drug approval process that allows a brand name drug patent holder to delay or defeat generic drug application merely by technicality, the FDA recently proposed to modify its regulations. Those proposals affect the patent listing requirements of a new drug application, and the duration of time that a generic drug application could be put on hold in the event of a patent infringement suit. With the modified rules, the FDA expects to see an increase in the availability of generic drugs, which eventually will lead to lower drug costs. Ms. Hui discusses the contents of the proposed regulations and provides an analysis of the proposed rule's legal authority, implications on patent rights, and impact on the pharmaceutical industry. PMID:12856462

  15. Administrative Actions for Noncompliance; Lesser Administrative Actions. Direct final rule.

    PubMed

    2016-04-01

    The Food and Drug Administration (FDA) is amending the regulation describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with FDA's IRB regulations. We are clarifying that FDA may require the IRB to withhold approval of new FDA-regulated studies, stop the enrollment of new subjects in ongoing studies, and terminate ongoing studies, or any combination of these actions until the noncompliance with FDA's IRB regulations is corrected. We are taking this action to ensure clarity and improve the accuracy of the regulations. PMID:27044118

  16. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to records. Each device manufacturer or importer required under this part to maintain records and...

  17. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to records. Each device manufacturer or importer required under this part to maintain records and...

  18. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to records. Each device manufacturer or importer required under this part to maintain records and...

  19. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to records. Each device manufacturer or importer required under this part to maintain records and...

  20. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to records. Each device manufacturer or importer required under this part to maintain records and...

  1. 78 FR 55728 - Society of Clinical Research Associates-Food and Drug Administration: Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-11

    ... Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good... workshop regarding FDA's clinical trial requirements is designed to aid the clinical research professional... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  2. 27 CFR 17.136 - Compliance with Food and Drug Administration requirements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... violate a ban or restriction of the U.S. Food and Drug Administration (FDA) pertaining to such products. If FDA bans or restricts the use of any ingredient in such a way that further manufacture of a product in accordance with its formula would violate the ban or restriction, then the manufacturer...

  3. [Discussion about traditional Chinese medicine pharmacokinetics study based on first botanical drug approved by FDA].

    PubMed

    Huang, Fanghua

    2010-04-01

    Pharmacokinetics study is one of main components of pharmaceuticals development. Food and Drug Administration (FDA) approved Veregen as the first botanical drug in 2006. This article introduced FDA's requirement on pharmacokinetics study of botanical drug and pharmacokinetics studies of Veregen, summarized current requirement and status quo of pharmacokinetics study on traditional Chinese medicine (TCM) and natural medicine in China, and discussed about pharmacokinetics study strategy for TCM and natural medicine. PMID:20575403

  4. Access to F.D.A. Information.

    ERIC Educational Resources Information Center

    Sinovic, Dianna

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

  5. FDA Modernizes Nutrition Facts Label for Packaged Foods

    MedlinePlus

    ... Department of Health and Human Services FDA U.S. Food and Drug Administration Protecting and Promoting Your Health ... Release FDA modernizes Nutrition Facts label for packaged foods Refreshed design and relevant information will help consumers ...

  6. 76 FR 6477 - Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-04

    ..., Food and Drug Administration, 4040 North Central Expressway, suite 900, Dallas, Texas 75204, 214-253-4952, FAX: 214-253-4970, e-mail: David.Arvelo@fda.hhs.gov . Registration: You are encouraged...

  7. 47 CFR 64.623 - Administrator requirements.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... section, the term “Administrator” shall refer to each of the TRS Numbering administrator, the administrator of the TRS User Registration Database, the administrator of the VRS Access Technology Reference... entity that is impartial and not an affiliate of any Internet-based TRS provider. (2) Neither...

  8. 47 CFR 64.623 - Administrator requirements.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... section, the term “Administrator” shall refer to each of the TRS Numbering administrator, the administrator of the TRS User Registration Database, the administrator of the VRS Access Technology Reference... entity that is impartial and not an affiliate of any Internet-based TRS provider. (2) Neither...

  9. FDA Approves Implant to Battle Opioid Addiction

    MedlinePlus

    ... 159050.html FDA Approves Implant to Battle Opioid Addiction Experts say steady dosing eliminates need to take ... U.S. Food and Drug Administration. "Opioid abuse and addiction have taken a devastating toll on American families. ...

  10. 48 CFR 1516.303-77 - Administrative requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Administrative requirements... Administrative requirements. (a) The initial Procurement Request shall reflect the total estimated cost of the... records may be subject to an Agency audit....

  11. 76 FR 13643 - FDA Food Safety Modernization Act: Title III-A New Paradigm for Importers; Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-14

    ... accountability for domestic and foreign food and animal feed firms in the supply chain from farm to U.S. table... HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2011-N-0134, FDA-2011-N-0143, FDA-2011-N-0144, FDA- 2011-N-0145, and FDA-2011-N-0146] FDA Food Safety Modernization Act: Title III--A...

  12. 45 CFR 84.9 - Administrative requirements for small recipients.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 1 2010-10-01 2010-10-01 false Administrative requirements for small recipients. 84.9 Section 84.9 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION... Provisions § 84.9 Administrative requirements for small recipients. The Director may require any...

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

    PubMed

    Ferrer, Elisa

    2010-06-01

    Creation and clearance of pharmaceutical trademarks continues to be one of the most difficult and challenging areas of trademark law. The Food and Drug Administration (FDA) recently initiated a 2-year Pilot Program under Prescription Drug User Fee Act (PDUFA) IV. The intent of the program is to enable participating pharmaceutical firms to evaluate proposed pharmaceutical marks and submit the data generated from those evaluations to the FDA for review. Submitting a trademark to the FDA warrants questions: What supporting data is needed and accepted when proposing a mark? What issues might arise, and how can they be averted? In a recent Thomson Reuters on-demand webinar (http://science.thomsonreuters.com/news/2010-02/8580404/), a group of renowned experts in the field of trademark development review the FDA pilot program, outline the requirements for submission and discuss what the changes will mean in clearing new pharmaceutical marks. They also present various approaches to trademark development and evaluation in light of the FDA's views. PMID:20603657

  14. 21 CFR 60.34 - FDA action on petitions.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false FDA action on petitions. 60.34 Section 60.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT TERM RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives...

  15. 14 CFR 1251.108 - Administrative requirements for small recipients.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true Administrative requirements for small recipients. 1251.108 Section 1251.108 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION NONDISCRIMINATION ON BASIS OF HANDICAP General Provisions § 1251.108 Administrative requirements for...

  16. FDA Certified Mammography Facilities

    MedlinePlus

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

  17. 43 CFR 17.208 - Administrative requirements for small recipients.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 1 2011-10-01 2011-10-01 false Administrative requirements for small recipients. 17.208 Section 17.208 Public Lands: Interior Office of the Secretary of the Interior... Handicap § 17.208 Administrative requirements for small recipients. The Director may require any...

  18. 42 CFR 51.4 - Grants administration requirements.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 1 2014-10-01 2014-10-01 false Grants administration requirements. 51.4 Section 51.4 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS REQUIREMENTS APPLICABLE TO THE PROTECTION AND ADVOCACY FOR INDIVIDUALS WITH MENTAL ILLNESS PROGRAM Basic Requirements § 51.4 Grants administration...

  19. 7 CFR 272.4 - Program administration and personnel requirements.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 4 2013-01-01 2013-01-01 false Program administration and personnel requirements. 272... NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE FOOD STAMP AND FOOD DISTRIBUTION PROGRAM REQUIREMENTS FOR PARTICIPATING STATE AGENCIES § 272.4 Program administration and personnel requirements. (a) Merit personnel....

  20. 45 CFR 164.530 - Administrative requirements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... as required by § 164.520(b)(3) to state the changed practice and make the revised notice available as... workforce whose functions are affected by a material change in the policies or procedures required by this subpart or subpart D of this part, within a reasonable period of time after the material change...

  1. 45 CFR 164.530 - Administrative requirements.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... as required by § 164.520(b)(3) to state the changed practice and make the revised notice available as... workforce whose functions are affected by a material change in the policies or procedures required by this subpart or subpart D of this part, within a reasonable period of time after the material change...

  2. 45 CFR 164.530 - Administrative requirements.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... as required by § 164.520(b)(3) to state the changed practice and make the revised notice available as... workforce whose functions are affected by a material change in the policies or procedures required by this subpart or subpart D of this part, within a reasonable period of time after the material change...

  3. 45 CFR 164.530 - Administrative requirements.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... as required by § 164.520(b)(3) to state the changed practice and make the revised notice available as... workforce whose functions are affected by a material change in the policies or procedures required by this subpart or subpart D of this part, within a reasonable period of time after the material change...

  4. 40 CFR 35.6815 - Administrative requirements.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... must comply with the requirements described in 40 CFR 31.52(a) regarding collection of amounts due. (3... water distribution system, once EPA certifies that the remedy is operational and functional. (c)...

  5. The food and drug administration is now preparing to establish tighter performance requirements for blood glucose monitors.

    PubMed

    Klonoff, David C

    2010-05-01

    On March 16 and 17, 2010, the Food and Drug Administration (FDA) presented a public meeting about blood glucose monitoring at the Gaithersberg Hilton Hotel. The meeting was intended to present expert opinions and solicit input from the public about whether to develop new regulatory policies for blood glucose monitors. The meeting was divided into three sections: (1) Clinical Accuracy Requirements for Blood Glucose Monitors, (2) Interferences and Limitations of Blood Glucose Monitors, and (3) Tight Glycemic Control. Many officials from the Center for Devices and Radiologic Health and the Office of In Vitro Diagnostic Devices, which are the parts of FDA that regulate approval of blood glucose monitors, either spoke on the agenda or attended in the audience. Approximately 300 people attended; they were mostly clinicians (such as adult endocrinologists, pediatric endocrinologists, internists, clinical chemists, intensivists, surgeons, nurses, and diabetes educators) or industry officials from companies involved in glucose monitoring, pharmaceutical products, data analysis, or regulatory consulting. PMID:20513313

  6. 24 CFR 1006.370 - Federal administrative requirements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... State, Local and Indian Tribal Governments,” and with 24 CFR part 85 “Uniform Administrative... Non-profit Organizations,” and the requirements of 24 CFR part 84, “Uniform Administrative... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false Federal administrative...

  7. 24 CFR 1006.370 - Federal administrative requirements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... State, Local and Indian Tribal Governments,” and with 24 CFR part 85 “Uniform Administrative... Non-profit Organizations,” and the requirements of 24 CFR part 84, “Uniform Administrative... 24 Housing and Urban Development 4 2011-04-01 2011-04-01 false Federal administrative...

  8. 20 CFR 404.1620 - General administrative requirements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false General administrative requirements. 404.1620 Section 404.1620 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ) Determinations of Disability Administrative Responsibilities and...

  9. 20 CFR 404.1620 - General administrative requirements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false General administrative requirements. 404.1620 Section 404.1620 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ) Determinations of Disability Administrative Responsibilities and...

  10. 20 CFR 404.1620 - General administrative requirements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false General administrative requirements. 404.1620 Section 404.1620 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ) Determinations of Disability Administrative Responsibilities and...

  11. 20 CFR 404.1620 - General administrative requirements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 20 Employees' Benefits 2 2013-04-01 2013-04-01 false General administrative requirements. 404.1620 Section 404.1620 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ) Determinations of Disability Administrative Responsibilities and...

  12. 20 CFR 404.1620 - General administrative requirements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 20 Employees' Benefits 2 2014-04-01 2014-04-01 false General administrative requirements. 404.1620 Section 404.1620 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ) Determinations of Disability Administrative Responsibilities and...

  13. 43 CFR 26.5 - Administrative requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... project should be assigned as near as possible an equal number of slots for males and females; (3) That... home to a residential YCC project. (c) Capital outlays for facilities should be kept at a minimum. No... custodial requirements for records are prescribed by attachment C to OMB circular A-102. (n) A...

  14. 45 CFR 304.10 - General administrative requirements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... of 45 CFR 74.23, Cost Sharing or Matching and 45 CFR 74.52, Financial Reporting) establishing uniform... 45 Public Welfare 2 2011-10-01 2011-10-01 false General administrative requirements. 304.10... HUMAN SERVICES FEDERAL FINANCIAL PARTICIPATION § 304.10 General administrative requirements. As...

  15. 24 CFR 570.502 - Applicability of uniform administrative requirements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Governments”; OMB Circular A-128, “Audits of State and Local Governments” (implemented at 24 CFR part 44); and with the following sections of 24 CFR part 85 “Uniform Administrative Requirements for Grants and... Uniform Administrative requirements of OMB Circular A-110 (implemented at 24 CFR part 84,...

  16. 45 CFR 304.10 - General administrative requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... of 45 CFR 74.23, Cost Sharing or Matching and 45 CFR 74.52, Financial Reporting) establishing uniform... 45 Public Welfare 2 2010-10-01 2010-10-01 false General administrative requirements. 304.10... HUMAN SERVICES FEDERAL FINANCIAL PARTICIPATION § 304.10 General administrative requirements. As...

  17. 24 CFR 570.502 - Applicability of uniform administrative requirements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Governments”; OMB Circular A-128, “Audits of State and Local Governments” (implemented at 24 CFR part 44); and with the following sections of 24 CFR part 85 “Uniform Administrative Requirements for Grants and... Uniform Administrative requirements of OMB Circular A-110 (implemented at 24 CFR part 84,...

  18. 24 CFR 964.230 - Audit and administrative requirements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false Audit and administrative... Program § 964.230 Audit and administrative requirements. (a) TOP grant recipients. The HUD Inspector... purpose of audit or other examinations. (1) Grant recipients must comply with the requirements of...

  19. 44 CFR 208.64 - Administrative and audit requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Reimbursement Claims and Appeals § 208.64 Administrative and audit requirements. (a) Non-Federal audit. For Sponsoring Agencies and States, requirements for non-Federal audit are contained in 44 CFR 13.26, in... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Administrative and...

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

    PubMed

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

    2015-03-01

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

  1. 76 FR 61709 - Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Form 3728...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-05

    ...The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of......

  2. 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. PMID:27068243

  3. OpenVigil FDA – Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications

    PubMed Central

    Böhm, Ruwen; von Hehn, Leocadie; Herdegen, Thomas; Klein, Hans-Joachim; Bruhn, Oliver; Petri, Holger; Höcker, Jan

    2016-01-01

    Pharmacovigilance contributes to health care. However, direct access to the underlying data for academic institutions and individual physicians or pharmacists is intricate, and easily employable analysis modes for everyday clinical situations are missing. This underlines the need for a tool to bring pharmacovigilance to the clinics. To address these issues, we have developed OpenVigil FDA, a novel web-based pharmacovigilance analysis tool which uses the openFDA online interface of the Food and Drug Administration (FDA) to access U.S. American and international pharmacovigilance data from the Adverse Event Reporting System (AERS). OpenVigil FDA provides disproportionality analyses to (i) identify the drug most likely evoking a new adverse event, (ii) compare two drugs concerning their safety profile, (iii) check arbitrary combinations of two drugs for unknown drug-drug interactions and (iv) enhance the relevance of results by identifying confounding factors and eliminating them using background correction. We present examples for these applications and discuss the promises and limits of pharmacovigilance, openFDA and OpenVigil FDA. OpenVigil FDA is the first public available tool to apply pharmacovigilance findings directly to real-life clinical problems. OpenVigil FDA does not require special licenses or statistical programs. PMID:27326858

  4. OpenVigil FDA - Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications.

    PubMed

    Böhm, Ruwen; von Hehn, Leocadie; Herdegen, Thomas; Klein, Hans-Joachim; Bruhn, Oliver; Petri, Holger; Höcker, Jan

    2016-01-01

    Pharmacovigilance contributes to health care. However, direct access to the underlying data for academic institutions and individual physicians or pharmacists is intricate, and easily employable analysis modes for everyday clinical situations are missing. This underlines the need for a tool to bring pharmacovigilance to the clinics. To address these issues, we have developed OpenVigil FDA, a novel web-based pharmacovigilance analysis tool which uses the openFDA online interface of the Food and Drug Administration (FDA) to access U.S. American and international pharmacovigilance data from the Adverse Event Reporting System (AERS). OpenVigil FDA provides disproportionality analyses to (i) identify the drug most likely evoking a new adverse event, (ii) compare two drugs concerning their safety profile, (iii) check arbitrary combinations of two drugs for unknown drug-drug interactions and (iv) enhance the relevance of results by identifying confounding factors and eliminating them using background correction. We present examples for these applications and discuss the promises and limits of pharmacovigilance, openFDA and OpenVigil FDA. OpenVigil FDA is the first public available tool to apply pharmacovigilance findings directly to real-life clinical problems. OpenVigil FDA does not require special licenses or statistical programs. PMID:27326858

  5. 24 CFR 570.489 - Program administrative requirements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... and undertaken in accordance with the requirements of this part and 24 CFR part 58. A state may incur... payments upon such requests, must comply with 31 CFR part 205. The state must use procedures to minimize... requirements; or (iii) Applying the provisions in 24 CFR part 85 “Uniform Administrative Requirements...

  6. 24 CFR 570.489 - Program administrative requirements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... and undertaken in accordance with the requirements of this part and 24 CFR part 58. A state may incur... payments upon such requests, must comply with 31 CFR part 205. The state must use procedures to minimize... requirements; or (iii) Applying the provisions in 24 CFR part 85 “Uniform Administrative Requirements...

  7. 24 CFR 1006.370 - Federal administrative requirements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... State, Local and Indian Tribal Governments,” and with 24 CFR part 85 “Uniform Administrative... Non-profit Organizations,” and the requirements of 24 CFR part 84, “Uniform Administrative... referenced in this part may be obtained from www.whitehouse.gov/omb/circulars/index.html; telephone;...

  8. 20 CFR 416.1020 - General administrative requirements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false General administrative requirements. 416.1020 Section 416.1020 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE... substantially failing to follow our regulations or other written guidelines. (b) The State is responsible...

  9. 45 CFR 1385.9 - Grants administration requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Grants administration requirements. (a) The following parts of title 45 CFR apply to grants funded under... 162 of the Act (42 U.S.C. 6082). 45 CFR Part 16—Procedures of the Departmental Grant Appeals Board. 45 CFR Part 46—Protection of Human Subjects. 45 CFR Part 74—Administration of Grants. 45 CFR Part...

  10. 47 CFR 400.9 - Financial and administrative requirements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ..., DEPARTMENT OF COMMERCE, AND NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION E... 49 CFR part 18, the Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments, including applicable cost principles referenced at 49 CFR 18.22, govern...

  11. 47 CFR 400.9 - Financial and administrative requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ..., DEPARTMENT OF COMMERCE, AND NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION E... 49 CFR part 18, the Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments, including applicable cost principles referenced at 49 CFR 18.22, govern...

  12. 47 CFR 400.9 - Financial and administrative requirements.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ..., DEPARTMENT OF COMMERCE, AND NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION E... 49 CFR part 18, the Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments, including applicable cost principles referenced at 49 CFR 18.22, govern...

  13. 47 CFR 400.9 - Financial and administrative requirements.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ..., DEPARTMENT OF COMMERCE, AND NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION E... 49 CFR part 18, the Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments, including applicable cost principles referenced at 49 CFR 18.22, govern...

  14. 47 CFR 400.9 - Financial and administrative requirements.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ..., DEPARTMENT OF COMMERCE, AND NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION E... 49 CFR part 18, the Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments, including applicable cost principles referenced at 49 CFR 18.22, govern...

  15. 45 CFR 1385.9 - Grants administration requirements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Grants administration requirements. (a) The following parts of title 45 CFR apply to grants funded under... 162 of the Act (42 U.S.C. 6082). 45 CFR Part 16—Procedures of the Departmental Grant Appeals Board. 45 CFR Part 46—Protection of Human Subjects. 45 CFR Part 74—Administration of Grants. 45 CFR Part...

  16. 45 CFR 1336.50 - Financial and administrative requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 4 2010-10-01 2010-10-01 false Financial and administrative requirements. 1336.50 Section 1336.50 Public Welfare Regulations Relating to Public Welfare (Continued) OFFICE OF HUMAN DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION FOR NATIVE AMERICANS, NATIVE AMERICAN PROGRAMS NATIVE...

  17. 77 FR 31026 - Requirements for Importing Food and Drug Administration Regulated Products Into the United States

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-24

    ..., IL, 60016. Contact: Lisa Misevicz, Food and Drug Administration, 550 West Jackson Blvd., suite 1500, Chicago, IL 60661; 312-596-4217; email: lisa.misevicz@fda.hhs.gov . Registration: Send registration... July 2, 2012. If you need special accommodations due to a disability, please contact Lisa Misevicz...

  18. 7 CFR 272.4 - Program administration and personnel requirements.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 4 2012-01-01 2012-01-01 false Program administration and personnel requirements. 272.4 Section 272.4 Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE FOOD STAMP AND FOOD DISTRIBUTION PROGRAM REQUIREMENTS FOR PARTICIPATING STATE AGENCIES § 272.4...

  19. 44 CFR 206.207 - Administrative and audit requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... which are set forth in 44 CFR part 13 apply to all disaster assistance grants and subgrants. (b) State... administrative requirements of 44 CFR parts 13 and 206; (H) Compliance with the audit requirements of 44 CFR part... amount of pass-through funds for management costs provided under 44 CFR part 207 that the grantee...

  20. 45 CFR 96.30 - Fiscal and administrative requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Financial Management § 96.30 Fiscal and administrative requirements. (a) Fiscal control and accounting... the restrictions and prohibitions of the statute authorizing the block grant. (b) Financial summary of... required by paragraph (b)(1), (2), and (3) of this section on OMB Standard Form 269A, Financial...

  1. 45 CFR 96.30 - Fiscal and administrative requirements.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Financial Management § 96.30 Fiscal and administrative requirements. (a) Fiscal control and accounting... the restrictions and prohibitions of the statute authorizing the block grant. (b) Financial summary of... required by paragraph (b)(1), (2), and (3) of this section on OMB Standard Form 269A, Financial...

  2. 45 CFR 96.30 - Fiscal and administrative requirements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Financial Management § 96.30 Fiscal and administrative requirements. (a) Fiscal control and accounting... the restrictions and prohibitions of the statute authorizing the block grant. (b) Financial summary of... required by paragraph (b)(1), (2), and (3) of this section on OMB Standard Form 269A, Financial...

  3. 42 CFR 51.4 - Grants administration requirements.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Requirements for Drug-Free Workplace. 45 CFR Part 80—Nondiscrimination under Programs Receiving Federal... from Federal Financial Assistance. 45 CFR Part 86—Nondiscrimination on the Basis of Sex in Education....4 Grants administration requirements. The following parts of titles 42 and 45 CFR apply to...

  4. 42 CFR 51.4 - Grants administration requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Requirements for Drug-Free Workplace. 45 CFR Part 80—Nondiscrimination under Programs Receiving Federal... from Federal Financial Assistance. 45 CFR Part 86—Nondiscrimination on the Basis of Sex in Education....4 Grants administration requirements. The following parts of titles 42 and 45 CFR apply to...

  5. 42 CFR 51.4 - Grants administration requirements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Requirements for Drug-Free Workplace. 45 CFR Part 80—Nondiscrimination under Programs Receiving Federal... from Federal Financial Assistance. 45 CFR Part 86—Nondiscrimination on the Basis of Sex in Education....4 Grants administration requirements. The following parts of titles 42 and 45 CFR apply to...

  6. 42 CFR 51.4 - Grants administration requirements.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Requirements for Drug-Free Workplace. 45 CFR Part 80—Nondiscrimination under Programs Receiving Federal... from Federal Financial Assistance. 45 CFR Part 86—Nondiscrimination on the Basis of Sex in Education....4 Grants administration requirements. The following parts of titles 42 and 45 CFR apply to...

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

    PubMed Central

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

    2015-01-01

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

  8. Analytical Performance Requirements for Systems for Self-Monitoring of Blood Glucose With Focus on System Accuracy: Relevant Differences Among ISO 15197:2003, ISO 15197:2013, and Current FDA Recommendations.

    PubMed

    Freckmann, Guido; Schmid, Christina; Baumstark, Annette; Rutschmann, Malte; Haug, Cornelia; Heinemann, Lutz

    2015-07-01

    In the European Union (EU), the ISO (International Organization for Standardization) 15197 standard is applicable for the evaluation of systems for self-monitoring of blood glucose (SMBG) before the market approval. In 2013, a revised version of this standard was published. Relevant revisions in the analytical performance requirements are the inclusion of the evaluation of influence quantities, for example, hematocrit, and some changes in the testing procedures for measurement precision and system accuracy evaluation, for example, number of test strip lots. Regarding system accuracy evaluation, the most important change is the inclusion of more stringent accuracy criteria. In 2014, the Food and Drug Administration (FDA) in the United States published their own guidance document for the premarket evaluation of SMBG systems with even more stringent system accuracy criteria than stipulated by ISO 15197:2013. The establishment of strict accuracy criteria applicable for the premarket evaluation is a possible approach to further improve the measurement quality of SMBG systems. However, the system accuracy testing procedure is quite complex, and some critical aspects, for example, systematic measurement difference between the reference measurement procedure and a higher-order procedure, may potentially limit the apparent accuracy of a given system. Therefore, the implementation of a harmonized reference measurement procedure for which traceability to standards of higher order is verified through an unbroken, documented chain of calibrations is desirable. In addition, the establishment of regular and standardized post-marketing evaluations of distributed test strip lots should be considered as an approach toward an improved measurement quality of available SMBG systems. PMID:25872965

  9. 21 CFR 314.102 - Communications between FDA and applicants.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Section 314.102 Food 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 FDA Action on Applications... application needed to facilitate the agency's review. This early communication is intended to...

  10. 21 CFR 314.102 - Communications between FDA and applicants.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Section 314.102 Food 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 FDA Action on Applications... process. Such communication may take the form of telephone conversations, letters, or meetings,...

  11. 21 CFR 1.393 - What information must FDA include in the detention order?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention...

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

    PubMed Central

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

    2015-01-01

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

  13. 32 CFR 700.106 - Control of administrative requirements.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 32 National Defense 5 2011-07-01 2011-07-01 false Control of administrative requirements. 700.106 Section 700.106 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY UNITED STATES NAVY REGULATIONS AND OFFICIAL RECORDS UNITED STATES NAVY REGULATIONS AND OFFICIAL RECORDS...

  14. 32 CFR 700.106 - Control of administrative requirements.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 32 National Defense 5 2012-07-01 2012-07-01 false Control of administrative requirements. 700.106 Section 700.106 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY UNITED STATES NAVY REGULATIONS AND OFFICIAL RECORDS UNITED STATES NAVY REGULATIONS AND OFFICIAL RECORDS...

  15. 32 CFR 700.106 - Control of administrative requirements.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 5 2010-07-01 2010-07-01 false Control of administrative requirements. 700.106 Section 700.106 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY UNITED STATES NAVY REGULATIONS AND OFFICIAL RECORDS UNITED STATES NAVY REGULATIONS AND OFFICIAL RECORDS...

  16. 32 CFR 700.106 - Control of administrative requirements.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 5 2014-07-01 2014-07-01 false Control of administrative requirements. 700.106 Section 700.106 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY UNITED STATES NAVY REGULATIONS AND OFFICIAL RECORDS UNITED STATES NAVY REGULATIONS AND OFFICIAL RECORDS...

  17. 32 CFR 700.106 - Control of administrative requirements.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 32 National Defense 5 2013-07-01 2013-07-01 false Control of administrative requirements. 700.106 Section 700.106 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY UNITED STATES NAVY REGULATIONS AND OFFICIAL RECORDS UNITED STATES NAVY REGULATIONS AND OFFICIAL RECORDS...

  18. 24 CFR 570.489 - Program administrative requirements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... this subpart and 24 CFR part 58. (c) Federal grant payments—(1) Payments. The state shall be paid in advance in accordance with Treasury Circular 1075 (31 CFR part 205). The State shall use procedures to...) Applying the provisions in 24 CFR part 85 “Uniform Administrative Requirements for Grants and...

  19. 42 CFR 441.615 - Administration fee requirements.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... SERVICES Vaccines for Children Program § 441.615 Administration fee requirements. (a) Under the VFC Program, a provider who administers a qualified pediatric vaccine to a federally vaccine-eligible child, may not impose a charge for the cost of the vaccine. (1) A provider can impose a fee for...

  20. 24 CFR 570.489 - Program administrative requirements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... this subpart and 24 CFR part 58. (c) Federal grant payments—(1) Payments. The state shall be paid in advance in accordance with Treasury Circular 1075 (31 CFR part 205). The State shall use procedures to...) Applying the provisions in 24 CFR part 85 “Uniform Administrative Requirements for Grants and...

  1. FDA pharmaceutical quality oversight.

    PubMed

    Yu, Lawrence X; Woodcock, Janet

    2015-08-01

    The launch of the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) is a milestone in FDA's efforts to assure that quality medicines are available to the American public. As a new super-office within CDER, OPQ is strategically organized to streamline regulatory processes, advance regulatory standards, align areas of expertise, and originate surveillance of drug quality. Supporting these objectives will be an innovative and systematic approach to product quality knowledge management and informatics. Concerted strategies will bring parity to the oversight of innovator and generic drugs as well as domestic and international facilities. OPQ will promote and encourage the adoption of emerging pharmaceutical technology to enhance pharmaceutical quality and potentially reinvigorate the pharmaceutical manufacturing sector in the United States. With a motto of "One Quality Voice," OPQ embodies the closer integration of review, inspection, surveillance, policy, and research for the purpose of strengthening pharmaceutical quality on a global scale. PMID:26027494

  2. NCI Director Also to Be Interim FDA Commissioner

    Cancer.gov

    Andrew von Eschenbach, M.D., director of the NCI, was asked by President Bush on Friday, September 23, 2005, to assume the additional role of interim Commissioner of the U.S. Food and Drug Administration (FDA).

  3. FDA OKs Non-Prescription Use of Acne Drug

    MedlinePlus

    ... 159779.html FDA OKs Non-Prescription Use of Acne Drug Differin Gel 0.1% is first retinoid ... July 8, 2016 (HealthDay News) -- Good news for acne sufferers: The U.S. Food and Drug Administration has ...

  4. FDA Calls for Less Salt in Processed Foods

    MedlinePlus

    ... html FDA Calls for Less Salt in Processed Foods Agency sets short- and long-term goals in ... WEDNESDAY, June 1, 2016 (HealthDay News) -- The U.S. Food and Drug Administration wants the food industry to ...

  5. Epidural steroid warning controversy still dogging FDA.

    PubMed

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

    2014-01-01

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

  6. The FDA's proposal for public disclosure of adverse events in gene therapy trials.

    PubMed

    Barnbaum, D R

    2000-09-01

    In January 2001, the Food and Drug Administration (FDA) proposed annual public disclosure of adverse events during gene therapy and xenotransplantation trials. The proposed policy raises the following questions: (1) Is the reformed policy in accord with the FDA's long-standing informed consent policies? (2) Why pair gene therapy trials and xenotransplantation trials in the revised guidelines? (3) Why single out these trials for public disclosure of adverse events? Each question is examined, and three conclusions are drawn. First, the FDA's own policies on informed consent require prompter public disclosure of adverse events. Second, the coupling of gene therapy and xenotransplantation trials entails a conceptual mistake in the types of communities that are harmed by each therapy's related adverse events. Third, all clinical trials merit such public disclosure of adverse events, not only gene therapy and xenotransplantation trials. PMID:15468489

  7. Gastroenterology and urology devices; effective date of requirement for premarket approval of the implanted mechanical/hydraulic urinary continence device. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-09-26

    The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the implanted mechanical/hydraulic urinary continence device, a generic type of medical device intended for the treatment of urinary incontinence. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997. PMID:11503643

  8. 75 FR 69523 - Required Warnings for Cigarette Packages and Advertisements

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-12

    ...The Food and Drug Administration (FDA) is proposing to amend its regulations to add a new requirement for the display of health warnings on cigarette packages and in cigarette advertisements. The proposed rule would implement a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics depicting the......

  9. 21 CFR 807.87 - Information required in a premarket notification submission.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Information required in a premarket notification submission. 807.87 Section 807.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Food and Drug Administration (FDA) under section 519 of the act. FDA may require the submission of...

  10. The FDA's sentinel initiative--A comprehensive approach to medical product surveillance.

    PubMed

    Ball, R; Robb, M; Anderson, S A; Dal Pan, G

    2016-03-01

    In May 2008, the Department of Health and Human Services announced the launch of the Sentinel Initiative by the US Food and Drug Administration (FDA) to create the Sentinel System, a national electronic system for medical product safety surveillance. This system complements existing FDA surveillance capabilities that track adverse events reported after the use of FDA regulated products by allowing the FDA to proactively assess the safety of these products. PMID:26667601

  11. Will the Requirement by the US FDA to Simultaneously Co-Develop Companion Diagnostics (CDx) Delay the Approval of Receptor Tyrosine Kinase Inhibitors for RTK-Rearranged (ROS1-, RET-, AXL-, PDGFR-α-, NTRK1-) Non-Small Cell Lung Cancer Globally?

    PubMed

    Ou, Sai-Hong Ignatius; Soo, Ross A; Kubo, Akihito; Kawaguchi, Tomoya; Ahn, Myung-Ju

    2014-01-01

    The discovery of anaplastic lymphoma kinase (ALK) rearrangement in non-small cell lung cancer (NSCLC) in 2007 and the approval of crizotinib for the treatment of advanced ALK-rearranged NSCLC in 2011 represents a landmark in the development of targeted oncology therapy. The approval of crizotinib was accompanied simultaneously by the approval of the Vysis (Abbott Molecular) break-apart fluorescence in situ hybridization (FISH) test as the companion diagnostic (CDx) test to detect ALK rearrangement. Pfizer, the manufacturer of crizotinib, sponsored the screening of thousands of patients and the standardization of the ALK FISH test as part of the approval process for crizotinib, a first in class ALK inhibitor. Many pharmaceutical companies are now using the Food and Drug Administration (FDA)-approved ALK FISH assay to enroll patients onto trials for their own respective ALK inhibitors. In essence they are "piggybacking" on the FDA-approved ALK FISH assay without having to pay for the development of a CDx, nor screening for ALK-rearranged NSCLC patients in the protocols because screening for ALK rearrangement is now the standard of care in NSCLC after the approval of crizotinib. Since 2007, rearrangement in more receptor tyrosine kinases (RTKs) such as ROS1, RET, AXL, PDGFR-α, and NTRK1 have been discovered in NSCLC but the incidence of each subtype of RTK-rearranged NSCLC is quite rare. Crizotinib has now demonstrated significant clinical activity in ROS1-rearranged NSCLC patients. Whether crizotinib will gain official FDA approval for use in ROS1-rearranged NSCLC, on the other hand, remains unclear as there is no test for ROS1-rearrangement currently being developed to support US FDA approval as a CDx. This may be due in part to the fact that the full cost associated with the development of a pre-market approved-approved CDx must be borne by the company seeking the first drug approval in a new indication. Given the low incidence of ROS1-rearrangement in NSCLC, and

  12. Mini Lessons from FDA.

    ERIC Educational Resources Information Center

    Food and Drug Administration (DHEW), Washington, DC.

    Eight self-contained lessons present information about topics of current interest in the Food and Drug Administration. Multidisciplinary in nature, the lessons can be integrated into ongoing activities in elementary or secondary level reading, math, language arts, social studies, science, art, health, consumer education, and home economics. The…

  13. FDA-Approved HIV Medicines

    MedlinePlus

    ... and acronyms) Brand Name FDA Approval Date Nucleoside Reverse Transcriptase Inhibitors (NRTIs) NRTIs block reverse transcriptase, an enzyme HIV ... AZT, ZDV) Retrovir March 19, 1987 Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) NNRTIs bind to and later alter reverse ...

  14. Leavitt: reforms will improve oversight and openness at FDA.

    PubMed

    2005-01-01

    Health and Human Services Secretary Mike Leavitt says drug safety reforms at the Food and Drug Administration will improve openness and oversight and will enhance the agency's independence. In keeping with this vision, the FDA will create a new independent Drug Safety Oversight Board to oversee the management of drug safety issues and will provide emerging information to doctors and patients about the risks and benefits of medicines. For more information www.fda.gov/cder/drugsafety.htm PMID:16127819

  15. Expediting drug development--the FDA's new "breakthrough therapy" designation.

    PubMed

    Sherman, Rachel E; Li, Jun; Shapley, Stephanie; Robb, Melissa; Woodcock, Janet

    2013-11-14

    The FDA's new "breakthrough therapy" designation for investigational drugs adds to the agency's portfolio of expedited programs for serious conditions. The designation requires preliminary clinical evidence demonstrating substantial improvement over existing therapies. PMID:24224621

  16. FDA panel finds mifepristone safe and effective.

    PubMed

    1996-07-26

    At a July 19 hearing, the Food and Drug Administration's Advisory Committee for Reproductive Health Drugs found mifepristone to be safe and effective in inducing abortions early in pregnancy and recommended that the drug be approved for marketing in the US. With a 6-0 vote with two abstentions, the eight-member panel found that mifepristone's benefits were greater than its risks; agreed, 7-0, with one abstention, that it is safe; voted 6-2 to accept data from a French study as sufficient to recommend use in this country; and decided unanimously to reconvene if results from US clinical trials differ significantly from those from France. While the FDA is not required to follow the panel's advice, it is highly uncommon for it to do otherwise. The advisory panel scheduled the hearing in response to an application filed this spring by the Population Council, the nonprofit organization that owns the US patent rights to the drug. The meeting began with a presentation by the Population Council on the results of an American mifepristone trial that involved more than 2000 women and a discussion of the data from studies and practical use in France. The second session brought public testimony from 33 speakers, the majority of whom spoke in favor of the drug's approval. A company plans to manufacture mifepristone once it is approved but refuses to reveal its identity out of concern that it will be a target for anti-choice protests and boycotts. The drug would be marketed by Advances in Health Technology, Inc., an enterprise designated by the Population Council as the exclusive US distributor of mifepristone--the abortifacient marketed as RU486 in France and used by nearly 200,000 women in Europe and elsewhere. PMID:12347288

  17. Possible FDA-approved drugs to treat Ebola virus infection.

    PubMed

    Yuan, Shu

    2015-01-01

    There is currently no effective treatment for the Ebola virus (EBOV) thus far. Most drugs and vaccines developed to date have not yet been approved for human trials. Two FDA-approved c-AbI1 tyrosine kinase inhibitors Gleevec and Tasigna block the release of viral particles; however, their clinical dosages are much lower than the dosages required for effective EBOV suppression. An α-1,2-glucosidase inhibitor Miglustat has been shown to inhibit EBOV particle assembly and secretion. Additionally, the estrogen receptor modulators Clomiphene and Toremifene prevent membrane fusion of EBOV and 50-90% of treated mice survived after Clomiphene/Toremifene treatments. However, the uptake efficiency of Clomiphene by oral administration is very low. Thus, I propose a hypothetical treatment protocol to treat Ebola virus infection with a cumulative use of both Miglustat and Toremifene to inhibit the virus effectively and synergistically. EBOV infection induces massive apoptosis of peripheral lymphocytes. Also, cytolysis of endothelial cells triggers disseminated intravascular coagulation (DIC) and subsequent multiple organ failures. Therefore, blood transfusions and active treatments with FDA-approved drugs to treat DIC are also recommended. PMID:25984303

  18. FDA-Approved Biosimilar Insulin

    PubMed Central

    2014-01-01

    If a biosimilar insulin is discovered postmarketing to be subpotent, superpotent, or contaminated or the contents mislabeled, it is an adulterated product and must be quarantined for removal including from a patient’s home. Adulterated products could be considered “counterfeit” since they do not meet the original standards established by the FDA. The FDA must establish a method of regularly assaying samples of biosimilar insulin drawn directly from the supply pipeline to help ensure patient safety and evaluate clinical performance. Independent groups without conflict of interest would perform confidential comparison assay. For less than 5 cents per vial/pen, manufacturers could easily support an independent, FDA-recognized, random sample program and create a functional postmarket surveillance system that better protects the public and the manufacturer from undesired outcomes. PMID:25172881

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

    PubMed

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

    2014-10-01

    Specialty drugs are notable among prescription drugs in that they offer the possibility of substantial clinical improvement, come with important risks of adverse events and mortality, can be complex to manufacture or administer, and are usually extremely costly. The Food and Drug Administration (FDA) plays a critical role in ensuring that patients who could benefit from specialty drugs have access to them in a timely fashion. In this article we review the different strategies that the FDA can use to approve and influence the post-approval prescribing of specialty drugs. When specialty drugs show promise in early clinical trials, the FDA can expedite the drugs' availability to patients through expanded access programs and expedited approval pathways that speed regulatory authorization. After approval, to ensure that specialty drugs are directed to the patients who are most likely to benefit from them, the FDA can limit the scope of the drugs' indications, encourage the development of companion diagnostic tests to indicate which patients should receive the drugs, or require that manufacturers subject them to Risk Evaluation and Mitigation Strategies to ensure that their use is appropriately limited to a restricted population that is aware of the drugs' risks and benefits. Implementing these existing regulatory approaches can promote timely patient access to specialty drugs while preventing expensive and potentially inappropriate overuse. PMID:25288421

  20. FDA regulation of labeling and promotional claims in therapeutic color vision devices: a tutorial.

    PubMed

    Drum, Bruce

    2004-01-01

    The Food and Drug Administration (FDA) is responsible for determining whether medical device manufacturers have provided reasonable assurance, based on valid scientific evidence, that new devices are safe and effective for their intended use before they are introduced into the U.S. market. Most existing color vision devices pose so little risk that their manufacturers are not required to submit a premarket notification [510(k)] to FDA prior to market. However, even low-risk devices may not be acceptable if they are marketed on the basis of misleading or excessive claims. Although most color vision devices are diagnostic, two types that are therapeutic rather than diagnostic are colored lenses intended to improve deficient color vision and colored lenses intended to improve reading performance. Both of these devices have presented special regulatory challenges to FDA because the intended uses and effectiveness claims initially proposed by the manufacturers were not supported by valid scientific evidence. In each instance, however, FDA worked with the manufacturer to restrict labeling and promotional claims in ways that were consistent with the available device performance data and that allowed for the legal marketing of the device. PMID:15518230

  1. Safety monitoring of drugs granted exclusivity under the Best Pharmaceuticals for Children Act: what the FDA has learned.

    PubMed

    Mathis, L L; Iyasu, S

    2007-08-01

    The Best Pharmaceuticals for Children Act (BPCA) was signed into law on 4 January 2002, shortly after the pediatric exclusivity provision of the Food and Drug Administration (FDA) Modernization Act expired on 1 January 2002. This Act provides six months of marketing exclusivity for a drug when a pharmaceutical company studies that drug for use in the pediatric population as requested by the FDA. Section 17 of the BPCA specifically requires that the FDA review all adverse events reported for drugs that receive pediatric exclusivity. In most of the cases, no unexpected adverse events were reported in the pediatric population; however, in some cases, this focused safety review provided information important to the safety of medication use in children. PMID:17632537

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

    PubMed

    O'Reilly, James T

    2009-01-01

    Upwards of 400,000 Americans will die that year from the effects of cigarettes, which FDA will now "regulate" very gently, with its hands tied by a slick statutory protection for the largest existing tobacco marketers. Career FDA professionals will be criticized as enablers of mega-marketers' continued sales, working at the margins, arranging the paperwork for protection of megafirms' market share, and sitting by as the deaths and addictive behaviors continue. "Join the Public Health Service, inspired by a public health mission," they were told, and yet they will be unable to do much regulating of the addictive and fatal products for which they now have titular responsibility. This essay observes that these fine FDA professionals are handed the sticky remains of a messy bargain, negotiated in a distracted Congress by expensive lawyers with clients who were potent contributors to political action committees. The only formula that is not secret about the 2009 law is the way in which industry purchased sufficient allegiance to gather the votes for its adoption. The remaining mystery is how FDA could be expected to do these tasks without losing its best and brightest professionals to other fields. PMID:19999639

  3. 77 FR 14401 - Draft Guidance on Drug Safety Information-FDA's Communication to the Public; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... Federal Register of March 7, 2007 (72 FR 10224), FDA announced the availability of a guidance titled... HUMAN SERVICES Food and Drug Administration Draft Guidance on Drug Safety Information--FDA's Communication to the Public; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice....

  4. 25 CFR 23.41 - Uniform grant administration provisions, requirements and applicability.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... INDIAN CHILD WELFARE ACT General and Uniform Grant Administration Provisions and Requirements § 23.41... administration provisions and requirements specified at 25 CFR part 276 and under this subpart are applicable...

  5. 25 CFR 23.41 - Uniform grant administration provisions, requirements and applicability.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... INDIAN CHILD WELFARE ACT General and Uniform Grant Administration Provisions and Requirements § 23.41... administration provisions and requirements specified at 25 CFR part 276 and under this subpart are applicable...

  6. 25 CFR 23.41 - Uniform grant administration provisions, requirements and applicability.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... INDIAN CHILD WELFARE ACT General and Uniform Grant Administration Provisions and Requirements § 23.41... administration provisions and requirements specified at 25 CFR part 276 and under this subpart are applicable...

  7. 25 CFR 23.41 - Uniform grant administration provisions, requirements and applicability.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... INDIAN CHILD WELFARE ACT General and Uniform Grant Administration Provisions and Requirements § 23.41... administration provisions and requirements specified at 25 CFR part 276 and under this subpart are applicable...

  8. Point-Counterpoint: The FDA Has a Role in Regulation of Laboratory-Developed Tests.

    PubMed

    Caliendo, Angela M; Hanson, Kimberly E

    2016-04-01

    Since the Food and Drug Administration (FDA) released its draft guidance on the regulation of laboratory-developed tests (LDTs) in October 2014, there has been a flurry of responses from commercial and hospital-based laboratory directors, clinicians, professional organizations, and diagnostic companies. The FDA defines an LDT as an "in vitrodiagnostic device that is intended for clinical use and is designed, manufactured, and used within a single laboratory." The draft guidance outlines a risk-based approach, with oversight of high-risk and moderate-risk tests being phased in over 9 years. High-risk tests would be regulated first and require premarket approval. Subsequently, moderate-risk tests would require a 510(k) premarket submission to the FDA and low-risk tests would need only to be registered. Oversight discretion would be exercised for LDTs focused on rare diseases (defined as fewer than 4,000 tests, not cases, per year nationally) and unmet clinical needs (defined as those tests for which there is no alternative FDA-cleared or -approved test). There was an open comment period followed by a public hearing in early January of 2015, and we are currently awaiting the final decision regarding the regulation of LDTs. Given that LDTs have been developed by many laboratories and are essential for the diagnosis and monitoring of an array of infectious diseases, changes in their regulation will have far-reaching implications for clinical microbiology laboratories. In this Point-Counterpoint, Angela Caliendo discusses the potential benefits of the FDA guidance for LDTs whereas Kim Hanson discusses the concerns associated with implementing the guidance and why these regulations may not improve clinical care. PMID:26791369

  9. FDA perspectives on health claims for food labels.

    PubMed

    Rowlands, J Craig; Hoadley, James E

    2006-04-01

    The U.S. Food and Drug Administration's regulatory authority over health claims was clarified in 1990 legislation known as the Nutrition Labeling and Education Act (NLEA). This law established mandatory nutrition labeling for most foods and placed restrictions on the use of food label claims characterizing the levels or health benefits of nutrients in foods. NLEA set a high threshold for the scientific standard under which the U.S. Food and Drug Administration (FDA) may authorize health claims, this standard is known as the significant scientific agreement (SSA) standard. Subsequent legislation known as the Food and Drug Administration Modernization Act (FDAMA) provided an alternative to FDA review of the health claim where an U.S. government scientific body other than FDA concluded that there is SSA for a substance/disease relationship. Courts have since extended the scope of health claims to include qualified health claims (QHC) that are health claims not substantiated on evidence that meets the level of SSA standard, but include a qualifying statement intended to convey to the consumer the level of evidence for the claim. FDA has responded by developing an evidence-based ranking system for scientific data to determine the level of evidence substantiating a health claim. The following is an overview of FDA's regulations and evidence-based method for evaluating health claims. PMID:16480811

  10. FDA's regulation of tanning beds: how much heat?

    PubMed

    Knapp, Veronica

    2011-01-01

    This paper considers the problem of indoor tanning bed use by teenagers. The paper explores FDA's current authority to regulate tanning lamps as Class I medical devices, concluding that FDA's authority is poorly tailored to affect teenagers' repeated use of these products. An outright ban is unlikely; therefore, the best available options are to regulate access by minors and to amend the warning label requirements to reflect the current state of knowledge about the risks of tanning bed use. PMID:24505845

  11. 76 FR 737 - Tobacco Products, Exemptions From Substantial Equivalence Requirements

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-06

    ...The Food and Drug Administration (FDA) is issuing this proposed rule to establish procedures for requesting an exemption from the substantial equivalence requirements of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The proposed rule would describe the process and statutory criteria for requesting an exemption and explain how FDA would review requests for......

  12. 30 CFR 886.18 - What audit and administrative requirements must I meet?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 3 2010-07-01 2010-07-01 false What audit and administrative requirements must... INDIAN TRIBES § 886.18 What audit and administrative requirements must I meet? (a) You must comply with the audit requirements of the OMB Circular A-133. (b) You must follow administrative...

  13. 42 CFR 441.615 - Administration fee requirements.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ..., a provider who administers a qualified pediatric vaccine to a federally vaccine-eligible child, may... administration of a qualified pediatric vaccine as long as the fee does not exceed the costs of the... provider may not deny administration of a qualified pediatric vaccine to a vaccine-eligible child due...

  14. 45 CFR 1336.50 - Financial and administrative requirements.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION FOR NATIVE AMERICANS, NATIVE... part: 45 CFR Part 16Department grant appeals process. 45 CFR Part 46Protection of human subjects. 45 CFR Part 74Administration of grants. 45 CFR Part 75Informal grant appeals procedures (indirect...

  15. 45 CFR 1336.50 - Financial and administrative requirements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION FOR NATIVE AMERICANS, NATIVE... part: 45 CFR Part 16Department grant appeals process. 45 CFR Part 46Protection of human subjects. 45 CFR Part 74Administration of grants. 45 CFR Part 75Informal grant appeals procedures (indirect...

  16. 45 CFR 1336.50 - Financial and administrative requirements.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION FOR NATIVE AMERICANS, NATIVE... part: 45 CFR Part 16Department grant appeals process. 45 CFR Part 46Protection of human subjects. 45 CFR Part 74Administration of grants. 45 CFR Part 75Informal grant appeals procedures (indirect...

  17. 76 FR 62073 - Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-06

    ... (76 FR 45820), FDA published a notice establishing fee rates for FY 2012 for domestic and foreign... Provisions of the FDA Food Safety Modernization Act; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Implementation of the Fee Provisions of Section 107 of the FDA Food...

  18. 24 CFR 401.302 - PRA administrative requirements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Development (Continued) OFFICE OF HOUSING AND OFFICE OF MULTIFAMILY HOUSING ASSISTANCE RESTRUCTURING, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT MULTIFAMILY HOUSING MORTGAGE AND HOUSING ASSISTANCE RESTRUCTURING PROGRAM (MARK-TO-MARKET) Participating Administrative Entity (PAE) and Portfolio Restructuring...

  19. FDA moves to permit oral contraceptive prescriptions without initial pelvic exam.

    PubMed

    1993-05-28

    The Planned Parenthood Federation of America (PPFA) submitted recommendations to the US Food and Drug Administration's (FDA) Fertility and Maternal Health Drugs Advisory Committee. The PPFA wanted the FDA to remove requirements for a pelvic examination and blood tests before an oral contraceptive (OC) is prescribed. Two representatives of the Family Planning Council of Southeastern Pennsylvania told the FDA advisory committee about the evaluation results of its Smart Start program. 23% of teenagers wanting to use OCs opted to delay the pelvic examination, and 40% opted to delay the blood tests. 83% of these same teenagers were already sexually active. 69% returned for pelvic exams at 3 months. Increased education and counseling over several sessions probably explained why more study participants used condoms and fewer of them became pregnant during the 6-month study. Physicians from the American College of Obstetricians and Gynecologists and the American Fertility Society also attended the committee hearing and supported PPFA's recommendations. The National Women's Health Network wanted to delay the discussion until the committee could also address the sale of OCs over-the-counter. The statements convinced the committee to allow physicians to defer to full physical examination as long as there are no contraindications. This May 20, 1993 approval emphasized the need for physicians to continue taking a complete medical history and conducting other tests that may uncover contraindications (e.g. pregnancy and blood pressure). FDA staff now must write the exact language needed for the OC labeling change to be approved by the FDA commissioner. PMID:12286460

  20. 21 CFR 14.15 - Committees working under a contract with FDA.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Committees working under a contract with FDA. 14.15 Section 14.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE General Provisions § 14.15 Committees working under a contract with FDA. (a) FDA may...

  1. 21 CFR 14.15 - Committees working under a contract with FDA.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Committees working under a contract with FDA. 14.15 Section 14.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE General Provisions § 14.15 Committees working under a contract with FDA. (a) FDA may...

  2. 45 CFR 97.16 - What fiscal, matching and administrative requirements apply to grantees?

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 1 2010-10-01 2010-10-01 false What fiscal, matching and administrative requirements apply to grantees? 97.16 Section 97.16 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION CONSOLIDATION OF GRANTS TO THE INSULAR AREAS § 97.16 What fiscal, matching and administrative requirements apply to grantees?...

  3. 21 CFR 107.200 - Food and Drug Administration-required recall.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Food and Drug Administration-required recall. 107... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA Infant Formula Recalls § 107.200 Food and Drug Administration-required recall. When the Food and Drug Administration determines that...

  4. 21 CFR 107.200 - Food and Drug Administration-required recall.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Food and Drug Administration-required recall. 107... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA Infant Formula Recalls § 107.200 Food and Drug Administration-required recall. When the Food and Drug Administration determines that...

  5. 21 CFR 107.200 - Food and Drug Administration-required recall.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Food and Drug Administration-required recall. 107... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA Infant Formula Recalls § 107.200 Food and Drug Administration-required recall. When the Food and Drug Administration determines that...

  6. 21 CFR 107.200 - Food and Drug Administration-required recall.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Food and Drug Administration-required recall. 107... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA Infant Formula Recalls § 107.200 Food and Drug Administration-required recall. When the Food and Drug Administration determines that...

  7. 21 CFR 107.200 - Food and Drug Administration-required recall.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Food and Drug Administration-required recall. 107... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA Infant Formula Recalls § 107.200 Food and Drug Administration-required recall. When the Food and Drug Administration determines that...

  8. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT... from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office in determining whether a patent related to a product is eligible for patent term restoration as follows:...

  9. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT... from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office in determining whether a patent related to a product is eligible for patent term restoration as follows:...

  10. FDA Boxed Warning for Immediate-Release Opioids.

    PubMed

    Food And Drug Administration Public Health Service U S Department Of Health And Human Services

    2016-06-01

    On March 22, 2016, the Food and Drug Administration (FDA) announced enhanced warnings for immediate-release opioid pain medications related to risks of misuse, abuse, addiction, overdose, and death. The new safety warnings also added to all prescription opioid medications to inform prescribers and patients of additional risks related to opioid use. PMID:27301692

  11. 21 CFR 316.34 - FDA recognition of exclusive approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Section 316.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE ORPHAN DRUGS Orphan-drug Exclusive Approval § 316.34 FDA recognition of... written notice recognizing exclusive approval once the marketing application for a designated...

  12. FDA Approves New Weight-Loss Device

    MedlinePlus

    ... gov/news/fullstory_159362.html FDA Approves New Weight-Loss Device Surgically implanted port allows obese patients to ... have been unable to lose weight and maintain weight loss using nonsurgical treatments. The FDA approval is for ...

  13. FDA Warns About Stem Cell Claims

    MedlinePlus

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

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

    PubMed

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

    2009-01-01

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

  15. 7 CFR 272.4 - Program administration and personnel requirements.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... current standards for a merit system of personnel administration or any standards later prescribed by the... system personnel in the interview and certification process are specified in § 273.2(k) for SSI..., tapes, or similar memory devices. The issuance unit shall provide certified households with...

  16. 7 CFR 272.4 - Program administration and personnel requirements.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... current standards for a merit system of personnel administration or any standards later prescribed by the... system personnel in the interview and certification process are specified in § 273.2(k) for SSI..., tapes, or similar memory devices. The issuance unit shall provide certified households with...

  17. 45 CFR 1336.50 - Financial and administrative requirements.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... AMERICAN PROGRAMS NATIVE AMERICAN PROGRAMS Financial Assistance Provisions § 1336.50 Financial and... part: 45 CFR Part 16Department grant appeals process. 45 CFR Part 46Protection of human subjects. 45 CFR Part 74Administration of grants. 45 CFR Part 75Informal grant appeals procedures (indirect...

  18. Consolidating medical staff and administrative requirements eliminates potential problems.

    PubMed

    Hershey, N

    1980-11-01

    If policies and procedures relative to a single function are scattered among hospital documents, the potential for conflict and inconsistency between administration and medical staff is enhanced. Incorporation in one reference source can help clarify responsibilities and facilitate conformity. PMID:10248580

  19. 77 FR 70955 - FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-28

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 15 FDA Actions Related to Nicotine Replacement... Tobacco Dependence; Public Hearing; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public hearing; request for comments. SUMMARY: The Food and Drug Administration (FDA)...

  20. Medical devices; medical device distributor reporting--FDA. Final rule; notification of status under the Safe Medical Devices Act; confirmation of effective date.

    PubMed

    1993-09-01

    The Food and Drug Administration (FDA) is announcing that the tentative final rule on medical device distributor reporting that appeared in the Federal Register of November 26, 1991 (56 FR 60024), is now a final rule by operation of law. This final rule requires distributors to submit reports to FDA and to manufacturers, of deaths, serious illnesses, and serious injuries related to medical devices and to submit reports to manufacturers of certain malfunctions that may cause a death, serious illness, or serious injury, if the malfunction were to recur. The final rule also changes the reporting standard for certain distributors that are importers, and changes the definition of the term "serious injury" to conform to a recent statutory amendment. In issuing this final rule, FDA is announcing that the tentative final rule relating to adverse event reporting requirements for distributors, including importers, has the status of a final rule, as of May 28, 1992, by operation of law under the Safe Medical Devices Act of 1990 (the SMDA), as amended by the Medical Device Amendments of 1992 (the 1992 amendments), and is setting forth the regulations reflecting those requirements. FDA is also amending the regulations, based on consideration of comments on the November 26, 1991, tentative final rule, to require distributors to register their facilities and to list their devices with FDA. PMID:10128335

  1. A tale of two transparency attempts at FDA.

    PubMed

    Tai, Laurence

    2013-01-01

    This Article describes and evaluates two elements of the FDA's recent operations implicating information transparency: the Transparency Initiative and a reduction in the agency's FOIA backlog. After discussing the legal context for information disclosure at the FDA and these two transparency attempts, this Article identifies two reasons that the first has fallen short of expectations compared to the second: unlike the reduction in the FOIA backlog, the Transparency Initiative had legal constraints that it did not adequately address, along with political appointee leadership. These principles may be more generally useful for understanding how to stimulate institutional change in administrative agencies. PMID:24552081

  2. Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; policies, requirements, and administrative procedures; delay of effective date. Final rule; delay of effective date.

    PubMed

    2004-02-23

    The Food and Drug Administration (FDA) is further delaying, until December 1, 2006, the effective date of certain requirements of a final rule published in the Federal Register of December 3, 1999 (64 FR 67720). In the Federal Register of May 3, 2000 (65 FR 25639), the agency delayed until October 1, 2001, the effective date of certain requirements in the final rule relating to wholesale distribution of prescription drugs by distributors that are not authorized distributors of record, and distribution of blood derivatives by entities that meet the definition of a "health care entity" in the final rule. The agency further delayed the effective date of these requirements in three subsequent Federal Register notices. Most recently, in the Federal Register of January 31, 2003 (68 FR 4912), FDA delayed the effective date until April 1, 2004. This action further delays the effective date of these requirements until December 1, 2006. The final rule implements the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA), and the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The agency is taking this action to address concerns about the requirements in the final rule raised by affected parties. As explained in the SUPPLEMENTARY INFORMATION section, FDA is working with stakeholders through its counterfeit drug initiative to facilitate widespread, voluntary adoption of track and trace technologies that will generate a de facto electronic pedigree, including prior transaction history back to the original manufacturer, as a routine course of business. If this technology is widely adopted, it is expected to help fulfill the pedigree requirements of the PDMA and obviate or resolve many of the concerns that have been raised with respect to the final rule by ensuring that an electronic pedigree travels with a drug product at all times. Therefore, it is necessary to delay the effective date of Sec

  3. The FDA's failure to address the lack of generalisability of antidepressant efficacy trials in product labelling.

    PubMed

    Zimmerman, Mark

    2016-06-01

    According to the US Food and Drug Administration's (FDA's) regulations, the criteria used to select patients into registration studies should be addressed in a product's label. The FDA's labelling guidelines, which specifically indicate that the routine exclusion of patients of a certain level of severity should be noted in the label, has been uniformly ignored. PMID:27251690

  4. FDA Procedures for Standardization and Certification of Retail Food Inspection/Training Officers, 2000.

    ERIC Educational Resources Information Center

    Food and Drug Administration (DHHS/PHS), Rockville, MD.

    This document provides information, standards, and behavioral objectives for standardization and certification of retail food inspection personnel in the Food and Drug Administration (FDA). The procedures described in the document are based on the FDA Food Code, updated to reflect current Food Code provisions and to include a more refined focus on…

  5. 78 FR 36194 - Draft Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-17

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System'' dated June 2013.......

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

    PubMed

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

    2012-12-01

    Treatment of chronic wounds can present a challenge, with many patients remaining refractory to available advanced therapies. As such, there is a strong need for the development of new products. Unfortunately, despite this demand, few new wound-related drugs have been approved over the past decade. This is in part due to unsuccessful clinical trials and subsequent lack of Food and Drug Administration (FDA) approval. In this article, we discuss the FDA approval process, how it relates to chronic wound trials, common issues that arise, and how best to manage them. Additionally, problems encountered specific to diabetic foot ulcers (DFU) and venous leg ulcers (VLU) are addressed. Careful construction of a clinical trial is necessary in order to achieve the best possible efficacy outcomes and thereby, gain FDA approval. How to design an optimal trial is outlined. PMID:23063664

  7. Healthy public relations: the FDA's 1930s legislative campaign.

    PubMed

    Kay, G

    2001-01-01

    In this article, I argue that the Food and Drug Administration (FDA) is an oft-overlooked government agency that acts to preserve and secure the public's health. From its early years as an agency charged with enforcement of the 1906 Pure Food and Drugs Act, the FDA not only protected the public's health but also made the public aware of its mission, using methods as diverse as displays at county fairs and at the 1933 Chicago World's Fair, radio programming, and active correspondence. The agency encouraged the public to protect itself, particularly in those arenas in which the FDA had no regulatory authority. In addition, it may have overstepped its boundaries when it actively solicited public support for a bill submitted to Congress in the early 1930s. In the dark days of the Great Depression, the FDA contended not only with limited resources and its own feelings of inadequacy in terms of what could and could not be done to protect the populace, but also with "guinea pig" books that horrified and angered many readers. By 1938, when the agency prevailed and the revisions to the 1906 Act passed Congress and were signed into law by President Franklin D. Roosevelt, the FDA had done all that a responsible public health agency should do, and more. PMID:11568487

  8. Are Special Administrative Skills Required in the Community College Administrators' Relations with the Minority Constituencies?

    ERIC Educational Resources Information Center

    Kirkpatrick, Malcolm

    To be effective in dealing with minority constituencies, the community college administrator needs special personality traits and communication skills: he/she must be tough-minded, articulate, aware of different life-styles, and empathetic; he/she should be able to withstand criticism, confront problems directly, accept compromise, and tolerate…

  9. 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

    , 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.

  10. 21 CFR 1000.60 - Recommendation on administratively required dental x-ray examinations.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... x-ray examinations. 1000.60 Section 1000.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Recommendations § 1000.60 Recommendation on administratively required dental x-ray examinations. (a) The Food and Drug Administration recommends that dental x-ray examinations be performed only after...

  11. 21 CFR 1000.60 - Recommendation on administratively required dental x-ray examinations.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... x-ray examinations. 1000.60 Section 1000.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Recommendations § 1000.60 Recommendation on administratively required dental x-ray examinations. (a) The Food and Drug Administration recommends that dental x-ray examinations be performed only after...

  12. 21 CFR 1000.60 - Recommendation on administratively required dental x-ray examinations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... x-ray examinations. 1000.60 Section 1000.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Recommendations § 1000.60 Recommendation on administratively required dental x-ray examinations. (a) The Food and Drug Administration recommends that dental x-ray examinations be performed only after...

  13. 21 CFR 1000.60 - Recommendation on administratively required dental x-ray examinations.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... x-ray examinations. 1000.60 Section 1000.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Recommendations § 1000.60 Recommendation on administratively required dental x-ray examinations. (a) The Food and Drug Administration recommends that dental x-ray examinations be performed only after...

  14. 21 CFR 1000.60 - Recommendation on administratively required dental x-ray examinations.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... x-ray examinations. 1000.60 Section 1000.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Recommendations § 1000.60 Recommendation on administratively required dental x-ray examinations. (a) The Food and Drug Administration recommends that dental x-ray examinations be performed only after...

  15. 45 CFR 235.50 - State plan requirements for methods of personnel administration.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 2 2010-10-01 2010-10-01 false State plan requirements for methods of personnel administration. 235.50 Section 235.50 Public Welfare Regulations Relating to Public Welfare OFFICE OF FAMILY ASSISTANCE (ASSISTANCE PROGRAMS), ADMINISTRATION FOR CHILDREN AND FAMILIES, DEPARTMENT OF HEALTH AND HUMAN SERVICES ADMINISTRATION...

  16. 45 CFR 235.50 - State plan requirements for methods of personnel administration.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 2 2011-10-01 2011-10-01 false State plan requirements for methods of personnel administration. 235.50 Section 235.50 Public Welfare Regulations Relating to Public Welfare OFFICE OF FAMILY ASSISTANCE (ASSISTANCE PROGRAMS), ADMINISTRATION FOR CHILDREN AND FAMILIES, DEPARTMENT OF HEALTH AND HUMAN SERVICES ADMINISTRATION...

  17. 77 FR 6463 - Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-08

    ...The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of January 3, 2012. In the Federal Register of January 3, 2012, FDA published a final rule entitled ``Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma,'' which provided incorrect publication information regarding a 60-day notice that announced the......

  18. 76 FR 10908 - Draft Guidance for Industry on Medication Guides-Distribution Requirements and Inclusion of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-28

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Medication Guides--Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS).'' This draft guidance addresses two topics pertaining to Medication Guides for drug and biological products. First, the draft guidance addresses when FDA intends to......

  19. 44 CFR 208.64 - Administrative and audit requirements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Sponsoring Agencies and States, requirements for non-Federal audit are contained in 44 CFR 13.26, in accordance with OMB Circular A-133, Audits of States, Local Governments, and Non-Profit Organizations. (b..., DEPARTMENT OF HOMELAND SECURITY DISASTER ASSISTANCE NATIONAL URBAN SEARCH AND RESCUE RESPONSE...

  20. 40 CFR 725.25 - General administrative requirements.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... description of all other data known to or reasonably ascertainable by me as required by 40 CFR 725.160 or 725... submit on paper, the Certification statement in 40 CFR 725.25(b) along with submitter identification and... e-PMN software must be used to print the biotechnology notice submission to be sent to EPA....

  1. 40 CFR 725.25 - General administrative requirements.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... description of all other data known to or reasonably ascertainable by me as required by 40 CFR 725.160 or 725... submit on paper, the Certification statement in 40 CFR 725.25(b) along with submitter identification and... e-PMN software must be used to print the biotechnology notice submission to be sent to EPA....

  2. 40 CFR 725.25 - General administrative requirements.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... description of all other data known to or reasonably ascertainable by me as required by 40 CFR 725.160 or 725... submit on paper, the Certification statement in 40 CFR 725.25(b) along with submitter identification and... e-PMN software must be used to print the biotechnology notice submission to be sent to EPA....

  3. Legal requirements for the prescribing and administration of medicines.

    PubMed

    Griffith, Richard

    2007-10-01

    On the 15th anniversary of the introduction of the Medicinal Products: Prescription by Nurses etc. Act 1992, Richard Griffith reflects on the development of nurse prescribing since the Acts implementation and outlines the current procedures by which district nurses may prescribe, supply or administer medicines to patients and the requirements that must be met in order to do so lawfully. PMID:18073650

  4. 40 CFR 725.25 - General administrative requirements.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... description of all other data known to or reasonably ascertainable by me as required by 40 CFR 725.160 or 725... submit on paper, the Certification statement in 40 CFR 725.25(b) along with submitter identification and... e-PMN software must be used to print the biotechnology notice submission to be sent to EPA....

  5. 40 CFR 725.25 - General administrative requirements.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... attachments appear in the open scientific literature) must be in English. All information submitted must be... description of all other data known to or reasonably ascertainable by me as required by 40 CFR 725.160 or 725... to EPA (via CDX) using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to obtain...

  6. 25 CFR 23.41 - Uniform grant administration provisions, requirements and applicability.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... administration provisions and requirements specified at 25 CFR part 276 and under this subpart are applicable to... applicability. 23.41 Section 23.41 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR HUMAN SERVICES INDIAN CHILD WELFARE ACT General and Uniform Grant Administration Provisions and Requirements §...

  7. 26 CFR 1.7519-2T - Required payments-procedures and administration (temporary).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 26 Internal Revenue 13 2011-04-01 2011-04-01 false Required payments-procedures and administration (temporary). 1.7519-2T Section 1.7519-2T Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES (CONTINUED) The Tax Court § 1.7519-2T Required payments—procedures and administration...

  8. 22 CFR 46.7 - Instructions from the Administrator required in certain cases.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 1 2012-04-01 2012-04-01 false Instructions from the Administrator required in certain cases. 46.7 Section 46.7 Foreign Relations DEPARTMENT OF STATE VISAS CONTROL OF ALIENS DEPARTING FROM THE UNITED STATES § 46.7 Instructions from the Administrator required in certain cases. In...

  9. A National Study of State Credentialing Requirements for Administrators of Special Education

    ERIC Educational Resources Information Center

    Boscardin, Mary Lynn; Weir, Kerry; Kusek, Christopher

    2010-01-01

    Unlike data that show that all states require credentials for special education teachers, national data indicate that only 27 states require licensure/certification/endorsement as an administrator of special education. The titles used by states to identify the local director of special education include administrator of special education, director…

  10. Medical devices; exemption from premarket notification and reserved devices; class I. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-01-14

    The Food and Drug Administration (FDA) is amending its classification regulations to designate class I devices that are exempt from the premarket notification requirements, subject to certain limitations, and to designate those class I devices that remain subject to premarket notification requirements under the new statutory criteria for premarket notification requirements. The devices FDA is designating as exempt do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the FDA Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA. Elsewhere in this issue of the Federal Register, FDA is announcing that it is withdrawing proposed rules to revoke existing exemptions from premarket notification for two devices. PMID:11010655

  11. FDA: 2 Diabetes Drugs May Be Linked to Heart Failure Risk

    MedlinePlus

    ... nih.gov/medlineplus/news/fullstory_158144.html FDA: 2 Diabetes Drugs May Be Linked to Heart Failure ... Food and Drug Administration said. People with type 2 diabetes who use these drugs should not stop ...

  12. 21 CFR 1.405 - When does FDA have to issue a decision on an appeal?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption What Is the Appeal Process for A Detention Order? § 1.405 When does FDA have to issue a...

  13. Young LGBT Adults Are Target of FDA Stop-Smoking Campaign

    MedlinePlus

    ... Young LGBT Adults Are Target of FDA Stop-Smoking Campaign Tobacco use is common among these 18- ... and Drug Administration has launched an LGBT stop-smoking campaign. "We know LGBT young adults in this ...

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

    PubMed Central

    Rising, Joshua P.; Moscovitch, Ben

    2015-01-01

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

  15. Establishment, maintenance, and availability of records: amendment to record availability requirements. Final rule.

    PubMed

    2014-04-01

    The Food and Drug Administration (FDA) is issuing a final regulation that adopts, without change, the interim final rule (IFR) entitled "Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements.'' This final rule affirms the IFR's change to FDA's records access as required by the FDA Food Safety Modernization Act (FSMA). Prior to the passage of FSMA, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) provided the Secretary (by delegation FDA) with access to records relating to food that FDA reasonably believes to be adulterated and presents a threat of serious adverse health consequences or death to humans or animals. The FSMA amendment expands FDA's former records access authority beyond records relating to the specific suspect article of food to include records relating to any other article of food that FDA reasonably believes is likely to be affected in a similar manner. In addition, the FSMA amendment permits FDA to access records relating to articles of food for which FDA believes that there is a reasonable probability that the use of or exposure to the article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals. This final rule does not make any changes to the regulatory requirements established by the IFR. The final regulation also responds to comments submitted in response to the request for comments in the IFR. PMID:24716304

  16. US FDA oncology drug approvals in 2014.

    PubMed

    Wolford, Juliet E; Tewari, Krishnansu S

    2015-01-01

    Cancer is a close second to heart disease for cause of death in the USA, and could soon surpass heart disease as the population ages and the incidence of cancer continues to increase. While heart disease can be addressed through behavior modification and education (e.g., smoking cessation, dietary changes, exercises that promote cardiovascular fitness), pharmacology and improved surgical devices and methods, cancer ultimately requires improved and novel drug treatments to bring mortality rates down. In 2014, the US FDA approved 17 drugs and/or drug combinations in 12 disease sites for a total of 19 indications in melanoma, hematologic malignancies, gastrointestinal carcinoma, non-small-cell lung cancer, gynecologic malignancies and lymphoma/lymphoproliferative disorders. PMID:26039742

  17. 78 FR 32581 - Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-31

    ...The Food and Drug Administration (FDA or we) is issuing this proposed rule that would require domestic tobacco product manufacturers and importers to submit information needed to calculate the amount of user fees assessed under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The United States Department of Agriculture (USDA) has been collecting this information and providing FDA with......

  18. Form for reporting serious adverse events and product problems with human drug and biological products and devices; availability--FDA. Notice.

    PubMed

    1993-06-01

    The Food and Drug Administration (FDA) is announcing the availability of a new form for reporting adverse events and product problems with human drug products, biologic products, medical devices (including in-vitro diagnostics), special nutritional products (dietary supplements, medical foods, infant formulas), and other products regulated by FDA. There are two versions of the form. One version of the form (FDA Form 3500) is available for use by health professionals for voluntary reporting; the other version of the form (FDA Form 3500A) is to be used by user facilities, distributors, and manufacturers for reporting that is required by statute or FDA regulations. The new form will simplify and consolidate the reporting of adverse events and product problems and will enhance agency-wide consistency in the collection of postmarketing data. This notice also responds to written comments the agency received on proposed versions of this form. Copies of both versions of the new form appear at the end of this document. PMID:10171452

  19. Contrary Signals from the FDA.

    ERIC Educational Resources Information Center

    Meyer, Katherine A.; Schultz, William B.

    1984-01-01

    The Reagan administration has taken numerous regulatory actions which are flatly inconsistent with the President's stated political philosophy. Nowhere is this more evident than at the Food and Drug Administration in areas concerning abortion, generic drugs, the denial of information, and medical devices. (RM)

  20. 30 CFR 885.18 - What audit, accounting, and administrative requirements must I meet?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... accounting, payment, records, property, and management contained in 43 CFR part 12. ... 30 Mineral Resources 3 2013-07-01 2013-07-01 false What audit, accounting, and administrative... TRIBES § 885.18 What audit, accounting, and administrative requirements must I meet? (a) You must...

  1. 30 CFR 885.18 - What audit, accounting, and administrative requirements must I meet?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... accounting, payment, records, property, and management contained in 43 CFR part 12. ... 30 Mineral Resources 3 2011-07-01 2011-07-01 false What audit, accounting, and administrative... TRIBES § 885.18 What audit, accounting, and administrative requirements must I meet? (a) You must...

  2. 30 CFR 885.18 - What audit, accounting, and administrative requirements must I meet?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... accounting, payment, records, property, and management contained in 43 CFR part 12. ... 30 Mineral Resources 3 2014-07-01 2014-07-01 false What audit, accounting, and administrative... TRIBES § 885.18 What audit, accounting, and administrative requirements must I meet? (a) You must...

  3. 30 CFR 885.18 - What audit, accounting, and administrative requirements must I meet?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... accounting, payment, records, property, and management contained in 43 CFR part 12. ... 30 Mineral Resources 3 2010-07-01 2010-07-01 false What audit, accounting, and administrative... TRIBES § 885.18 What audit, accounting, and administrative requirements must I meet? (a) You must...

  4. 30 CFR 885.18 - What audit, accounting, and administrative requirements must I meet?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... accounting, payment, records, property, and management contained in 43 CFR part 12. ... 30 Mineral Resources 3 2012-07-01 2012-07-01 false What audit, accounting, and administrative... TRIBES § 885.18 What audit, accounting, and administrative requirements must I meet? (a) You must...

  5. 25 CFR 700.477 - Administration of financial assistance and recordkeeping requirements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 25 Indians 2 2010-04-01 2010-04-01 false Administration of financial assistance and recordkeeping... OPERATIONS AND RELOCATION PROCEDURES Discretionary Funds § 700.477 Administration of financial assistance and... requirements; and (2) Federal Management Circular 74-4 5 CFR part 1310, entitled “Cost Principles Applicable...

  6. 75 FR 30038 - Office of Administration; Matching Requirements on Grants Awarded Under Children's Bureau Funding...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-28

    ...The Administration for Children and Families (ACF) hereby gives notice to the public that the following program within the Agency will administratively impose a matching requirement on grants awarded under the following program title and funding opportunity announcement for Fiscal Year...

  7. 24 CFR 1003.501 - Applicability of uniform administrative requirements and cost principles.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... following provisions of 24 CFR part 84 “Uniform Administrative Requirements for Grants and Agreements With... the grant period as defined in 24 CFR 85.25, the proceeds shall be program income; and (ii) Equipment... TRIBES AND ALASKA NATIVE VILLAGES Grant Administration § 1003.501 Applicability of uniform...

  8. 24 CFR 1003.501 - Applicability of uniform administrative requirements and cost principles.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... following provisions of 24 CFR part 84 “Uniform Administrative Requirements for Grants and Agreements With... the grant period as defined in 24 CFR 85.25, the proceeds shall be program income; and (ii) Equipment... TRIBES AND ALASKA NATIVE VILLAGES Grant Administration § 1003.501 Applicability of uniform...

  9. 24 CFR 1003.501 - Applicability of uniform administrative requirements and cost principles.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... following provisions of 24 CFR part 84 “Uniform Administrative Requirements for Grants and Agreements With... the grant period as defined in 24 CFR 85.25, the proceeds shall be program income; and (ii) Equipment... TRIBES AND ALASKA NATIVE VILLAGES Grant Administration § 1003.501 Applicability of uniform...

  10. 24 CFR 1003.501 - Applicability of uniform administrative requirements and cost principles.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... following provisions of 24 CFR part 84 “Uniform Administrative Requirements for Grants and Agreements With... the grant period as defined in 24 CFR 85.25, the proceeds shall be program income; and (ii) Equipment... TRIBES AND ALASKA NATIVE VILLAGES Grant Administration § 1003.501 Applicability of uniform...

  11. 29 CFR 2590.606-4 - Notice requirements for plan administrators.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 29 Labor 9 2013-07-01 2013-07-01 false Notice requirements for plan administrators. 2590.606-4 Section 2590.606-4 Labor Regulations Relating to Labor (Continued) EMPLOYEE BENEFITS SECURITY ADMINISTRATION, DEPARTMENT OF LABOR GROUP HEALTH PLANS RULES AND REGULATIONS FOR GROUP HEALTH PLANS Continuation Coverage, Qualified Medical Child...

  12. 45 CFR 1336.69 - Reporting requirements: Responsibilities of the Loan Administrator.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 4 2010-10-01 2010-10-01 false Reporting requirements: Responsibilities of the Loan Administrator. 1336.69 Section 1336.69 Public Welfare Regulations Relating to Public Welfare (Continued) OFFICE OF HUMAN DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION FOR NATIVE AMERICANS, NATIVE...

  13. Perspective on Advancing FDA Regulatory Monitoring for Mycotoxins in Foods using Liquid Chromatography and Mass Spectrometry (Review).

    PubMed

    Zhang, Kai; Wong, Jon W; Krynitsky, Alexander J; Trucksess, Mary W

    2016-07-01

    The presence of mycotoxins (such as aflatoxins, deoxynivalenol, fumonisins, and patulin) is routinely monitored by the U.S. Food and Drug Administration (FDA) to ensure that their concentrations in food are below the levels requiring regulatory action or advisories. To improve the efficiency of mycotoxin analysis, the researchers at the FDA's Center for Food Safety and Applied Nutrition have been evaluating modern LC-MS technologies. Consequently, a variety of LC-tandem MS and LC-high-resolution MS methods have been developed, which simultaneously identify and quantitate multiple mycotoxins in foods and feeds. Although matrix effects (matrix-induced ion suppression or enhancement) associated with LC-MS-based mycotoxin analysis remain, this review discusses methods for managing these effects and proposes practical solutions for the future implementation of LC-MS-based multimycotoxin analysis. PMID:27330044

  14. 77 FR 18871 - Administrative Guide for Verifying Compliance With Packaging Requirements for Shipment and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ... administrative requirements for transporting licensed material under 10 CFR part 71, ``Packaging and... of Radioactive Material AGENCY: Nuclear Regulatory Commission. ACTION: Regulatory guide; issuance... Receipt of Radioactive Material.'' This regulatory guide describes an approach the staff of the...

  15. Pictorial Health Warnings on Cigarette Packs in the United States: An Experimental Evaluation of the Proposed FDA Warnings

    PubMed Central

    Reid, Jessica L.; Driezen, Pete; Boudreau, Christian

    2013-01-01

    Introduction: In 2010, the U.S. Food and Drug Administration (FDA) developed 36 proposed health warnings for cigarette packages, from which 9 were subsequently selected for implementation. The current study aimed to evaluate the perceived efficacy of the 36 proposed FDA warnings. Methods: Web-based surveys were conducted with 783 adult smokers and 510 youth in United States. Participants were randomized to view and rate two sets of 6–7 warnings, each set corresponding to one of nine health effect statements required under the Tobacco Control Act. Warnings included all 36 FDA-proposed warnings and additional warnings for comparison. Results: Youth and adults rated individual warnings similarly; in all cases where differences were found, youth perceived warnings as more effective. Comparisons on specific elements indicated that warnings were perceived as more effective if they were: full color (vs. black and white), featured real people (vs. comic book style), contained graphic images (vs. nongraphic), and included a telephone “quitline” number or personal information. Few sociodemographic differences were observed in overall perceived effectiveness: younger respondents, non-White respondents, and smokers intending to quit rated warnings higher. Conclusions: Seven of the nine health warnings selected by the FDA for implementation were among the proposed warnings rated as most effective in the current study. However, the warning(s) added for comparison were rated higher than the FDA-selected warning for five of the nine sets, suggesting some warnings could be improved for greater impact. The findings support the inclusion of a telephone “quitline” number and reinforce the importance of depicting “real” people and health effects. PMID:22505660

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

    PubMed

    Welle, Cristin; Krauthamer, Victor

    2012-03-01

    The U.S. Food and Drug Administration (FDA) is charged with assuring the safety and effectiveness of medical devices. Before any medical device can be brought to market, it must comply with all federal regulations regarding FDA processes for clearance or approval. Navigating the FDA regulatory process may seem like a daunting task to the innovator of a novel medical device who has little experience with the FDA regulatory process or device commercialization. This review introduces the basics of the FDA regulatory premarket process, with a focus on issues relating to chronically implanted recording devices in the central or peripheral nervous system. Topics of device classification and regulatory pathways, the use of standards and guidance documents, and optimal time lines for interaction with the FDA are discussed. Additionally, this article summarizes the regulatory research on neural implant safety and reliability conducted by the FDA's Office of Science and Engineering Laboratories (OSEL) in collaboration with Defense Advanced Research Projects Agency (DARPA) Reliable Neural Technology (RE-NET) Program. For a more detailed explanation of the medical device regulatory process, please refer to several excellent reviews of the FDA's regulatory pathways for medical devices [1]-[4]. PMID:22481744

  17. Ensuring that consumers receive appropriate information from drug ads: what is the FDA's role?

    PubMed

    Waxman, Henry A

    2004-01-01

    The promise of direct-to-consumer (DTC) prescription drug advertisements lies in their potential to educate consumers about medical conditions and the possibility of treatment. But this promise can only be fulfilled if consumers are given clear and accurate information. The responsibility for ensuring that this occurs falls on the Food and Drug Administration (FDA). Recent congressional investigations have indicated that the agency is failing at this task, as FDA enforcement actions against false and misleading ads have declined precipitously in recent years. Other FDA efforts, such as its recently released guidelines on prescription drugs, do not appear to be helpful, potentially confusing consumers more than helping them. PMID:15452002

  18. 48 CFR 227.7004 - Requirements for filing an administrative claim for patent infringement.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 3 2011-10-01 2011-10-01 false Requirements for filing an administrative claim for patent infringement. 227.7004 Section 227.7004 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS SYSTEM, DEPARTMENT OF DEFENSE GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS...

  19. 40 CFR 33.302 - Are there any additional contract administration requirements?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... administration requirements? (a) A recipient must require its prime contractor to pay its subcontractor for satisfactory performance no more than 30 days from the prime contractor's receipt of payment from the recipient. (b) A recipient must be notified in writing by its prime contractor prior to any termination of a...

  20. 34 CFR 682.610 - Administrative and fiscal requirements for participating schools.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... participating schools. 682.610 Section 682.610 Education Regulations of the Offices of the Department of... LOAN (FFEL) PROGRAM Requirements, Standards, and Payments for Participating Schools § 682.610 Administrative and fiscal requirements for participating schools. (a) General. Each school shall— (1)...

  1. Drug Advertising and the FDA.

    ERIC Educational Resources Information Center

    Levesque, Cynthia

    With increases in consumer focused advertising for prescription drugs, the Federal Drug Administration has renewed efforts to protect the public from false advertising. In 1982, it charged that the press kits Eli Lilly and Company distributed to reporters on its new antiarthritis drug, Oraflex, misrepresented the product. It recommended that Lilly…

  2. 77 FR 43846 - Food and Drug Administration Pediatric Medical Devices Workshop; Notice of Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-26

    ... Administration's (FDA) Office of Orphan Products Development is announcing the following workshop: FDA Pediatric... Office of Orphan Product Development and will include participants from the FDA's Center for Devices...

  3. FDA Approves Implant to Battle Opioid Addiction

    MedlinePlus

    ... gov/medlineplus/news/fullstory_159050.html FDA Approves Implant to Battle Opioid Addiction Experts say steady dosing ... 26, 2016 (HealthDay News) -- A new long-acting implant that can help treat people addicted to heroin ...

  4. FDA Approves Eye Implant for Aging Boomers

    MedlinePlus

    ... medlineplus/news/fullstory_159648.html FDA Approves Eye Implant for Aging Boomers Tiny lens reshapes cornea to ... 2016 THURSDAY, June 30, 2016 (HealthDay News) -- An implant that helps the aging eye focus on small ...

  5. FDA Approves Eye Implant for Aging Boomers

    MedlinePlus

    ... fullstory_159648.html FDA Approves Eye Implant for Aging Boomers Tiny lens reshapes cornea to improve focus ... 2016 (HealthDay News) -- An implant that helps the aging eye focus on small print and nearby objects ...

  6. Traumatic Brain Injury: FDA Research and Actions

    MedlinePlus

    ... For Consumers Home For Consumers Consumer Updates Traumatic Brain Injury: FDA Research and Actions Share Tweet Linkedin ... top What to Do if You Suspect Traumatic Brain Injury Anyone with signs of moderate or severe ...

  7. FDA Approves First Immunotherapy for Lymphoma

    Cancer.gov

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

  8. FDA Launches Ad Campaign Against Chewing Tobacco

    MedlinePlus

    ... 158385.html FDA Launches Ad Campaign Against Chewing Tobacco Health officials targeting rural teens with messages about health risks of smokeless tobacco products To use the sharing features on this ...

  9. FDA Approves First Fully Dissolvable Stent

    MedlinePlus

    ... fullstory_159721.html FDA Approves First Fully Dissolvable Stent Device is absorbed by the body after about ... July 5, 2016 (HealthDay News) -- The first coronary stent to be gradually absorbed by the body has ...

  10. FDA Bolsters Warnings about Class of Antibiotics

    MedlinePlus

    ... html FDA Bolsters Warnings About Class of Antibiotics Fluoroquinolones such as Cipro, Levaquin should be reserved for ... label warnings on a class of antibiotics called fluoroquinolones because the drugs can lead to disabling side ...

  11. FDA Expands Advice on Statin Risks

    MedlinePlus

    ... of liver damage. back to top Reports of Memory Loss FDA has been investigating reports of cognitive ... included assessments of cognitive function. The reports about memory loss, forgetfulness and confusion span all statin products ...

  12. 21 CFR 4.2 - How does FDA define key terms and phrases in this subpart?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false How does FDA define key terms and phrases in this subpart? 4.2 Section 4.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Combination Products § 4.2 How does FDA define key terms and phrases in this subpart? The terms listed in...

  13. 21 CFR 4.2 - How does FDA define key terms and phrases in this subpart?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false How does FDA define key terms and phrases in this subpart? 4.2 Section 4.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Combination Products § 4.2 How does FDA define key terms and phrases in this subpart? The terms listed in...

  14. 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

  15. 77 FR 52036 - Privacy Act of 1974; Report of a New System of Records; FDA Records Related to Research...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-28

    ... Manager and Address FDA Research Integrity Officer, Office of the Chief Scientist, Food and Drug... Records Related to Research Misconduct Proceedings AGENCY: Food and Drug Administration, HHS. ACTION... Related to Research Misconduct Proceedings, HHS/FDA/OC'' System No. 09-10-0020. Under the Department...

  16. 75 FR 68802 - Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-09

    ...Under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), the Food and Drug Administration (FDA) is required to report annually in the Federal Register on the status of postmarketing requirements and commitments required of, or agreed upon by, holders of approved drug and biological products. This notice is the Agency's report on the status of the studies and......

  17. 21 CFR 320.34 - Requirements for batch testing and certification by the Food and Drug Administration.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... BIOEQUIVALENCE REQUIREMENTS Procedures for Determining the Bioavailability or Bioequivalence of Drug Products... include in the bioequivalence requirement a requirement for manufacturers to submit samples of each batch... and Drug Administration and found to meet the bioequivalence requirement, unless the public...

  18. 21 CFR 320.34 - Requirements for batch testing and certification by the Food and Drug Administration.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... BIOEQUIVALENCE REQUIREMENTS Procedures for Determining the Bioavailability or Bioequivalence of Drug Products... include in the bioequivalence requirement a requirement for manufacturers to submit samples of each batch... and Drug Administration and found to meet the bioequivalence requirement, unless the public...

  19. Medical device; exemption from premarket notification; class II devices; barium enema retention catheters and tips with or without a bag. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-12-01

    The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for barium enema retention catheters and tips with or without a bag with certain limitations. This rule will exempt from premarket notification barium enema retention catheters and tips with or without a bag. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA). PMID:11503724

  20. Revisiting Financial Conflicts of Interest in FDA Advisory Committees

    PubMed Central

    Pham-Kanter, Genevieve

    2014-01-01

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

  1. 21 CFR 60.20 - FDA action on regulatory review period determinations.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... October 9, 1984, in PTO's Official Gazette and as required by 37 CFR chapter I. (b) After determining the... established for the application in FDA's Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm....

  2. 21 CFR 1.378 - What criteria does FDA use to order a detention?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What criteria does FDA use to order a detention? 1.378 Section 1.378 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal...

  3. 21 CFR 1.379 - How long may FDA detain an article of food?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false How long may FDA detain an article of food? 1.379 Section 1.379 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption...

  4. 21 CFR 1271.27 - Will FDA assign me a registration number?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Will FDA assign me a registration number? 1271.27 Section 1271.27 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION HUMAN...

  5. 21 CFR 1271.27 - Will FDA assign me a registration number?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Will FDA assign me a registration number? 1271.27 Section 1271.27 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION HUMAN...

  6. 21 CFR 1.379 - How long may FDA detain an article of food?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false How long may FDA detain an article of food? 1.379 Section 1.379 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption...

  7. 21 CFR 1271.27 - Will FDA assign me a registration number?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Will FDA assign me a registration number? 1271.27 Section 1271.27 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION HUMAN...

  8. Smokers’ and Nonsmokers’ Beliefs About Harmful Tobacco Constituents: Implications for FDA Communication Efforts

    PubMed Central

    2014-01-01

    Introduction: Legislation requires the U.S. Food and Drug Administration (FDA) to release information to the public about harmful constituents in tobacco and tobacco smoke. To inform these efforts, we sought to better understand how smokers and nonsmokers think about tobacco constituents. Methods: In October 2012, 300U.S. adults aged 18–66 years completed a cross-sectional Internet survey. The questions focused on 20 harmful tobacco constituents that the FDA has prioritized for communicating with the public. Results: Most participants had heard of 7 tobacco constituents (ammonia, arsenic, benzene, cadmium, carbon monoxide, formaldehyde, and nicotine), but few participants had heard of the others (e.g., acrolein). Few participants correctly understood that many constituents were naturally present in tobacco. Substances that companies add to cigarette tobacco discouraged people from wanting to smoke more than substances that naturally occur in cigarette smoke (p < .001). Ammonia, arsenic, carbon monoxide, and formaldehyde being in cigarettes elicited the most discouragement from smoking. Constituents elicited greater discouragement from wanting to smoke if respondents were nonsmokers (β = −.34, p < .05), had negative images of smokers (i.e., negative smoker prototypes; β = .19, p < .05), believed constituents are added to tobacco (β = .14, p < .05), or were older (β = .16, p < .05). Conclusions: Our study found low awareness of most tobacco constituents, with greater concern elicited by additives. Efforts to communicate health risks of tobacco constituents should consider focusing on ones that elicited the most discouragement from smoking. PMID:24151139

  9. FDA proposals to limit the hepatotoxicity of paracetamol (acetaminophen): are they reasonable?

    PubMed

    Graham, Garry G; Day, Richard O; Graudins, Andis; Mohamudally, Anthoulla

    2010-04-01

    Hepatotoxicity from paracetamol is of great concern because of the considerable number of patients who develop severe toxicity from this drug. A group of senior medical practitioners, academics and scientists were brought together on June 29 and 30, 2009 by the Food and Drug Administration of USA (FDA) with the aim of providing advice on how to limit the number of cases of hepatotoxicity due to paracetamol in USA. The most contentious recommendations were the reduction in the dose of paracetamol to 650 mg and the elimination of prescription combination products of paracetamol and opiates. The first recommendation indicates that many members of the committee consider, despite much evidence to the contrary, that therapeutic doses of paracetamol (up to 4 g daily) are associated with a significant incidence of hepatotoxicity. The second recommendation, if accepted by FDA, will require major changes in the therapeutic use of paracetamol and opiates. Adoption of these two recommendations may lead to the increased use of NSAIDs with the potential of increasing incidence of NSAIDs-related adverse reactions. PMID:20213329

  10. 24 CFR 1000.26 - What are the administrative requirements under NAHASDA?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... sections of 24 CFR part 85 “Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments.” For purposes of this part, “grantee” as defined in 24 CFR part 85 has the... 24 Housing and Urban Development 4 2011-04-01 2011-04-01 false What are the...

  11. 34 CFR 403.186 - What are the administrative cost requirements applicable to a State?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... APPLIED TECHNOLOGY EDUCATION PROGRAM What Financial Conditions Must Be Met by a State? § 403.186 What are... 34 Education 3 2011-07-01 2011-07-01 false What are the administrative cost requirements applicable to a State? 403.186 Section 403.186 Education Regulations of the Offices of the Department...

  12. 34 CFR 403.195 - What are the administrative cost requirements applicable to local recipients?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... VOCATIONAL AND APPLIED TECHNOLOGY EDUCATION PROGRAM What Conditions Must be Met by Local Recipients? § 403... 34 Education 3 2013-07-01 2013-07-01 false What are the administrative cost requirements applicable to local recipients? 403.195 Section 403.195 Education Regulations of the Offices of...

  13. 34 CFR 403.195 - What are the administrative cost requirements applicable to local recipients?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... VOCATIONAL AND APPLIED TECHNOLOGY EDUCATION PROGRAM What Conditions Must be Met by Local Recipients? § 403... 34 Education 3 2014-07-01 2014-07-01 false What are the administrative cost requirements applicable to local recipients? 403.195 Section 403.195 Education Regulations of the Offices of...

  14. 34 CFR 403.186 - What are the administrative cost requirements applicable to a State?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... APPLIED TECHNOLOGY EDUCATION PROGRAM What Financial Conditions Must Be Met by a State? § 403.186 What are... 34 Education 3 2012-07-01 2012-07-01 false What are the administrative cost requirements applicable to a State? 403.186 Section 403.186 Education Regulations of the Offices of the Department...

  15. 34 CFR 403.186 - What are the administrative cost requirements applicable to a State?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... APPLIED TECHNOLOGY EDUCATION PROGRAM What Financial Conditions Must Be Met by a State? § 403.186 What are... 34 Education 3 2014-07-01 2014-07-01 false What are the administrative cost requirements applicable to a State? 403.186 Section 403.186 Education Regulations of the Offices of the Department...

  16. 34 CFR 403.195 - What are the administrative cost requirements applicable to local recipients?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... VOCATIONAL AND APPLIED TECHNOLOGY EDUCATION PROGRAM What Conditions Must be Met by Local Recipients? § 403... 34 Education 3 2011-07-01 2011-07-01 false What are the administrative cost requirements applicable to local recipients? 403.195 Section 403.195 Education Regulations of the Offices of...

  17. 34 CFR 403.186 - What are the administrative cost requirements applicable to a State?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... APPLIED TECHNOLOGY EDUCATION PROGRAM What Financial Conditions Must Be Met by a State? § 403.186 What are... 34 Education 3 2013-07-01 2013-07-01 false What are the administrative cost requirements applicable to a State? 403.186 Section 403.186 Education Regulations of the Offices of the Department...

  18. 34 CFR 403.195 - What are the administrative cost requirements applicable to local recipients?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... VOCATIONAL AND APPLIED TECHNOLOGY EDUCATION PROGRAM What Conditions Must be Met by Local Recipients? § 403... 34 Education 3 2012-07-01 2012-07-01 false What are the administrative cost requirements applicable to local recipients? 403.195 Section 403.195 Education Regulations of the Offices of...

  19. 24 CFR 1000.26 - What are the administrative requirements under NAHASDA?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... sections of 24 CFR part 85 “Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments.” For purposes of this part, “grantee” as defined in 24 CFR part 85 has the... circumstances, acceptable methods to provide performance and payment assurance may include: (i) Deposit with...

  20. 34 CFR 403.195 - What are the administrative cost requirements applicable to local recipients?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... VOCATIONAL AND APPLIED TECHNOLOGY EDUCATION PROGRAM What Conditions Must be Met by Local Recipients? § 403... 34 Education 3 2010-07-01 2010-07-01 false What are the administrative cost requirements applicable to local recipients? 403.195 Section 403.195 Education Regulations of the Offices of...

  1. 34 CFR 403.186 - What are the administrative cost requirements applicable to a State?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... APPLIED TECHNOLOGY EDUCATION PROGRAM What Financial Conditions Must Be Met by a State? § 403.186 What are... 34 Education 3 2010-07-01 2010-07-01 false What are the administrative cost requirements applicable to a State? 403.186 Section 403.186 Education Regulations of the Offices of the Department...

  2. 24 CFR 511.72 - Applicability of uniform Federal administrative requirements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT SLUM CLEARANCE AND URBAN RENEWAL RENTAL REHABILITATON GRANT... Governments” (implemented at 24 CFR part 44), and with 24 CFR part 85, “Uniform Administrative Requirements... 24 Housing and Urban Development 3 2011-04-01 2010-04-01 true Applicability of uniform...

  3. 24 CFR 511.72 - Applicability of uniform Federal administrative requirements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT SLUM CLEARANCE AND URBAN RENEWAL RENTAL REHABILITATION GRANT... Governments” (implemented at 24 CFR part 44), and with 24 CFR part 85, “Uniform Administrative Requirements... 24 Housing and Urban Development 3 2013-04-01 2013-04-01 false Applicability of uniform...

  4. 24 CFR 511.72 - Applicability of uniform Federal administrative requirements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT SLUM CLEARANCE AND URBAN RENEWAL RENTAL REHABILITATION GRANT... Governments” (implemented at 24 CFR part 44), and with 24 CFR part 85, “Uniform Administrative Requirements... 24 Housing and Urban Development 3 2012-04-01 2012-04-01 false Applicability of uniform...

  5. 24 CFR 511.72 - Applicability of uniform Federal administrative requirements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT SLUM CLEARANCE AND URBAN RENEWAL RENTAL REHABILITATON GRANT... Governments” (implemented at 24 CFR part 44), and with 24 CFR part 85, “Uniform Administrative Requirements... 24 Housing and Urban Development 3 2010-04-01 2010-04-01 false Applicability of uniform...

  6. 24 CFR 511.72 - Applicability of uniform Federal administrative requirements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT SLUM CLEARANCE AND URBAN RENEWAL RENTAL REHABILITATION GRANT... Governments” (implemented at 24 CFR part 44), and with 24 CFR part 85, “Uniform Administrative Requirements... 24 Housing and Urban Development 3 2014-04-01 2013-04-01 true Applicability of uniform...

  7. 26 CFR 1.468B-2 - Taxation of qualified settlement funds and related administrative requirements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 26 Internal Revenue 6 2010-04-01 2010-04-01 false Taxation of qualified settlement funds and... Taken § 1.468B-2 Taxation of qualified settlement funds and related administrative requirements. (a) In...) of this section is in lieu of any other taxation of the income of a qualified settlement fund...

  8. 75 FR 18219 - Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

    ... HUMAN SERVICES Food and Drug Administration Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and Supplier Controls; Public Educational Forum AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public educational forum. SUMMARY: The Food and Drug Administration...

  9. FDA's Laser Notice 50: a step toward global harmonization

    NASA Astrophysics Data System (ADS)

    Kent, Suzie L. B.; Dennis, Jerome E.; Zaharek, Gary L.; Eng, Francis J.

    2003-06-01

    The US Food and Drug Administration, Center of Devices and Radiological Health issued Laser Notice 50 in July 2001. This Notice is a preliminary step that FDA has taken to harmonize US regulations for laser products (21 Code of Federal Regulations) with the IEC (International Electrotechnical Commission) standards for Safety of Laser Products. The paper discusses rationale for the changes and describes some of the implementation issues, including comparisons between the current standards. The impact on the regulated industry and the user community is that the same laser hazard classification scheme is used and that engineered safety features are consistentin the world markets.

  10. The new label for erythropoiesis stimulating agents: the FDA'S sentence.

    PubMed

    Fishbane, Steven; Jhaveri, Kenar D

    2012-05-01

    On June 24, 2011, the U.S. Food and Drug Administration (FDA) revised the prescribing instructions (the label) for erythropoiesis-stimulating agents. The new label, the second revision since publication of the TREAT Study, placed new restrictions on the use of these agents, and increased the strength of warnings. We believe that the new label language may deprive patients of the full benefits of erythropoiesis-stimulating agent treatment and impair the opportunity to individualize treatment through shared decision making. Diminished discovery and innovation in the treatment of one of the most common and important complications of kidney disease may also be an unintended consequence of the label change. PMID:22515844

  11. 2015 in review: FDA approval of new drugs.

    PubMed

    Kinch, Michael S

    2016-07-01

    The myriad new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in 2015 reflected both the opportunities and risks associated with the development of new medicines. On the one hand, the approval of 45 NMEs was among the highest ever recorded. Likewise, the diversity underlying the mechanistic basis of new medicines suggests continued broadening relative to the predominate trends of the past few decades. On the other hand, closer inspection indicates that business model decisions surrounding orphan indications and consolidation could be placing the industry in an ever-more precarious position, with severe implications for the sustainability of the entire enterprise. PMID:27109618

  12. Did FDA Decisionmaking Affect Anti-Psychotic Drug Prescribing in Children?: A Time-Trend Analysis

    PubMed Central

    Wang, Bo; Franklin, Jessica M.; Eddings, Wesley; Landon, Joan; Kesselheim, Aaron S.

    2016-01-01

    Background Following Food and Drug Administration (FDA) approval, many drugs are prescribed for non-FDA-approved (“off-label”) uses. If substantial evidence supports the efficacy and safety of off-label indications, manufacturers can pursue formal FDA approval through supplemental new drug applications (sNDAs). We evaluated the effect of FDA determinations on pediatric sNDAs for antipsychotic drugs on prescribing of these products in children. Methods Retrospective, segmented time-series analysis using new prescription claims during 2003–2012 for three atypical antipsychotics (olanzapine, quetiapine, ziprasidone). FDA approved the sNDAs for pediatric use of olanzapine and quetiapine in December 2009, but did not approve the sNDA for pediatric use of ziprasidone. Results During the months before FDA approval of its pediatric sNDA, new prescriptions of olanzapine decreased for both children and adults. After FDA approval, the increase in prescribing trends was similar for both age groups (P = 0.47 for schizophrenia and bipolar disorder; P = 0.37 for other indications). Comparable decreases in use of quetiapine were observed between pediatrics and adults following FDA approval of its pediatric sNDA (P = 0.88; P = 0.63). Prescribing of ziprasidone decreased similarly for pediatric and adult patients after FDA non-approval of its pediatric sNDA (P = 0.61; P = 0.79). Conclusions The FDA’s sNDA determinations relating to use of antipsychotics in children did not result in changes in use that favored the approved sNDAs and disfavored the unapproved sNDA. Improved communication may help translate the agency’s expert judgments to clinical practice. PMID:27032095

  13. 76 FR 38961 - Tobacco Products, Exemptions From Substantial Equivalence Requirements

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-05

    ... / Tuesday, July 5, 2011 / Rules and Regulations#0;#0; ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and... Substantial Equivalence Requirements AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is issuing this final rule to establish procedures...

  14. 32 CFR Appendix C to Part 22 - Administrative Requirements and Issues To Be Addressed in Award Terms and Conditions

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 32 National Defense 1 2013-07-01 2013-07-01 false Administrative Requirements and Issues To Be Addressed in Award Terms and Conditions C Appendix C to Part 22 National Defense Department of Defense... AND ADMINISTRATION Pt. 22, App. C Appendix C to Part 22—Administrative Requirements and Issues To...

  15. 32 CFR Appendix C to Part 22 - Administrative Requirements and Issues To Be Addressed in Award Terms and Conditions

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 1 2010-07-01 2010-07-01 false Administrative Requirements and Issues To Be Addressed in Award Terms and Conditions C Appendix C to Part 22 National Defense Department of Defense... AND ADMINISTRATION Pt. 22, App. C Appendix C to Part 22—Administrative Requirements and Issues To...

  16. 32 CFR Appendix C to Part 22 - Administrative Requirements and Issues To Be Addressed in Award Terms and Conditions

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 32 National Defense 1 2011-07-01 2011-07-01 false Administrative Requirements and Issues To Be Addressed in Award Terms and Conditions C Appendix C to Part 22 National Defense Department of Defense... AND ADMINISTRATION Pt. 22, App. C Appendix C to Part 22—Administrative Requirements and Issues To...

  17. Novel algorithms for improved pattern recognition using the US FDA Adverse Event Network Analyzer.

    PubMed

    Botsis, Taxiarchis; Scott, John; Goud, Ravi; Toman, Pamela; Sutherland, Andrea; Ball, Robert

    2014-01-01

    The medical review of adverse event reports for medical products requires the processing of "big data" stored in spontaneous reporting systems, such as the US Vaccine Adverse Event Reporting System (VAERS). VAERS data are not well suited to traditional statistical analyses so we developed the FDA Adverse Event Network Analyzer (AENA) and three novel network analysis approaches to extract information from these data. Our new approaches include a weighting scheme based on co-occurring triplets in reports, a visualization layout inspired by the islands algorithm, and a network growth methodology for the detection of outliers. We explored and verified these approaches by analysing the historical signal of Intussusception (IS) after the administration of RotaShield vaccine (RV) in 1999. We believe that our study supports the use of AENA for pattern recognition in medical product safety and other clinical data. PMID:25160375

  18. The FDA Perspective on Pre-Clinical Testing for High Intensity Focused Ultrasound Devices

    NASA Astrophysics Data System (ADS)

    Harris, Gerald R.

    2006-05-01

    In the U. S., the pre-market review of high intensity focused ultrasound (HIFU) devices is carried out under the authority of the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act. Different regulatory mechanisms may apply depending on the complexity of the HIFU device and the indications for use, but in all cases pre-clinical testing is required. This testing typically includes ultrasound field characterization, thermal modeling and measurement, and may include demonstrating the accuracy of targeting and monitoring, if applicable. Because there are no guidance documents or standards for these tests at present, the U.S. Food and Drug Administration (FDA) welcomes working with interested parties to develop acceptable procedures that can be incorporated into the regulatory review process.

  19. 20 CFR 671.170 - What are the program and administrative requirements that apply to national emergency grants?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...? (a) In general, the program requirements and administrative standards set forth at 20 CFR parts 663... costs based on the design and complexity of the project. We will negotiate administration costs with...

  20. 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

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Patient Network Annual Meeting..., Steve.Morin@fda.hhs.gov . SUPPLEMENTARY INFORMATION: I. FDA Patient Network This is the inaugural FDA Patient Network Annual Meeting hosted by the FDA Office of Special Health Issues, the Agency's liaison...

  1. No sisyphean task: how the FDA can regulate electronic cigarettes.

    PubMed

    Paradise, Jordan

    2013-01-01

    The adverse effects of smoking have fostered a natural market for smoking cessation and smoking reduction products. Smokers attempting to quit or reduce consumption have tried everything: "low" or "light" cigarettes; nicotine-infused chewing gum, lozenges, and lollipops; dermal patches; and even hypnosis. The latest craze in the quest to find a safer source of nicotine is the electronic cigarette. Electronic cigarettes (e-cigarettes) have swept the market, reaching a rapidly expanding international consumer base. Boasting nicotine delivery and the tactile feel of a traditional cigarette without the dozens of other chemical constituents that contribute to carcinogenicity, e-cigarettes are often portrayed as less risky, as a smoking reduction or even a complete smoking cessation product, and perhaps most troubling for its appeal to youth, as a flavorful, trendy, and convenient accessory. The sensationalism associated with e-cigarettes has spurred outcry from health and medical professional groups, as well as the Food and Drug Administration (FDA), because of the unknown effects on public health. Inhabiting a realm of products deemed "tobacco products" under recent 2009 legislation, e-cigarettes pose new challenges to FDA regulation because of their novel method of nicotine delivery, various mechanical and electrical parts, and nearly nonexistent safety data. Consumer use, marketing and promotional claims, and technological characteristics of e-cigarettes have also raised decades old questions of when the FDA can assert authority over products as drugs or medical devices. Recent case law restricting FDA enforcement efforts against e-cigarettes further confounds the distinction among drugs and medical devices, emerging e-cigarette products, and traditional tobacco products such as cigarettes, cigars, and smokeless tobacco. This Article investigates the e-cigarette phenomenon in the wake of the recently enacted Family Smoking Prevention and Tobacco Control Act of 2009

  2. FDA aprueba la primera inmunoterapia para linfoma

    Cancer.gov

    La FDA ha aprobado nivolumab (Opdivo®) para el tratamiento de pacientes con el linfoma clásico de Hodgkin que ha recaído o empeorado después de recibir un trasplante autólogo hematopoyético seguido de brentuximab vedotin (Adcetris®)

  3. 20 CFR 671.170 - What are the program and administrative requirements that apply to national emergency grants?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... WORKERS § 671.170 What are the program and administrative requirements that apply to national emergency grants? (a) In general, the program requirements and administrative standards set forth at 20 CFR parts... requirements that apply to national emergency grants? 671.170 Section 671.170 Employees' Benefits...

  4. 20 CFR 671.170 - What are the program and administrative requirements that apply to national emergency grants?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... WORKERS § 671.170 What are the program and administrative requirements that apply to national emergency grants? (a) In general, the program requirements and administrative standards set forth at 20 CFR parts... requirements that apply to national emergency grants? 671.170 Section 671.170 Employees' Benefits...

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

    PubMed Central

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

    2012-01-01

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

  6. Antidepressants and Suicide Risk: How Did Specific Information in FDA Safety Warnings Affect Treatment Patterns?

    PubMed Central

    Busch, Susan H.; Frank, Richard G.; Leslie, Doug; Martin, Andres; Martin, Erika; Rosenheck, Robert; Barry, Colleen L.

    2009-01-01

    Objective From June 2003 through October 2004, the Food and Drug Administration (FDA) released five safety warnings related to antidepressant use and increased suicide risk in children. While researchers have documented a decline in antidepressant use in children over this time period, less is known about whether specific safety information conveyed in individual warnings was reflected in treatment patterns. Methods Thomson Marketscan claims data (2001–2005) for a national sample of privately insured children were used to construct treatment episodes (N=23,529). For each new episode of major depressive disorder, it was determined whether children’s treatment followed specific recommendations included in warnings released by the FDA. Treatment recommendations pertained to the use of the antidepressants paroxetine and fluoxetine and to patient monitoring. Treatment patterns were expected to change as the nature of risk information conveyed by the FDA changed over time. Results The timing of FDA recommendations was associated with trends in the use of paroxetine and fluoxetine by children with major depressive disorder newly initiating antidepressant treatment. However, no evidence of increases in outpatient visits (i.e., monitoring) among depressed children initiating antidepressants was found. Conclusions Release of specific risk and benefit information by the FDA was associated with changes in prescribing, but not outpatient follow-up. These results suggest the FDA plays an important role in communicating information to the public and providers, but while public health safety warnings were associated with changes in some practice patterns, not all recommendations conveyed in warnings were followed. PMID:20044412

  7. Regulatory Requirements for Devices for the Handicapped.

    ERIC Educational Resources Information Center

    Stigi, John, Ed.; Rivera, Richard J., Ed.

    This booklet explains in question/answer form the basic regulatory requirements established by the Food and Drug Administration (FDA) of the federal government concerning the manufacture, marketing and distribution of medical devices (including implantable devices and devices previously regulated as drugs) for persons with disabilities. Topics…

  8. Health care administration in the year 2000: practitioners' views of future issues and job requirements.

    PubMed

    Hudak, R P; Brooke, P P; Finstuen, K; Riley, P

    1993-01-01

    This research identifies the most important domains in health care administration (HCA) from now to the year 2000 and differentiates job skill, knowledge, and ability requirements necessary for successful management. Fellows of the American College of Healthcare Executives from about half of the United States responded to two iterations of a Delphi mail inquiry. Fellows identified 102 issues that were content-analyzed into nine domains by an HCA expert panel. Domains, in order of ranked importance, were cost/finance, leadership, professional staff interactions, health care delivery concepts, accessibility, ethics, quality/risk management, technology, and marketing. In the second Delphi iteration, Fellows reviewed domain results and rated job requirements on required job importance. Results indicated that while a business orientation is needed for organizational survival, an equal emphasis on person-oriented skills, knowledge, and abilities is required. PMID:10126189

  9. Comparative Perceptions of Students, Financial Aid Administrators, and Presidents Regarding the Required Competencies of Community College Financial Aid Administrators.

    ERIC Educational Resources Information Center

    Herndon, Charles Frederick

    As a basis for the establishment of meaningful training programs for community college financial aid administrators, presidents, financial aid administrators, and student aid recipients at 45 California community colleges were surveyed in regard to the attributes and competencies deemed essential for this position. The survey instrument contained…

  10. Electrosurgical injuries during robot assisted surgery: insights from the FDA MAUDE database

    NASA Astrophysics Data System (ADS)

    Fuller, Andrew; Vilos, George A.; Pautler, Stephen E.

    2012-02-01

    Introduction: The da Vinci surgical system requires the use of electrosurgical instruments. The re-use of such instruments creates the potential for stray electrical currents from capacitive coupling and/or insulation failure with subsequent injury. The morbidity of such injuries may negate many of the benefits of minimally invasive surgery. We sought to evaluate the rate and nature of electrosurgical injury (ESI) associated with this device. Methods: The Manufacturer and User Facility Device Experience (MAUDE) database is administered by the US Food and Drug Administration (FDA) and reports adverse events related to medical devices in the United States. We analyzed all incidents in the context of robotic surgery between January 2001 and June 2011 to identify those related to the use of electrosurgery. Results: In the past decade, a total of 605 reports have been submitted to the FDA with regard to adverse events related to the da Vinci robotic surgical platform. Of these, 24 (3.9%) were related to potential or actual ESI. Nine out of the 24 cases (37.5%) resulted in additional surgical intervention for repair. There were 6 bowel injuries of which only one was recognized and managed intra-operatively. The remainder required laparotomy between 5 and 8 days after the initial robotic procedure. Additionally, there were 3 skin burns. The remaining cases required conservative management or resulted in no harm. Conclusion: ESI in the context of robotic surgery is uncommon but remains under-recognized and under-reported. Surgeons performing robot assisted surgery should be aware that ESI can occur with robotic instruments and vigilance for intra- and post-operative complications is paramount.

  11. Mining FDA drug labels for medical conditions

    PubMed Central

    2013-01-01

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

  12. 10 CFR 35.396 - Training for the parenteral administration of unsealed byproduct material requiring a written...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Training for the parenteral administration of unsealed byproduct material requiring a written directive. 35.396 Section 35.396 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Unsealed Byproduct Material-Written Directive Required § 35.396 Training for the parenteral administration...

  13. 10 CFR 35.396 - Training for the parenteral administration of unsealed byproduct material requiring a written...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Training for the parenteral administration of unsealed byproduct material requiring a written directive. 35.396 Section 35.396 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Unsealed Byproduct Material-Written Directive Required § 35.396 Training for the parenteral administration...

  14. 10 CFR 35.396 - Training for the parenteral administration of unsealed byproduct material requiring a written...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Training for the parenteral administration of unsealed byproduct material requiring a written directive. 35.396 Section 35.396 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Unsealed Byproduct Material-Written Directive Required § 35.396 Training for the parenteral administration...

  15. 10 CFR 35.396 - Training for the parenteral administration of unsealed byproduct material requiring a written...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Training for the parenteral administration of unsealed byproduct material requiring a written directive. 35.396 Section 35.396 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Unsealed Byproduct Material-Written Directive Required § 35.396 Training for the parenteral administration...

  16. 10 CFR 35.396 - Training for the parenteral administration of unsealed byproduct material requiring a written...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Training for the parenteral administration of unsealed byproduct material requiring a written directive. 35.396 Section 35.396 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Unsealed Byproduct Material-Written Directive Required § 35.396 Training for the parenteral administration...

  17. 76 FR 1180 - FDA Transparency Initiative: Improving Transparency to Regulated Industry

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ... response to a request for input from FDA on this topic in March 2010 (75 FR 11893, March 12, 2010... Policy, Planning, and Budget, Food and Drug Administration, 10903 New Hampshire Ave., Bldg 32, rm. 4226...'' and directing the Director of the Office of Management and Budget (OMB) to issue an Open...

  18. 21 CFR 803.3 - How does FDA define the terms used in this part?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false How does FDA define the terms used in this part? 803.3 Section 803.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., as amended. Ambulatory surgical facility...

  19. 21 CFR Appendix B to Part 101 - Graphic Enhancements Used by the FDA

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Graphic Enhancements Used by the FDA B Appendix B to Part 101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Pt. 101, App. B Appendix B to Part...

  20. FDA Bioinformatics Tool for Microbial Genomics Research on Molecular Characterization of Bacterial Foodborne Pathogens Using Microarrays

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Background: Advances in microbial genomics and bioinformatics are offering greater insights into the emergence and spread of foodborne pathogens in outbreak scenarios. The Food and Drug Administration (FDA) has developed the genomics tool ArrayTrackTM, which provides extensive functionalities to man...

  1. 21 CFR Appendix B to Part 101 - Graphic Enhancements Used by the FDA

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Graphic Enhancements Used by the FDA B Appendix B to Part 101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Pt. 101, App. B Appendix B to Part...

  2. 76 FR 30175 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-24

    ... the document at http://www.regulations.gov or http://www.fda.gov/ScienceResearch/SpecialTopics/Running... Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New... Office of Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation and...

  3. FDA Recommends All Blood Donations Be Tested for Zika

    MedlinePlus

    ... FDA Recommends All Blood Donations Be Tested for Zika Updated guidance provides further protection for U.S. blood ... entire blood supply be routinely screened for the Zika virus. In February, the FDA recommended testing of ...

  4. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  5. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  6. Nanotechnology Laboratory Continues Partnership with FDA and National Institute of Standards and Technology | Poster

    Cancer.gov

    The NCI-funded Nanotechnology Characterization Laboratory (NCL)—a leader in evaluating promising nanomedicines to fight cancer—recently renewed its collaboration with the U.S. Food and Drug Administration (FDA) and the National Institute of Standards and Technology (NIST) to continue its groundbreaking work on characterizing nanomedicines and moving them toward the clinic. In partnership with NIST and the FDA, NCL has laid a solid, scientific foundation for using the power of nanotechnology to increase the potency and target the delivery

  7. 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

    ... In the February 15, 2005, issue of the Federal Register (70 FR 7747), FDA issued a notice announcing... disclosure. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR...

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

    PubMed

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

    2012-01-01

    Public agencies have discretion on the time domain, and politicians deploy numerous policy instruments to constrain it. Yet little is known about how administrative procedures that affect timing also affect the quality of agency decisions. We examine whether administrative deadlines shape decision timing and the observed quality of decisions. Using a unique and rich dataset of FDA drug approvals that allows us to examine decision timing and quality, we find that this administrative tool induces a piling of decisions before deadlines, and that these “just-before-deadline” approvals are linked with higher rates of postmarket safety problems (market withdrawals, severe safety warnings, safety alerts). Examination of data from FDA advisory committees suggests that the deadlines may impede quality by impairing late-stage deliberation and agency risk communication. Our results both support and challenge reigning theories about administrative procedures, suggesting they embody expected control-expertise trade-offs, but may also create unanticipated constituency losses. PMID:22400144

  9. 76 FR 52669 - Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-23

    ...The Food and Drug Administration (FDA) is correcting a notice of availability that appeared in the Federal Register of August 4, 2011 (76 FR 47211). The Agency is required to report annually in the Federal Register on the status of postmarketing requirements and commitments required of, or agreed upon by, holders of approved drug and biological products. The August 4, 2011, notice is the......

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

    PubMed

    Kesselheim, A S; Darrow, J J

    2015-01-01

    New prescription drugs receive approval from the US Food and Drug Administration (FDA) based on tests establishing safety and adequate and well-controlled trials demonstrating "substantial evidence" of efficacy. However, a number of legislative and regulatory initiatives, the most recent being the breakthrough therapy designation created in 2012, give the FDA flexibility to approve drugs on the basis of less rigorous data in situations of greater clinical need. These expedited development and review pathways now contribute to a majority of all new drug approvals and have important benefits in encouraging efficient availability of transformative drugs. They also have a number of risks, including a heightened possibility that the drugs will be discovered to be ineffective or unsafe after widespread use, and confusion by patients and physicians over what it means for a product to be "FDA approved." PMID:25670381

  11. Summaries of Safety Labeling Changes Approved by the FDA: Boxed Warnings Highlights.

    PubMed

    Rose, Brenda

    2016-06-01

    As part of the US Food and Drug Administration's MedWatch program, safety labeling changes are reviewed and compiled monthly for drugs and therapeutic biologics where important changes have been made to the safety information. Boxed warnings (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075096.pdf) are ordinarily used to highlight either adverse reactions so serious in proportion to the potential benefit from the drug that it is essential that it be considered in assessing the risks and benefits of using the drugs or serious adverse reactions that can be prevented/reduced in frequency or severity by appropriate use of the drug; or FDA approved the drug with restrictions to ensure safe use because FDA concluded that the drug can be safely used only if distribution or use is restricted. There were 4 revised boxed warning from January through March 2016. PMID:27354752

  12. Large Eddy Simulation of FDA's Idealized Medical Device.

    PubMed

    Delorme, Yann T; Anupindi, Kameswararao; Frankel, Steven H

    2013-12-01

    A hybrid large eddy simulation (LES) and immersed boundary method (IBM) computational approach is used to make quantitative predictions of flow field statistics within the Food and Drug Administration's (FDA) idealized medical device. An in-house code is used, hereafter (W enoHemo(™) ), that combines high-order finite-difference schemes on structured staggered Cartesian grids with an IBM to facilitate flow over or through complex stationary or rotating geometries and employs a subgrid-scale (SGS) turbulence model that more naturally handles transitional flows [2]. Predictions of velocity and wall shear stress statistics are compared with previously published experimental measurements from Hariharan et al. [6] for the four Reynolds numbers considered. PMID:24187599

  13. 77 FR 41416 - Food and Drug Administration/Xavier University Global Outsourcing Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-13

    ...The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University Global Outsourcing Conference.'' This public conference for the pharmaceutical industry is in direct alignment with the ``FDA Strategic Priorities 2011-2015,'' and includes presentations from key FDA officials, global......

  14. 76 FR 56770 - Food and Drug Administration/Xavier University Global Outsourcing Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-14

    ...The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University Global Outsourcing Conference.'' This 2.5-day public conference for the pharmaceutical industry is in direct alignment with the ``FDA Strategic Priorities 2011-2015,'' and includes presentations from key FDA officials, global......

  15. Current good manufacturing practices, quality control procedures, quality factors, notification requirements, and records and reports, for infant formula. Final rule.

    PubMed

    2014-06-10

    The Food and Drug Administration (FDA or we) is issuing a final rule that adopts, with some modifications, the interim final rule (IFR) entitled "Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula'' (February 10, 2014). This final rule affirms the IFR's changes to FDA's regulations and provides additional modifications and clarifications. The final rule also responds to certain comments submitted in response to the request for comments in the IFR. PMID:24922980

  16. 77 FR 55845 - Science Board to the Food and Drug Administration: Request for Nominations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-11

    ... HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration: Request... Administration (FDA) is requesting nominations to serve on the Science Board to FDA (Science Board). FDA seeks to... given first consideration for membership on the Science Board. Nominations received after October...

  17. FDA Approval Summary: Ramucirumab for Gastric Cancer.

    PubMed

    Casak, Sandra J; Fashoyin-Aje, Ibilola; Lemery, Steven J; Zhang, Lillian; Jin, Runyan; Li, Hongshan; Zhao, Liang; Zhao, Hong; Zhang, Hui; Chen, Huanyu; He, Kun; Dougherty, Michele; Novak, Rachel; Kennett, Sarah; Khasar, Sachia; Helms, Whitney; Keegan, Patricia; Pazdur, Richard

    2015-08-01

    The FDA approved ramucirumab (CYRAMZA; Eli Lilly and Company) for previously treated patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma initially as monotherapy (April 21, 2014) and subsequently as combination therapy with paclitaxel (November 5, 2014). In the monotherapy trial, 355 patients in the indicated population were randomly allocated (2:1) to receive ramucirumab or placebo, 8 mg/kg intravenously every 2 weeks. In the combination trial, 665 patients were randomly allocated (1:1) to receive ramucirumab or placebo, 8 mg/kg intravenously every 2 weeks, in combination with paclitaxel, 80 mg/m(2) on days 1, 8, and 15 of 28-day cycles. Overall survival (OS) was increased in patients who received ramucirumab in both the monotherapy [HR, 0.78; 95% confidence interval (CI), 0.60-0.998; log rank P = 0.047] and combination trials (HR, 0.81; 95% CI, 0.68-0.96; P = 0.017). The most common adverse reactions were hypertension and diarrhea in the monotherapy trial and fatigue, neutropenia, diarrhea, and epistaxis in the combination trial. Because of concerns about the robustness of the monotherapy trial results, FDA approved the original application after receiving the results of the combination trial confirming the OS effect. Based on exploratory exposure-response analyses, there is residual uncertainty regarding the optimal dose of ramucirumab. PMID:26048277

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

    PubMed

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

    2013-09-01

    We compared and determined the reasons for any differences in the review and approval times of tyrosine kinase inhibitors (TKIs) by the US Food and Drug Administration (FDA) and the European EMA/CHMP. Applications for these novel cancer drugs were submitted to them within a mean of 31.2 days of each other, providing a fair basis for comparison. The FDA had granted priority review to 12 TKIs but the EMA/CHMP did not grant the equivalent accelerated assessment to any. The FDA granted accelerated approvals to six (38%) and CHMP granted (the equivalent) conditional approvals to four (29%) of these agents. On average, the review and approval times were 205.3 days in the US compared with 409.6 days in the European Union (EU). The active review times, however, were comparable (225.4 days in the EU and 205.3 days in the US). Since oncology drug development lasts about 7 years, the 20 days difference in review times between the two agencies is inconsequential. Clock stops during review and the time required to issue an approval had added the extra 184.2 days to review time in the EU. We suggest possible solutions to expedite the EU review and approval processes. However, post-marketing emergence of adverse efficacy and safety data on gefitinib and lapatinib, respectively, indicate potential risks of expedited approvals. We challenge the widely prevalent myth that early approval translates into early access or beneficial impact on public health. Both the agencies collaborate closely but conduct independent assessments and make decisions based on distinct legislation, procedures, precedents and societal expectations. PMID:23362829

  19. 20 CFR 671.170 - What are the program and administrative requirements that apply to national emergency grants?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 20 Employees' Benefits 3 2011-04-01 2011-04-01 false What are the program and administrative requirements that apply to national emergency grants? 671.170 Section 671.170 Employees' Benefits EMPLOYMENT AND TRAINING ADMINISTRATION, DEPARTMENT OF LABOR NATIONAL EMERGENCY GRANTS FOR DISLOCATED WORKERS § 671.170 What are the program...

  20. 78 FR 57320 - Food and Drug Administration Food Safety Modernization Act: Proposed Rules on Foreign Supplier...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-18

    ...The Food and Drug Administration (FDA or we) is announcing two public meetings to discuss two proposed rules aimed at strengthening assurances that imported food meets the same safety standards as food produced domestically. The Foreign Supplier Verification Programs (FSVP) proposal establishes requirements for importers to verify that their foreign suppliers are implementing the modern,......

  1. 78 FR 11654 - Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-19

    ... Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act.'' FDA is... information required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance is...

  2. 21 CFR 314.650 - Termination of requirements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Termination of requirements. 314.650 Section 314.650 Food 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 Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible...

  3. 21 CFR 314.560 - Termination of requirements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Termination of requirements. 314.560 Section 314.560 Food 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 Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses...

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

    PubMed Central

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

    2016-01-01

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

  5. 29 CFR 2590.606-4 - Notice requirements for plan administrators.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... the Social Security Administration, under title II or XVI of the Social Security Act (42 U.S.C. 401 et... disability by the Social Security Administration regarding a covered employee, qualified beneficiary,...

  6. 29 CFR 2590.606-4 - Notice requirements for plan administrators.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... the Social Security Administration, under title II or XVI of the Social Security Act (42 U.S.C. 401 et... disability by the Social Security Administration regarding a covered employee, qualified beneficiary,...

  7. 29 CFR 2590.606-4 - Notice requirements for plan administrators.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... the Social Security Administration, under title II or XVI of the Social Security Act (42 U.S.C. 401 et... disability by the Social Security Administration regarding a covered employee, qualified beneficiary,...

  8. 29 CFR 2590.606-4 - Notice requirements for plan administrators.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... the Social Security Administration, under title II or XVI of the Social Security Act (42 U.S.C. 401 et... disability by the Social Security Administration regarding a covered employee, qualified beneficiary,...

  9. Target selection for FDA-approved medicines.

    PubMed

    Kinch, Michael S; Hoyer, Denton; Patridge, Eric; Plummer, Mark

    2015-07-01

    The biopharmaceutical industry translates fundamental understanding of disease into new medicines. As part of a comprehensive analysis of FDA-approved new molecular entities (NMEs), we assessed the mechanistic basis of drug efficacy, with emphasis on target selection. Three target families capture almost half of all NMEs and the leading ten families capture more than three-quarters of NME approvals. Target families were related to their clinical application and identify dynamic trends in targeting over time. These data suggest increasing attention toward novel target families, which presumably reflects increased understanding of disease etiology. We also suggest the need to balance the ongoing emphasis on target-based drug discovery with phenotypic approaches to drug discovery. PMID:25462532

  10. Disparities in Discontinuing Rosiglitazone Following the 2007 FDA Safety Alert

    PubMed Central

    Qato, Danya M.; Trivedi, Amal N.; Mor, Vincent; Dore, David D.

    2016-01-01

    Background Responsiveness to the Food and Drug Administration (FDA) rosiglitazone safety alert, issued on May 21, 2007, has not been examined among vulnerable subpopulations of the elderly. Objective To compare time to discontinuation of rosiglitazone after the safety alert between black and white elderly persons, and across sociodemographic and economic subgroups. Research Design A cohort study. Subjects Medicare fee-for-service enrollees in 2007 who were established users of rosiglitazone identified from a 20% national sample of pharmacy claims. Measures Outcome of interest was time to discontinuation of rosiglitazone after the May alert. We modeled the number of days following the warning to the end of the days’ supply for the last rosiglitazone claim during the study period (May 21, 2007–December 31, 2007) using multivariable proportional hazards models. Results More than 67% of enrollees discontinued rosiglitazone within six months of the advisory. In adjusted analysis, white enrollees (hazard ratio = 0.90; 95% confidence interval, 0.86–0.94) discontinued rosiglitazone later than the comparison group of black enrollees. Enrollees with a history of low personal income also discontinued later than their comparison group (hazard ratio = 0.84; 95% confidence interval, 0.81–0.87). There were no observed differences across quintiles of area-level socioeconomic status. Conclusions White race and a history of low personal income modestly predicted later discontinuation of rosiglitazone after the FDA’s safety advisory in 2007. The impact of FDA advisories can vary among sociodemographic groups. Policymakers should continue to monitor whether risk management policies reach their intended populations. PMID:26978569

  11. The FDA's new advice on fish: it's complicated.

    PubMed

    Wenstrom, Katharine D

    2014-11-01

    The Food and Drug Administration and Environmental Protection Agency recently issued an updated draft of advice on fish consumption for pregnant and breastfeeding women, after survey data indicated that the majority of pregnant women do not eat much fish and thus may have inadequate intake of the omega 3 fatty acids eicosapentaenoic acid [EPA] and ducosahexaenoic acid [DHA]. Omega 3 fatty acids are essential components of membranes in all cells of the body and are vitally important for normal development of the brain and retinal tissues (especially myelin and retinal photoreceptors) and for maintenance of normal neurotransmission and connectivity. They also serve as substrates for the synthesis of a variety of antiinflammatory and inflammation-resolving mediators, favorably alter the production of thromboxane and prostaglandin E2, and improve cardiovascular health by preventing fatal arrhythmias and reducing triglyceride and C-reactive protein levels. Maternal ingestion of adequate quantities of fish (defined in many studies as at least 340 g of oily fish each week) has been associated with better childhood IQ scores, fine motor coordination, and communication and social skills, along with other benefits. Although the FDA did not clarify which fish to eat, it specifically advised against eating fish with the highest mercury levels and implied that fish with high levels of EPA and DHA and low levels of mercury are ideal. The FDA draft did not recommend taking omega 3 fatty acid or fish oil supplements instead of eating fish, which is advice that may reflect the fact that randomized controlled trials of DHA and EPA or fish oil supplementation generally have been disappointing and that the ideal daily dose of DHA and EPA is unknown. It seems safe to conclude that pregnant and nursing women should be advised to eat fish to benefit from naturally occurring omega 3 fatty acids, to avoid fish with high levels of mercury and other contaminants, and, if possible, to choose

  12. Monitoring Antimicrobial Resistance in the Food Supply Chain and Its Implications for FDA Policy Initiatives.

    PubMed

    Zawack, Kelson; Li, Min; Booth, James G; Love, Will; Lanzas, Cristina; Gröhn, Yrjö T

    2016-09-01

    In response to concerning increases in antimicrobial resistance (AMR), the Food and Drug Administration (FDA) has decided to increase veterinary oversight requirements for antimicrobials and restrict their use in growth promotion. Given the high stakes of this policy for the food supply, economy, and human and veterinary health, it is important to rigorously assess the effects of this policy. We have undertaken a detailed analysis of data provided by the National Antimicrobial Resistance Monitoring System (NARMS). We examined the trends in both AMR proportion and MIC between 2004 and 2012 at slaughter and retail stages. We investigated the makeup of variation in these data and estimated the sample and effect size requirements necessary to distinguish an effect of the policy change. Finally, we applied our approach to take a detailed look at the 2005 withdrawal of approval for the fluoroquinolone enrofloxacin in poultry water. Slaughter and retail showed similar trends. Both AMR proportion and MIC were valuable in assessing AMR, capturing different information. Most variation was within years, not between years, and accounting for geographic location explained little additional variation. At current rates of data collection, a 1-fold change in MIC should be detectable in 5 years and a 6% decrease in percent resistance could be detected in 6 years following establishment of a new resistance rate. Analysis of the enrofloxacin policy change showed the complexities of the AMR policy with no statistically significant change in resistance of both Campylobacter jejuni and Campylobacter coli to ciprofloxacin, another second-generation fluoroquinolone. PMID:27324772

  13. [Introduction of U.S. FDA mini-sentinel program].

    PubMed

    Xie, Yan-Ming; Liao, Xing; Shen, Hao

    2013-03-01

    In China, all of traditional Chinese medicine injections should pass clinical trials I, II and III for their safety and effectiveness before coming into the market. However, these clinical tests are mostly restricted to standard treatment for specific groups, and conducted in strict accordance with clinical trial protocols. In the real world, as there are more changes in the post-market clinical application of traditional Chinese medicine injections than in the experiment environment, regulatory bodies set stricter requirements for the post-market re-assessment on traditional Chinese medicine injections. Early-stage studies could only provide the most fundamental and restricted data of efficacy and safety of traditional Chinese medicine injections. In this essay, mini-sentinel program of U. S. FDA is introduced in order to provide reference for large-sample-size post-market clinical safety monitoring studies for traditional Chinese medicine injections. PMID:23724692

  14. Requirements for Certification of Teachers, Counselors, Librarians, Administrators for Elementary and Secondary Schools. Sixtieth Edition, 1995-96.

    ERIC Educational Resources Information Center

    Tryneski, John, Ed.

    This volume updates certification requirements and other pertinent information for K-12 teachers, administrators, librarians, counselors, and other school personnel. The publication lists: certification requirements for each state in the United States and the District of Columbia; recommendations of regional and national associations (Middle…

  15. 10 CFR 35.394 - Training for the oral administration of sodium iodide I-131 requiring a written directive in...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries). 35.394 Section 35.394 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Unsealed Byproduct Material-Written Directive Required...

  16. 10 CFR 35.394 - Training for the oral administration of sodium iodide I-131 requiring a written directive in...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries). 35.394 Section 35.394 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Unsealed Byproduct Material-Written Directive Required...

  17. 10 CFR 35.394 - Training for the oral administration of sodium iodide I-131 requiring a written directive in...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries). 35.394 Section 35.394 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Unsealed Byproduct Material-Written Directive Required...

  18. 10 CFR 35.394 - Training for the oral administration of sodium iodide I-131 requiring a written directive in...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries). 35.394 Section 35.394 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Unsealed Byproduct Material-Written Directive Required...

  19. 10 CFR 35.394 - Training for the oral administration of sodium iodide I-131 requiring a written directive in...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries). 35.394 Section 35.394 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Unsealed Byproduct Material-Written Directive Required...

  20. 26 CFR 1.414(r)-5 - Qualified separate line of business-administrative scrutiny requirement-safe harbors.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... the required period as provided under 17 CFR 240.12b-25(b)(2)(ii). Therefore, the required period for... 26 Internal Revenue 5 2010-04-01 2010-04-01 false Qualified separate line of business...-Sharing, Stock Bonus Plans, Etc. § 1.414(r)-5 Qualified separate line of business—administrative...

  1. 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

    ... examine and update current good manufacturing practice requirements and to develop an animal feed safety... methods in manufacturing, processing, packing, and holding food and feed. FDA is interested in making... three of the following five break-out sessions: Preventive Controls Guidance, On- Farm Manufacturing...

  2. FDA-Approved Natural Polymers for Fast Dissolving Tablets.

    PubMed

    Alam, Md Tausif; Parvez, Nayyar; Sharma, Pramod Kumar

    2014-01-01

    Oral route is the most preferred route for administration of different drugs because it is regarded as safest, most convenient, and economical route. Fast disintegrating tablets are very popular nowadays as they get dissolved or facilely disintegrated in mouth within few seconds of administration without the need of water. The disadvantages of conventional dosage form, especially dysphagia (arduousness in swallowing), in pediatric and geriatric patients have been overcome by fast dissolving tablets. Natural materials have advantages over synthetic ones since they are chemically inert, non-toxic, less expensive, biodegradable and widely available. Natural polymers like locust bean gum, banana powder, mango peel pectin, Mangifera indica gum, and Hibiscus rosa-sinenses mucilage ameliorate the properties of tablet and utilized as binder, diluent, and superdisintegrants increase the solubility of poorly water soluble drug, decrease the disintegration time, and provide nutritional supplement. Natural polymers are obtained from the natural origin and they are cost efficacious, nontoxic, biodegradable, eco-friendly, devoid of any side effect, renewable, and provide nutritional supplement. It is proved from the studies that natural polymers are more safe and efficacious than the synthetic polymers. The aim of the present article is to study the FDA-approved natural polymers utilized in fast dissolving tablets. PMID:26556207

  3. FDA-Approved Natural Polymers for Fast Dissolving Tablets

    PubMed Central

    Alam, Md Tausif; Parvez, Nayyar; Sharma, Pramod Kumar

    2014-01-01

    Oral route is the most preferred route for administration of different drugs because it is regarded as safest, most convenient, and economical route. Fast disintegrating tablets are very popular nowadays as they get dissolved or facilely disintegrated in mouth within few seconds of administration without the need of water. The disadvantages of conventional dosage form, especially dysphagia (arduousness in swallowing), in pediatric and geriatric patients have been overcome by fast dissolving tablets. Natural materials have advantages over synthetic ones since they are chemically inert, non-toxic, less expensive, biodegradable and widely available. Natural polymers like locust bean gum, banana powder, mango peel pectin, Mangifera indica gum, and Hibiscus rosa-sinenses mucilage ameliorate the properties of tablet and utilized as binder, diluent, and superdisintegrants increase the solubility of poorly water soluble drug, decrease the disintegration time, and provide nutritional supplement. Natural polymers are obtained from the natural origin and they are cost efficacious, nontoxic, biodegradable, eco-friendly, devoid of any side effect, renewable, and provide nutritional supplement. It is proved from the studies that natural polymers are more safe and efficacious than the synthetic polymers. The aim of the present article is to study the FDA-approved natural polymers utilized in fast dissolving tablets. PMID:26556207

  4. 78 FR 9703 - Food and Drug Administration/Xavier University PharmaLink Conference-Quality in a Global Supply...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-11

    ...The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University PharmaLink Conference.'' The PharmaLink conference seeks solutions to important and complicated issues by aligning with the strategic priorities of FDA, and includes presentations from key FDA officials, global regulators, and......

  5. Impact of FDA Actions, DTCA, and Public Information on the Market for Pain Medication.

    PubMed

    Bradford, W David; Kleit, Andrew N

    2015-07-01

    Nonsteroidal anti-inflammatory drugs (NSAIDs) are one of the most important classes of prescription drugs used by primary care physicians to manage pain. The NSAID class of products has a somewhat controversial history, around which a complex regulatory and informational environment has developed. This history includes a boxed warning mandated by the Food and Drug Administration (FDA) for all NSAIDs in 2005. We investigate the impact that various information shocks have had on the use of prescription medications for pain in primary care in the USA. We accomplish this by extracting data on nearly 600,000 patients from a unique nationwide electronic medical record database and estimate the probability of any active prescription for the four types of pain medications as a function of FDA actions, advertising, media coverage, and patient characteristics. We find that even after accounting for multiple sources of information, the FDA label changes and boxed warnings had a significant effect on pain medication prescribing. The boxed warning did not have the same impact on the use of all NSAID inhibitors. We find that the boxed warning reduced the use of NSAID COX-2 inhibitor use, which was the focus of much of the press attention. In contrast, however, the warning actually increased the use of non-COX-2 NSAID inhibitors. Thus, the efficacy of the FDA's black box warning is clearly mixed. PMID:25059655

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

    PubMed

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

    2015-07-01

    On September 16 and 17, 2014, the Food and Drug Administration (FDA) and Product Quality Research Institute (PQRI) inaugurated their Conference on Evolving Product Quality. The Conference is conceived as an annual forum in which scientists from regulatory agencies, industry, and academia may exchange viewpoints and work together to advance pharmaceutical quality. This Conference Summary Report highlights key topics of this conference, including (1) risk-based approaches to pharmaceutical development, manufacturing, regulatory assessment, and post-approval changes; (2) FDA-proposed quality metrics for products, facilities, and quality management systems; (3) performance-based quality assessment and clinically relevant specifications; (4) recent developments and implementation of continuous manufacturing processes, question-based review, and European Medicines Agency (EMA)-FDA pilot for Quality-by-Design (QbD) applications; and (5) breakthrough therapies, biosimilars, and international harmonization, focusing on ICH M7 and Q3D guidelines. The second FDA/PQRI conference on advancing product quality is planned for October 5-7, 2015. PMID:25840884

  7. Office of Native American Public Administration Programs as Required by Four Corners Regional Commission. Final Report.

    ERIC Educational Resources Information Center

    Winchell, Dick G.; Esse, Robert J.

    Arizona State University's (ASU's) Native American Public Administration Program (NAPAP) increased its level of services to the Navajo Nation in 1980 and expanded opportunities for public administration education for Native Americans on the ASU campus. The 1980 program had three major components: coursework, workshops, and the activities made…

  8. 26 CFR 301.7430-2 - Requirements and procedures for recovery of reasonable administrative costs.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... administrative costs is to obtain an award of such costs from the court. In the event the court awards reasonable... administrative proceeding, then an affidavit that specialized skills and distinctive knowledge as described in... limited availability of representatives possessing such skills and knowledge as described in that...

  9. 42 CFR 405.203 - FDA categorization of investigational devices.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational... the device as a factor in making Medicare coverage decisions. ... 42 Public Health 2 2010-10-01 2010-10-01 false FDA categorization of investigational devices....

  10. 21 CFR 5.1110 - FDA public information offices.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA public information offices. 5.1110 Section 5... ORGANIZATION Organization § 5.1110 FDA public information offices. (a) Division of Dockets Management. The Division of Dockets Management public room is located in rm. 1061, 5630 Fishers Lane, Rockville, MD...

  11. 76 FR 69040 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-07

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia Species Detection.'' This draft guidance document describes a means by which in vitro diagnostic devices for Yersinia species (spp.) detection may comply with the requirement of special controls for class II......

  12. 77 FR 16036 - Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device ISO...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

    ...--Requirements for regulatory purposes,'' (ISO 13485:2003) audit report provides FDA a degree of assurance of... Submission Program'' was published for comment in the Federal Register of May 20, 2010 (75 FR 28257... Administration Staff; Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program;...

  13. Post-training cocaine administration facilitates habit learning and requires the infralimbic cortex and dorsolateral striatum

    PubMed Central

    Schmitzer-Torbert, Neil; Apostolidis, Steven; Amoa, Romeo; O’Rear, Connor; Kaster, Michael; Stowers, Josh; Ritz, Robert

    2014-01-01

    Human drug addiction is a complex disorder, in which exogenous substances are able to recruit and maintain behaviors involved in drug taking. Many drugs that are addictive in humans are able to act on natural brain systems for learning and memory, and while many memory systems may be affected by addictive drugs, work with operant tasks has shown that addictive drugs (e.g. cocaine and alcohol) are particularly effective in recruiting habit learning systems, compared to natural rewards. It is currently unknown if the ability of addictive drugs to facilitate habit learning depends on a direct action on habit learning systems in the brain, versus the rewarding properties of drug administration. To differentiate between these options, rats were trained to perform two actions (lever pressing), each of which was rewarded with a different natural reward. After acquiring the behavior, rats received three training sessions which were followed by post-training injections of saline or cocaine (5 or 10 mg/kg, i.p.). Using sensory-specific satiety, extinction tests revealed that lever pressing for actions which were paired with saline were sensitive to devaluation (typical of goal-directed behaviors) while actions which were paired with cocaine were not sensitive to devaluation (typical of habitual behaviors). Lesions of the infralimbic or dorsolateral striatum were able to block the action of post-training cocaine injections. These data indicate that, within individual rats, cocaine injections facilitate the transition of behavior to habitual control for actions that have been recently performed, without a general facilitation of habit learning, and that this action of cocaine requires brain areas that are critical for learning natural habits. PMID:25460040

  14. Post-training cocaine administration facilitates habit learning and requires the infralimbic cortex and dorsolateral striatum.

    PubMed

    Schmitzer-Torbert, Neil; Apostolidis, Steven; Amoa, Romeo; O'Rear, Connor; Kaster, Michael; Stowers, Josh; Ritz, Robert

    2015-02-01

    Human drug addiction is a complex disorder, in which exogenous substances are able to recruit and maintain behaviors involved in drug taking. Many drugs that are addictive in humans are able to act on natural brain systems for learning and memory, and while many memory systems may be affected by addictive drugs, work with operant tasks has shown that addictive drugs (e.g. cocaine and alcohol) are particularly effective in recruiting habit learning systems, compared to natural rewards. It is currently unknown if the ability of addictive drugs to facilitate habit learning depends on a direct action on habit learning systems in the brain, versus the rewarding properties of drug administration. To differentiate between these options, rats were trained to perform two actions (lever pressing), each of which was rewarded with a different natural reward. After acquiring the behavior, rats received three training sessions which were followed by post-training injections of saline or cocaine (5 or 10mg/kg, i.p.). Using sensory-specific satiety, extinction tests revealed that lever pressing for actions which were paired with saline were sensitive to devaluation (typical of goal-directed behaviors) while actions which were paired with cocaine were not sensitive to devaluation (typical of habitual behaviors). Lesions of the infralimbic or dorsolateral striatum were able to block the action of post-training cocaine injections. These data indicate that, within individual rats, cocaine injections facilitate the transition of behavior to habitual control for actions that have been recently performed, without a general facilitation of habit learning, and that this action of cocaine requires brain areas that are critical for learning natural habits. PMID:25460040

  15. Bringing smart pills to market: FDA regulation of ingestible drug/device combination products.

    PubMed

    Avery, Matthew; Liu, Dan

    2011-01-01

    Imagine a pill that, after you swallow it, can track its position in your body. Or imagine a pill that can transmit a message to a doctor to tell him that you have taken your bitter medicine. Pills like this already exist. These so-called smart pills are an emerging type of medical therapy. However, this nascent technology has yet to reach the market and developers of these novel therapies face significant regulatory challenges. This article predicts how the Food and Drug Administration will regulate smart pills and shows how the current regulatory regime is inadequate. The article then proposes modifying the current regulatory regime to encourage development of smart pills and other innovative combination products by: (1) regulating combination products based on their "novel mode of action" rather than their "primary mode of action," (2) creating a marketing approval pathway specifically for combination products, and (3) eliminating regulations that require sponsors to get marketing approval from multiple centers within FDA and providing regulatory guidance specifically for ingestible drug/device combination products. PMID:24505852

  16. Towards a Computational Analysis of Status and Leadership Styles on FDA Panels

    NASA Astrophysics Data System (ADS)

    Broniatowski, David A.; Magee, Christopher L.

    Decisions by committees of technical experts are increasingly impacting society. These decision-makers are typically embedded within a web of social relations. Taken as a whole, these relations define an implicit social structure which can influence the decision outcome. Aspects of this structure are founded on interpersonal affinity between parties to the negotiation, on assigned roles, and on the recognition of status characteristics, such as relevant domain expertise. This paper build upon a methodology aimed at extracting an explicit representation of such social structures using meeting transcripts as a data source. Whereas earlier results demonstrated that the method presented here can identify groups of decision-makers with a contextual affinity (i.e., membership in a given medical specialty or voting clique), we now can extract meaningful status hierarchies, and can identify differing facilitation styles among committee chairs. Use of this method is demonstrated on the transcripts of U.S. Food and Drug Administration (FDA) advisory panel meeting transcripts; nevertheless, the approach presented here is extensible to other domains and requires only a meeting transcript as input.

  17. A fuzzy logic controller for hormone administration using an implantable pump

    NASA Technical Reports Server (NTRS)

    Coles, L. Stephen; Wells, George H., Jr.

    1994-01-01

    This paper describes the requirements for a Fuzzy Logic Controller for the physiologic administration of hormones by means of a FDA-approved surgically implantable infusion pump. Results of a LabVIEW computer simulation for the administration of insulin for diabetic adult patients as well as human growth hormone for pediatric patients are presented. A VHS video tape of the simulation in action has been prepared and is available for viewing.

  18. Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012

    PubMed Central

    Miller, Jennifer E; Korn, David; Ross, Joseph S

    2015-01-01

    Objective To evaluate clinical trial registration, reporting and publication rates for new drugs by: (1) legal requirements and (2) the ethical standard that all human subjects research should be publicly accessible to contribute to generalisable knowledge. Design Cross-sectional analysis of all clinical trials submitted to the Food and Drug Administration (FDA) for drugs approved in 2012, sponsored by large biopharmaceutical companies. Data sources Information from Drugs@FDA, ClinicalTrials.gov, MEDLINE-indexed journals and drug company communications. Main outcome measures Clinical trial registration and results reporting in ClinicalTrials.gov, publication in the medical literature, and compliance with the 2007 FDA Amendments Acts (FDAAA), analysed on the drug level. Results The FDA approved 15 drugs sponsored by 10 large companies in 2012. We identified 318 relevant trials involving 99 599 research participants. Per drug, a median of 57% (IQR 32–83%) of trials were registered, 20% (IQR 12–28%) reported results in ClinicalTrials.gov, 56% (IQR 41–83%) were published, and 65% (IQR 41–83%) were either published or reported results. Almost half of all reviewed drugs had at least one undisclosed phase II or III trial. Per drug, a median of 17% (IQR 8–20%) of trials supporting FDA approvals were subject to FDAAA mandated public disclosure; of these, a median of 67% (IQR 0–100%) were FDAAA-compliant. 68% of research participants (67 629 of 99 599) participated in FDAAA-subject trials, with 51% (33 405 of 67 629) enrolled in non-compliant trials. Transparency varied widely among companies. Conclusions Trial disclosures for new drugs remain below legal and ethics standards, with wide variation in practices among drugs and their sponsors. Best practices are emerging. 2 of our 10 reviewed companies disclosed all trials and complied with legal disclosure requirements for their 2012 approved drugs. Ranking new drugs on transparency criteria may improve

  19. 21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... requirements for medical devices held by the Strategic National Stockpile. 801.128 Section 801.128 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... requirements for medical devices held by the Strategic National Stockpile. (a) The appropriate FDA...

  20. 21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... requirements for medical devices held by the Strategic National Stockpile. 801.128 Section 801.128 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... requirements for medical devices held by the Strategic National Stockpile. (a) The appropriate FDA...

  1. 21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... requirements for medical devices held by the Strategic National Stockpile. 801.128 Section 801.128 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... requirements for medical devices held by the Strategic National Stockpile. (a) The appropriate FDA...

  2. 21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... requirements for medical devices held by the Strategic National Stockpile. 801.128 Section 801.128 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... requirements for medical devices held by the Strategic National Stockpile. (a) The appropriate FDA...

  3. 21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... requirements for medical devices held by the Strategic National Stockpile. 801.128 Section 801.128 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... requirements for medical devices held by the Strategic National Stockpile. (a) The appropriate FDA...

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

    Knoepfler, Paul S

    2015-03-01

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

  6. Hospital Providers: The Day After FDA Approval

    PubMed Central

    DeKoven, Mitchell; McCagh, Brian; Zoch, Jeremy

    2005-01-01

    Hospitals have a lot at stake when new biologic drugs and devices hit the market. Cooperation among medical and administrative leaders can help providers avoid some harrowing financial pitfalls – while improving patient satisfaction. PMID:23393477

  7. 45 CFR 1356.40 - Adoption assistance program: Administrative requirements to implement section 473 of the Act.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... SERVICES THE ADMINISTRATION ON CHILDREN, YOUTH AND FAMILIES, FOSTER CARE MAINTENANCE PAYMENTS, ADOPTION.... (c) There must be no income eligibility requirement (means test) for the prospective adoptive parent... adopting parent(s) who reside in another State. If so, all provisions of this section apply. (f) The...

  8. The Effects of the Chapter 2, ECIA Consolidation on the Administrative and Paperwork Requirements for Local School Districts.

    ERIC Educational Resources Information Center

    Hastings, Anne H.; Bartell, Ted

    The purpose of this report is to analyze how the administrative and paperwork requirements with which local school districts must comply have been affected by the consolidation of 28 federal education programs into the Chapter 2, Education Consolidation and Improvement Act (ECIA) block grant. The information reported is based on interviews with…

  9. 10 CFR 35.392 - Training for the oral administration of sodium iodide I-131 requiring a written directive in...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries). 35.392 Section 35.392 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Unsealed Byproduct Material-Written...

  10. 10 CFR 35.392 - Training for the oral administration of sodium iodide I-131 requiring a written directive in...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries). 35.392 Section 35.392 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Unsealed Byproduct Material-Written...

  11. 10 CFR 35.392 - Training for the oral administration of sodium iodide I-131 requiring a written directive in...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries). 35.392 Section 35.392 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Unsealed Byproduct Material-Written...

  12. 10 CFR 35.392 - Training for the oral administration of sodium iodide I-131 requiring a written directive in...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries). 35.392 Section 35.392 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Unsealed Byproduct Material-Written...

  13. 10 CFR 35.392 - Training for the oral administration of sodium iodide I-131 requiring a written directive in...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries). 35.392 Section 35.392 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Unsealed Byproduct Material-Written...

  14. The Perceptions of Key Hospital Leaders as to the Competencies Required for Hospital Administration and Their Implications for Professional Education.

    ERIC Educational Resources Information Center

    Austin, Theodore Arnold

    This study sought to define competencies hospital executives need to perform their role effectively as perceived by hospital leaders, and to analyze the implications of these competency requirements for the professional education of hospital administrators. A semi-projective questionnaire was devised with the help of a panel of 10 administrators…

  15. Cardiovascular devices; reclassification of nonroller-type cardiopulmonary bypass blood pumps for cardiopulmonary and circulatory bypass; effective date of requirement for premarket approval for nonroller-type cardiopulmonary bypass blood pumps for temporary ventricular support. Final order.

    PubMed

    2015-06-01

    The Food and Drug Administration (FDA) is issuing a final order to reclassify nonroller-type cardiopulmonary bypass blood pump (NRP) devices for cardiopulmonary and circulatory bypass, a preamendments class III device, into class II (special controls), and to require the filing of a premarket approval application (PMA) for NRP devices for temporary ventricular support. FDA is also revising the title and identification of the regulation for NRP devices in this order. PMID:26054096

  16. 76 FR 53912 - FDA's Public Database of Products With Orphan-Drug Designation: Replacing Non-Informative Code...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-30

    ... HUMAN SERVICES Food and Drug Administration FDA's Public Database of Products With Orphan-Drug... its public database of products that have received orphan-drug designation. The Orphan Drug Act... received orphan designation were published on our public database with non-informative code names....

  17. 21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What expedited procedures apply when FDA initiates a seizure action against a detained perishable food? 1.383 Section 1.383 Food and Drugs FOOD AND... Administrative Detention of Food for Human or Animal Consumption General Provisions § 1.383 What...

  18. 76 FR 41506 - Draft Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and FDA Staff on In Vitro... entitled ``In Vitro Companion Diagnostic Devices.'' This guidance is intended to assist sponsors planning to develop a therapeutic product that depends on the use of an in vitro companion diagnostic...

  19. Food and Drug Administration

    MedlinePlus

    ... safety rule implementation September 02, 2016 - FDA allows marketing of clot retrieval devices to reduce disability in ... feeds Follow FDA on Twitter Follow FDA on Facebook View FDA videos on YouTube View FDA photos ...

  20. 42 CFR 137.405 - Is the Secretary required to report to Congress on administration of Title V and the funding...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... administration of Title V and the funding requirements presently funded or unfunded? 137.405 Section 137.405... Is the Secretary required to report to Congress on administration of Title V and the funding... report regarding the administration of Title V. The report shall include a detailed analysis of...

  1. 42 CFR 137.405 - Is the Secretary required to report to Congress on administration of Title V and the funding...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... administration of Title V and the funding requirements presently funded or unfunded? 137.405 Section 137.405... Is the Secretary required to report to Congress on administration of Title V and the funding... report regarding the administration of Title V. The report shall include a detailed analysis of...

  2. 42 CFR 137.405 - Is the Secretary required to report to Congress on administration of Title V and the funding...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... administration of Title V and the funding requirements presently funded or unfunded? 137.405 Section 137.405... Is the Secretary required to report to Congress on administration of Title V and the funding... report regarding the administration of Title V. The report shall include a detailed analysis of...

  3. 42 CFR 137.405 - Is the Secretary required to report to Congress on administration of Title V and the funding...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... administration of Title V and the funding requirements presently funded or unfunded? 137.405 Section 137.405... Is the Secretary required to report to Congress on administration of Title V and the funding... report regarding the administration of Title V. The report shall include a detailed analysis of...

  4. 42 CFR 137.405 - Is the Secretary required to report to Congress on administration of Title V and the funding...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... administration of Title V and the funding requirements presently funded or unfunded? 137.405 Section 137.405... Is the Secretary required to report to Congress on administration of Title V and the funding... report regarding the administration of Title V. The report shall include a detailed analysis of...

  5. Complementary and integrative medical therapies, the FDA, and the NIH: definitions and regulation.

    PubMed

    Cohen, Michael H

    2003-01-01

    The National Center for Complementary and Alternative Medicine (NCCAM) presently defines complementary and alternative medicine (CAM) as covering "a broad range of healing philosophies (schools of thought), approaches, and therapies that mainstream Western (conventional) medicine does not commonly use, accept, study, understand, or make available. The research landscape, including NCCAM-funded research, is continually changing and subject to vigorous methodologic and interpretive debates. Part of the impetus for greater research dollars in this arena has been increasing consumer reliance on CAM to dramatically expand. State (not federal) law controls much of CAM practice. However, a significant federal role exists in the regulation of dietary supplements. The U.S. Food and Drug Administration (FDA) regulates foods, drugs, and cosmetics in interstate commerce. No new "drug" may be introduced into interstate commerce unless proven "safe" and "effective" for its intended use, as determined by FDA regulations. "Foods", however, are subject to different regulatory requirements, and need not go through trials proving safety and efficacy. The growing phenomenon of consumer use of vitamins, minerals, herbs, and other "dietary supplements" challenged the historical divide between drugs and foods. The federal Dietary Supplements Health Education Act (DSHEA) allows manufacturers to distribute dietary supplements without having to prove safety and efficacy, so long as the manufacturers make no claims linking the supplements to a specific disease. State law regulates the use of CAM therapies through a variety of legal rules. Of these, several major areas of concern for clinicians are professional licensure, scope of practice, and malpractice. Regarding licensure, each state has enacted medical licensing that prohibits the unlicensed practice of medicine and thereby criminalizes activity by unlicensed CAM providers who offer health care services to patients. Malpractice is

  6. Nanoparticle-Based Medicines: A Review of FDA-Approved Materials and Clinical Trials to Date.

    PubMed

    Bobo, Daniel; Robinson, Kye J; Islam, Jiaul; Thurecht, Kristofer J; Corrie, Simon R

    2016-10-01

    In this review we provide an up to date snapshot of nanomedicines either currently approved by the US FDA, or in the FDA clinical trials process. We define nanomedicines as therapeutic or imaging agents which comprise a nanoparticle in order to control the biodistribution, enhance the efficacy, or otherwise reduce toxicity of a drug or biologic. We identified 51 FDA-approved nanomedicines that met this definition and 77 products in clinical trials, with ~40% of trials listed in clinicaltrials.gov started in 2014 or 2015. While FDA approved materials are heavily weighted to polymeric, liposomal, and nanocrystal formulations, there is a trend towards the development of more complex materials comprising micelles, protein-based NPs, and also the emergence of a variety of inorganic and metallic particles in clinical trials. We then provide an overview of the different material categories represented in our search, highlighting nanomedicines that have either been recently approved, or are already in clinical trials. We conclude with some comments on future perspectives for nanomedicines, which we expect to include more actively-targeted materials, multi-functional materials ("theranostics") and more complicated materials that blur the boundaries of traditional material categories. A key challenge for researchers, industry, and regulators is how to classify new materials and what additional testing (e.g. safety and toxicity) is required before products become available. PMID:27299311

  7. ArrayTrack: a free FDA bioinformatics tool to support emerging biomedical research--an update.

    PubMed

    Xu, Joshua; Kelly, Reagan; Fang, Hong; Tong, Weida

    2010-08-01

    ArrayTrack is a Food and Drug Administration (FDA) bioinformatics tool that has been widely adopted by the research community for genomics studies. It provides an integrated environment for microarray data management, analysis and interpretation. Most of its functionality for statistical, pathway and gene ontology analysis can also be applied independently to data generated by other molecular technologies. ArrayTrack has been undergoing active development and enhancement since its inception in 2001. This review summarises its key functionalities, with emphasis on the most recent extensions in support of the evolving needs of FDA's research programmes. ArrayTrack has added capability to manage, analyse and interpret proteomics and metabolomics data after quantification of peptides and metabolites abundance, respectively. Annotation information about single nucleotide polymorphisms and quantitative trait loci has been integrated to support genetics-related studies. Other extensions have been added to manage and analyse genomics data related to bacterial food-borne pathogens. PMID:20846933

  8. FDA direct-to-consumer advertising for prescription drugs: what are consumer preferences and response tendencies?

    PubMed

    Khanfar, Nile; Loudon, David; Sircar-Ramsewak, Feroza

    2007-01-01

    The effect of direct-to-consumer (DTC) television advertising of prescription medications is a growing concern of the United States (U.S.) Congress, state legislatures, and the Food and Drug Administration (FDA). This research study was conducted in order to examine consumers' perceived preferences of DTC television advertisement in relation to "reminder" "help-seeking," and "product-claim" FDA-approved advertisement categories. An additional objective was to examine the influence of DTC television advertising of prescription drugs on consumers' tendency to seek more information about the medication and/or the medical condition. The research indicates that DTC television drug ads appear to be insufficient for consumers to make informed decisions. Their mixed perception and acceptance of the advertisements seem to influence them to seek more information from a variety of medical sources. PMID:19042521

  9. Petitioning the FDA to Improve Pharmaceutical, Device and Public Health Safety by Ordinary Citizens: A Descriptive Analysis

    PubMed Central

    Yang, Y. Tony; Cheng, Xi; Bian, John; Bennett, Charles L.

    2016-01-01

    The United States Constitution protects the right of citizens to petition the government for “a redress of grievances.” This right has important implications for citizens desiring to advance the public health by petitioning administrative agencies, such as the Food and Drug Administration, to take safety actions. We examined a total of 1,915 petitions filed between 2001 and 2013 to investigate the outcomes of citizen petitions that address public health concerns. We found that most petitions were filed by manufacturers against other manufacturers. Only 346 (18%) of all petitions were submitted by individuals and non-profit organizations, and 178 (87.3%) of these petitions with a final response were denied. On average, these petitions required 2.85 years for a final agency decision, and many decisions remain pending 10–13 years after their initial submission. The great majority of the approved requests included some form of risk communication, such as labeling changes, boxed warnings or placement of a drug into a Risk Evaluation and Mitigation Strategy. As a policy instrument to improve the safety of medical and food products, the citizen petition process requires sophisticated legal and scientific expertise, and may not represent a viable route for ordinary citizens to petition the FDA to “redress grievances.” PMID:27171162

  10. Petitioning the FDA to Improve Pharmaceutical, Device and Public Health Safety by Ordinary Citizens: A Descriptive Analysis.

    PubMed

    Chen, Brian K; Yang, Y Tony; Cheng, Xi; Bian, John; Bennett, Charles L

    2016-01-01

    The United States Constitution protects the right of citizens to petition the government for "a redress of grievances." This right has important implications for citizens desiring to advance the public health by petitioning administrative agencies, such as the Food and Drug Administration, to take safety actions. We examined a total of 1,915 petitions filed between 2001 and 2013 to investigate the outcomes of citizen petitions that address public health concerns. We found that most petitions were filed by manufacturers against other manufacturers. Only 346 (18%) of all petitions were submitted by individuals and non-profit organizations, and 178 (87.3%) of these petitions with a final response were denied. On average, these petitions required 2.85 years for a final agency decision, and many decisions remain pending 10-13 years after their initial submission. The great majority of the approved requests included some form of risk communication, such as labeling changes, boxed warnings or placement of a drug into a Risk Evaluation and Mitigation Strategy. As a policy instrument to improve the safety of medical and food products, the citizen petition process requires sophisticated legal and scientific expertise, and may not represent a viable route for ordinary citizens to petition the FDA to "redress grievances." PMID:27171162

  11. 34 CFR 682.610 - Administrative and fiscal requirements for participating schools.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... regulations in this part and in 34 CFR part 668; (2) Follow the record retention and examination provisions in this part and in 34 CFR 668.24; and (3) Submit all reports required by this part and 34 CFR part 668 to the Secretary. (b) Loan record requirements. In addition to records required by 34 CFR part 668,...

  12. 34 CFR 682.610 - Administrative and fiscal requirements for participating schools.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... regulations in this part and in 34 CFR part 668; (2) Follow the record retention and examination provisions in this part and in 34 CFR 668.24; and (3) Submit all reports required by this part and 34 CFR part 668 to the Secretary. (b) Loan record requirements. In addition to records required by 34 CFR part 668,...

  13. 34 CFR 682.610 - Administrative and fiscal requirements for participating schools.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... regulations in this part and in 34 CFR part 668; (2) Follow the record retention and examination provisions in this part and in 34 CFR 668.24; and (3) Submit all reports required by this part and 34 CFR part 668 to the Secretary. (b) Loan record requirements. In addition to records required by 34 CFR part 668,...

  14. 45 CFR 1336.69 - Reporting requirements: Responsibilities of the Loan Administrator.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... (Continued) OFFICE OF HUMAN DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION... expenditures; (ii) Level of base capital; (iii) Level of current capital; (iv) Amount of ANA funding; (v... all outstanding loans, noting all overdue payments. (3) Monthly status of the investments of...

  15. 45 CFR 1336.69 - Reporting requirements: Responsibilities of the Loan Administrator.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... (Continued) OFFICE OF HUMAN DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION... expenditures; (ii) Level of base capital; (iii) Level of current capital; (iv) Amount of ANA funding; (v... all outstanding loans, noting all overdue payments. (3) Monthly status of the investments of...

  16. 45 CFR 1336.69 - Reporting requirements: Responsibilities of the Loan Administrator.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... (Continued) OFFICE OF HUMAN DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION... expenditures; (ii) Level of base capital; (iii) Level of current capital; (iv) Amount of ANA funding; (v... all outstanding loans, noting all overdue payments. (3) Monthly status of the investments of...

  17. Required Preliminary Administrative Service Credential Program Culminating Activities in California NCATE Accredited Universities

    ERIC Educational Resources Information Center

    Wildman, Louis

    2014-01-01

    The purpose of this effort is to share information about the variety of culminating activities used in the acquisition of the California Preliminary Administrative Services Credential. Knowledge of these varying culminating activities and related practices has not previously been readily available. The culminating activities among…

  18. 34 CFR 461.40 - What are the State and local administrative costs requirements?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... (Continued) OFFICE OF VOCATIONAL AND ADULT EDUCATION, DEPARTMENT OF EDUCATION ADULT EDUCATION STATE...'s award from the SEA must be expended for adult education instructional activities. (2) The... 34 Education 3 2010-07-01 2010-07-01 false What are the State and local administrative...

  19. 20 CFR 641.800 - What uniform administrative requirements apply to the use of SCSEP funds?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... ADMINISTRATION, DEPARTMENT OF LABOR PROVISIONS GOVERNING THE SENIOR COMMUNITY SERVICE EMPLOYMENT PROGRAM... with State and Local Governments” (10/07/1994) (further amended 08/29/1977), codified at 29 CFR part 97... agreements must follow the common rule implementing OMB Circular A-110, codified at 2 CFR part 215 and 29...

  20. 22 CFR 46.7 - Instructions from the Administrator required in certain cases.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...), 11 (4), or 11(5) of the Agreement between the United Nations and the United States of America... certain cases. 46.7 Section 46.7 Foreign Relations DEPARTMENT OF STATE VISAS CONTROL OF ALIENS DEPARTING... absence of appropriate instructions from the Administrator of the Bureau of Security and Consular...

  1. Establishment, maintenance, and availability of records: amendment to record availability requirements. Interim final rule; request for comments.

    PubMed

    2012-02-23

    The Food and Drug Administration (FDA) is amending its regulations on establishment, maintenance, and availability of records. FDA is issuing this interim final rule (IFR) to amend FDA's regulation on the record availability requirements to implement the amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) made by the FDA Food Safety Modernization Act (FSMA). The FSMA amendment expands FDA's former records access authority beyond records relating to the specific suspect article of food to records relating to any other article of food that the Secretary of Health and Human Services (the Secretary) reasonably believes is likely to be affected in a similar manner. In addition, the FSMA amendment permits FDA to access records relating to articles of food for which the Secretary believes that there is a reasonable probability that the use of or exposure to the article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals. This expanded records access authority will further help improve FDA's ability to respond to, and further contain threats of serious adverse health consequences or death to humans or animals. PMID:22379688

  2. 76 FR 67197 - Small Entity Compliance Guide: Required Warnings for Cigarette Packages and Advertisements...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-31

    ...The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of October 25, 2011 (76 FR 66074). The document announced the availability of a guidance for industry entitled ``Required Warnings for Cigarette Packages and Advertisements--Small Entity Compliance Guide'' for a final rule that published in the Federal Register of June 22, 2011 (76 FR 36628).......

  3. 21 CFR 25.20 - Actions requiring preparation of an environmental assessment.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Actions requiring preparation of an environmental assessment. 25.20 Section 25.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... request, unless categorically excluded in §§ 25.30(d) or 25.32(h). (d) Disposition of FDA laboratory...

  4. 21 CFR 25.20 - Actions requiring preparation of an environmental assessment.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Actions requiring preparation of an environmental assessment. 25.20 Section 25.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... request, unless categorically excluded in §§ 25.30(d) or 25.32(h). (d) Disposition of FDA laboratory...

  5. Ultraviolet light-an FDA approved technology

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Ultraviolet Light (254 nm) is a U.S. Food and Drug Administration approved nonthermal intervention technology that can be used for decontamination of food and food contact surfaces. Ultraviolet light is a green technology that leaves no chemical residues. Results from our laboratory indicate that ex...

  6. FDA cautions against ultrasounds 'keepsake' images.

    PubMed

    Rados, Carol

    2004-01-01

    It's risky business taking pictures of unborn babies when there's no medical need to do so. That's the word from the Food and Drug Administration, which is concerned about companies trying to turn an important medical procedure into a prenatal portrait tool. PMID:15032198

  7. The Facts on the FDA's New Tobacco Rule

    MedlinePlus

    ... agency authority to regulate the manufacturing, distribution, and marketing of tobacco products. Today, the rule does several ... law. And those manufacturers will have to receive marketing authorization from the FDA. The new rule also ...

  8. FDA Approves Experimental Zika Test for Blood Donations

    MedlinePlus

    ... html FDA Approves Experimental Zika Test for Blood Donations But agency still asks those who've possibly ... HealthDay News) -- An experimental test to check blood donations for the Zika virus has been approved by ...

  9. What FDA Learned About Dark Chocolate and Milk Allergies

    MedlinePlus

    ... Updates What FDA Learned About Dark Chocolate and Milk Allergies Share Tweet Linkedin Pin it More sharing ... to top No Message Doesn’t Mean No Milk You shouldn’t assume that dark chocolate contains ...

  10. FDA Calls for Less Salt in Processed Foods

    MedlinePlus

    ... news/fullstory_159136.html FDA Calls for Less Salt in Processed Foods Agency sets short- and long- ... the food industry to cut back on the salt. In draft voluntary guidelines issued Wednesday, the agency ...

  11. Drug for Yeast Infections May Raise Miscarriage Risk, FDA Warns

    MedlinePlus

    ... gov/medlineplus/news/fullstory_158503.html Drug for Yeast Infections May Raise Miscarriage Risk, FDA Warns Agency recommends ... brand name Diflucan) is used to treat vaginal yeast infections. "Patients who are pregnant or actively trying to ...

  12. FDA Approves New Drug to Treat Bladder Cancer

    MedlinePlus

    ... gov/medlineplus/news/fullstory_158937.html FDA Approves New Drug to Treat Bladder Cancer Tecentriq boosted survival ... 2016 THURSDAY, May 19, 2016 (HealthDay News) -- A new drug to treat bladder cancer was approved by ...

  13. Think Twice Before You Get That Tattoo: FDA

    MedlinePlus

    ... 159272.html Think Twice Before You Get That Tattoo: FDA Though popular, they carry infection risks and ... 8, 2016 WEDNESDAY, June 8, 2016 (HealthDay News) -- Tattoos are increasingly popular in the United States, but ...

  14. FDA to Re-Examine What Makes a Food 'Healthy'

    MedlinePlus

    ... should be labeled "healthy"? Raisin bran? Avocados? Granola bars? Going by current -- and perhaps outdated -- U.S. food- ... healthy" is Kind LLC, a producer of granola bars, which was warned by the FDA last year ...

  15. Effect of the FDA on health care investments

    NASA Astrophysics Data System (ADS)

    Cleary, David J.

    1994-12-01

    The cost of securing FDA approval has long been an important consideration in funding projects involving new medical technologies, but the more stringent regulatory behavior of the FDA in the past few years has led to a discernable decrease in the funding of start-up medical device companies. An abundance of anecdotal evidence, supported with surveys of venture capital firms, investment groups and medical device corporations, indicates a serious shortage of funds available for the development of certain medical technologies.

  16. 77 FR 70166 - Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-23

    ...The Food and Drug Administration (FDA) is establishing a public docket for information pertaining to FDA's implementation of the provisions of the Food and Drug Administration Safety and Innovation Act (FDASIA) related to medical gases. This action is intended to ensure that information submitted to FDA on the implementation of the medical gas provisions of FDASIA is available to all......

  17. 48 CFR 227.7004 - Requirements for filing an administrative claim for patent infringement.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Requirements for filing an..., DATA, AND COPYRIGHTS Infringement Claims, Licenses, and Assignments 227.7004 Requirements for filing an... information at the time of filing a claim to permit the most expeditious processing and settlement of...

  18. 26 CFR 1.7519-2T - Required payments-procedures and administration (temporary).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Negligence and fraud penalties made applicable. For purposes of section 6653, relating to additions to tax for negligence and fraud, any payment required by this section shall be treated as a tax. ... TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES The Tax Court § 1.7519-2T Required...

  19. National Aeronautics and Space Administration Manned Spacecraft Center data based requirements study

    NASA Technical Reports Server (NTRS)

    1971-01-01

    The results are summarized of a study to determine the requirements of a data management system to meet the needs of MSC in mission planning and program and resource management during the 1975 time frame. The study addresses overall system requirements, implementation considerations, and cost/benefit comparisions.

  20. New aquaculture drugs under FDA review

    USGS Publications Warehouse

    Bowker, James D.; Gaikowski, Mark P.

    2012-01-01

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

  1. 26 CFR 1.414(r)-6 - Qualified separate line of business-administrative scrutiny requirement-individual determinations.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...-administrative scrutiny requirement-individual determinations. 1.414(r)-6 Section 1.414(r)-6 Internal Revenue... (CONTINUED) Pension, Profit-Sharing, Stock Bonus Plans, Etc. § 1.414(r)-6 Qualified separate line of business... determined under § 1.414(r)-3) that does not satisfy any of the safe harbors in § 1.414(r)-5 for a...

  2. 26 CFR 1.414(r)-6 - Qualified separate line of business-administrative scrutiny requirement-individual determinations.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...-administrative scrutiny requirement-individual determinations. 1.414(r)-6 Section 1.414(r)-6 Internal Revenue... (CONTINUED) Pension, Profit-Sharing, Stock Bonus Plans, Etc. § 1.414(r)-6 Qualified separate line of business... determined under § 1.414(r)-3) that does not satisfy any of the safe harbors in § 1.414(r)-5 for a...

  3. 26 CFR 1.414(r)-6 - Qualified separate line of business-administrative scrutiny requirement-individual determinations.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...-administrative scrutiny requirement-individual determinations. 1.414(r)-6 Section 1.414(r)-6 Internal Revenue... (CONTINUED) Pension, Profit-Sharing, Stock Bonus Plans, Etc. § 1.414(r)-6 Qualified separate line of business... determined under § 1.414(r)-3) that does not satisfy any of the safe harbors in § 1.414(r)-5 for a...

  4. FDA Approval Summary: Pembrolizumab for the Treatment of Patients With Metastatic Non-Small Cell Lung Cancer Whose Tumors Express Programmed Death-Ligand 1

    PubMed Central

    Blumenthal, Gideon M.; Jiang, Xiaoping; He, Kun; Keegan, Patricia; Pazdur, Richard

    2016-01-01

    On October 2, 2015, the U.S. Food and Drug Administration (FDA) granted accelerated approval for pembrolizumab, a breakthrough therapy-designated drug, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express programmed death-ligand 1 (PD-L1), as determined by an FDA-approved test, and who have disease progression on or after platinum-containing chemotherapy or targeted therapy against anaplastic lymphoma kinase or epidermal growth factor receptor, if appropriate. This indication was approved concurrently with the PD-L1 immunohistochemistry 22C3 pharmDx, a companion diagnostic test for patient selection based on PD-L1 tumor expression. The accelerated approval was granted based on durable objective response rate (ORR) and an acceptable toxicity profile demonstrated in a multicenter, open-label trial enrolling 550 patients with metastatic NSCLC. The efficacy population comprised 61 patients with tumors identified as strongly positive for PD-L1, and the confirmed ORR as determined by blinded independent central review was 41% (95% confidence interval: 28.6%, 54.3%); all were partial responses. At the time of the analysis, responses were ongoing in 21 of 25 patients (84%), with 11 patients (44%) having response duration of ≥6 months. The most commonly occurring (≥20%) adverse reactions included fatigue, decreased appetite, dyspnea, and cough. The most frequent (≥2%) serious adverse drug reactions were pleural effusion, pneumonia, dyspnea, pulmonary embolism, and pneumonitis. Immune-mediated adverse reactions occurred in 13% of patients and included pneumonitis, colitis, hypophysitis, and thyroid disorders. The accelerated approval regulations describe approval of drugs and biologic products for serious and life-threatening illnesses based on a surrogate endpoint likely to predict clinical benefit. Under these regulations, a confirmatory trial or trials is required to verify and describe the benefit of pembrolizumab

  5. 76 FR 50740 - Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-16

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Section 522 Postmarket Surveillance Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  6. 78 FR 44574 - Third Annual Food and Drug Administration Health Professional Organizations Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-24

    ... HUMAN SERVICES Food and Drug Administration Third Annual Food and Drug Administration Health Professional Organizations Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of conference. The Food and Drug Administration (FDA) is announcing a conference for representatives of...

  7. 76 FR 55928 - Food and Drug Administration Health Professional Organizations Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Health Professional Organizations Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. The Food and Drug Administration (FDA) is announcing a conference for representatives of...

  8. 77 FR 47652 - Second Annual Food and Drug Administration Health Professional Organizations Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-09

    ... HUMAN SERVICES Food and Drug Administration Second Annual Food and Drug Administration Health Professional Organizations Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of conference. The Food and Drug Administration (FDA) is announcing a conference for representatives of...

  9. Medical devices; revocation of cardiac pacemaker registry. Food and Drug Administration, HHS. Final rule.

    PubMed

    1999-11-24

    The Food and Drug Administration (FDA) is issuing a final rule to revoke a regulation requiring a cardiac pacemaker registry. The registry, which was mandated by the Deficit Reduction Act of 1984, requires any physician and any provider of services who requests or receives Medicare payment for an implantation, removal, or replacement of permanent cardiac pacemaker devices and pacemaker leads to submit certain information to the registry. The information is used by FDA to track the performance of permanent cardiac pacemakers and pacemaker leads and by the Health Care Finance Administration (HCFA) to administer its Medicare payment program for these devices. This action is being taken to implement an act to Repeal An Unnecessary Medical Device Reporting Requirement passed by Congress in 1996 to remove the cardiac pacemaker registry to eliminate duplicative and unnecessary reporting. PMID:11010690

  10. The crime of saving lives. The FDA, John Najarian, and Minnesota ALG.

    PubMed

    Wilson, L G

    1995-10-01

    The indictment of John Najarian, MD, and Richard Condie at Minneapolis, Minn, on April 10, 1995, was a defining episode in the prolonged agony that has ensued since August 1992, when the federal Food and Drug Administration (FDA) placed Minnesota Anti-Lymphocyte Globulin (MALG) on clinical hold, bringing to an end its use as an immunosuppressive agent for patients undergoing transplantation. The principal charge in the indictment is that from about 1968 until 1992--the whole period of the development and use of MALG--Dr Najarian and Mr Condie conspired to defraud the United States by impeding the FDA in its oversight of biological drugs and that they did so for the purpose of financial gain. If the charges can be considered seriously, they mean that Dr Najarian's purpose in the development and manufacture of MALG was to make money, presumably for himself, and that the possible benefit of MALG to the patients was of secondary concern to him. Several difficulties arise immediately. In 1968, MALG offered a promising new approach to immunosuppression. In a relatively crude form, it had been used at the University of Colorado with striking improvement in the survival of patients undergoing transplantation and transplanted organs, but it was painful to administer by intramuscular injections and, in addition to other side effects, produced muscular spasms. Dr Najarian and his colleagues succeeded in purifying MALG so that the pure globulin could be injected into a central vein. The process of purification was complicated and expensive, so it was hardly practical for each transplant center to produce MALG for itself. Thus, in 1969, when Dr Najarian submitted an investigational new drug application (IND) to the FDA, he stated that his purpose was to manufacture MALG not only for patients at the University of Minnesota Hospital but also for patients at other transplant centers, which were not in a position to make it for themselves. He asked the FDA to approve recovery of

  11. 21 CFR 20.108 - Agreements between the Food and Drug Administration and other departments, agencies, and...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Food and Drug Administration Web site at http://www.fda.gov once finalized. (c) Agreements and... understandings will not be made available through the FDA Web site, these agreements will be available...

  12. Review of non-FDA-approved fillers.

    PubMed

    Ellis, David A F; Segall, Lorne

    2007-05-01

    The number of commercially available injectable soft tissue fillers has increased dramatically worldwide over the past decade. In the United States, a variety of temporary non-collagen-based fillers have been approved. However, no permanent soft tissue injectable fillers are currently approved by the US Food and Drug Administration. This article discusses some of the more popular soft tissue fillers, such as Restylane Fine Line, Restylane SQ, Perlane, Artecoll, Dermalive, Dermadeep, Bioalcamid, Bioplastique, Evolution, Outline, Argiform, and Aquamid, which are all available outside of the United States. PMID:17544940

  13. 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. PMID:24475548

  14. Effects of FDA Advisories on the Pharmacologic Treatment of ADHD, 2004–2008

    PubMed Central

    Kornfield, Rachel; Watson, Sydeaka; Higashi, Ashley S.; Conti, Rena M.; Dusetzina, Stacie B.; Garfield, Craig F.; Dorsey, E. Ray; Huskamp, Haiden A.; Alexander, G. Caleb

    2014-01-01

    Objective This study assessed the effect of public health advisories issued between 2005 and 2007 by the U.S. Food and Drug Administration (FDA) on treatments of attention-deficit hyperactivity disorder (ADHD) and physician prescribing practices. Methods Data obtained from the IMS Health National Disease and Therapeutic Index, a nationally representative audit of ambulatory physicians, were used to examine trends in office visits by children and adolescents (under age 18) during which ADHD was treated with Adderall, other psychostimulants, or atomoxetine. Segmented time series regressions were conducted to determine changes in use associated with three advisories issued between 2005 and 2007. Results In 2004, before the first FDA advisory, Adderall accounted for 36% of ADHD pharmacotherapy treatment visits. Other stimulants accounted for 46%, and atomoxetine accounted for 19%. Overall pharmacotherapy treatment rates were stable over the study period, but by 2008 the treatment visits accounted for by Adderall (that is, market share) declined to 24%, and the market share for atomoxetine declined to 8%. The market share for substitute therapies—clonidine, guanfacine, and bupropion—was stable over this period, ranging from 5% to 7%. Despite the declines in the use of Adderall and atomoxetine over the study period, results from the regression models suggest that the advisories did not have a statistically significant effect on ADHD medication prescribing. Conclusions FDA advisories regarding potential cardiovascular and other risks of ADHD medications had little discernible incremental effect on the use of these medicines in this nationally representative ambulatory audit. PMID:23318985

  15. Editorial Perspective: How should child psychologists and psychiatrists interpret FDA device approval? Caveat emptor.

    PubMed

    Arns, Martijn; Loo, Sandra K; Sterman, M Barry; Heinrich, Hartmut; Kuntsi, Jonna; Asherson, Philip; Banaschewski, Tobias; Brandeis, Daniel

    2016-05-01

    Recently several new tests have received US Federal Drug Administration (FDA) marketing approval as aids in the diagnostic process for attention deficit hyperactivity disorder (ADHD), including the Neuropsychiatric electroencephalogram (EEG)-Based ADHD Assessment Aid (NEBA) Health test. The NEBA test relies upon an EEG-based measure, called the theta to beta ratio (TBR). Although this measure has yielded large differences between ADHD and non-ADHD groups in studies prior to 2009, recent studies and a meta-analysis could not replicate these findings. In this article, we have used the NEBA device as an exemplar for a discussion that distinguishes between FDA de novo marketing approval for a device and any claims that that device is empirically supported, scientifically validated with replicated findings. It is understood that the aims of each differ; however, for many, including the lay public as well as some mental health professionals, these terms may be confused and treated as though they are synonymous. With regard to the TBR measure, there is no reliable association or replication for its clinical usage in the ADHD diagnostic process. The recommendation for potential consumers of the NEBA Health test (as well as perhaps for other existing FDA-approved diagnostic tests) is caveat emptor (let the buyer beware!). PMID:27090383

  16. [Requirements for leading surgeons from the viewpoint of hospital administration authorities].

    PubMed

    Richter, A; Menger, M; Pföhler, W

    2010-08-01

    A private hospital company has the same criteria for leading surgeons as all other healthcare providers. The main criteria are medical competency and good manners with patients and medical staff. Economical knowledge is also very important but does not necessarily include a special qualification in business administration, such as MBA. The head of a surgical department must be able to include current developments in health policy into the work. He should also be able to analyze his own situation and make corrections if possible and discuss the current economical situation in a constructive and trustworthy manner with the management. The head of a surgical department is responsible for the quality of medical and surgical education of his staff. PMID:20628861

  17. 26 CFR 1.860F-4 - REMIC reporting requirements and other administrative rules.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES (CONTINUED) Real Estate Investment Trusts § 1.860F... required by section 6011(a), for each taxable year on Form 1066, U.S. Real Estate Mortgage Investment... assets that are real estate assets defined in section 856(c)(6)(B), computed by reference to the...

  18. 8 CFR 1215.7 - Instructions from the Administrator required in certain cases.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... required in certain cases. 1215.7 Section 1215.7 Aliens and Nationality EXECUTIVE OFFICE FOR IMMIGRATION REVIEW, DEPARTMENT OF JUSTICE IMMIGRATION REGULATIONS CONTROLS OF ALIENS DEPARTING FROM THE UNITED STATES... Immigration and Nationality Act, or in the status of a nonimmigrant under section 11(3), 11(4), or 11(5)...

  19. 75 FR 31273 - Social Security Administration Implementation of OMB Guidance for Drug-Free Workplace Requirements

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-03

    ...The Office of Management and Budget (OMB) is consolidating all Federal regulations concerning drug-free workplace requirements for recipients of financial assistance. Accordingly, we are removing our regulation on this subject currently located within title 20 of the Code of Federal Regulations (CFR) and issuing a new regulation to adopt the OMB guidance at 2 CFR part 182. The new regulation......

  20. 26 CFR 1.7519-2T - Required payments-procedures and administration (temporary).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Negligence and fraud penalties made applicable. For purposes of section 6653, relating to additions to tax for negligence and fraud, any payment required by this section shall be treated as a tax. ... TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES (CONTINUED) The Tax Court § 1.7519-2T...

  1. 26 CFR 1.7519-2T - Required payments-procedures and administration (temporary).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) Negligence and fraud penalties made applicable. For purposes of section 6653, relating to additions to tax for negligence and fraud, any payment required by this section shall be treated as a tax. ... TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES (CONTINUED) The Tax Court § 1.7519-2T...

  2. 26 CFR 1.7519-2T - Required payments-procedures and administration (temporary).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Negligence and fraud penalties made applicable. For purposes of section 6653, relating to additions to tax for negligence and fraud, any payment required by this section shall be treated as a tax. ... TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES (CONTINUED) The Tax Court § 1.7519-2T...

  3. 78 FR 13070 - Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-26

    ...The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators.'' This guidance is intended to assist clinical investigators, industry, and FDA staff in interpreting and complying with the regulations governing financial disclosure by clinical......

  4. 75 FR 29561 - Memorandum of Understanding Between the Food and Drug Administration and Drugs.Com

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-26

    ...The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and Drugs.Com. The purpose of the MOU is to extend the reach of FDA Consumer Health Information and to provide consumers with better information and timely content concerning public health and safety topics, including alerts of emerging safety issues and product...

  5. Similarities and differences in the oncology drug approval process between FDA and European Union with emphasis on in vitro companion diagnostics.

    PubMed

    Senderowicz, Adrian M; Pfaff, Otmar

    2014-03-15

    Drug approval [U.S. Food and Drug Administration (FDA), or market authorization for the European Union's European Medicines Agency (EMA)] is the most significant regulatory milestone for any drug, as drugs can only be marketed after marketing approval by a health authority. This article focuses on the main regulatory aspects of the drug approval process in the European Union (EU) and the United States. Although the procedures, requirements, and timelines for drug approvals are different between the EU and the United States, several global harmonization efforts have been developed during the past few years to have more consistent regulatory procedures/outcomes in different parts of the world. One of the most different procedures/requirements among these regions is co-development, also known as in vitro companion diagnostic. In the United States, it is expected that for a drug that requires an in vitro diagnostic test to select the population to be treated, the companion diagnostic should be already/concomitantly approved by the FDA. In the EU, these requirements are not as stringent as in the United States. However, it is anticipated that in the very near future, legislation changes in the EU will lead to similar requirements for the companion diagnostics for EMA. In summary, although the principles, procedures, and requirements for drug approvals may differ between the United States and EMA, novel efforts to harmonize them are being considered and implemented, thereby leading to simpler global drug development. It is of outmost importance that drug developers understand and appreciate differences in regional regulations. Otherwise, lack of understanding may lead to rejection or delays in drug approvals for useful anticancer agents. See all articles in this CCR Focus section, "The Precision Medicine Conundrum: Approaches to Companion Diagnostic Co-development." PMID:24634467

  6. Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair. Final order.

    PubMed

    2016-01-01

    The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of a premarket approval application (PMA) or notice of completion of a product development protocol (PDP) for surgical mesh for transvaginal pelvic organ prolapse (POP) repair. PMID:26742183

  7. 75 FR 54347 - Draft Guidance for Industry: Bar Code Label Requirements-Questions and Answers (Question 12...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-07

    ... regulations require that certain human drug and biological product labels contain a bar code (Sec. 201.25 (21... Guidance (October 5, 2006, 71 FR 58739). In this guidance, FDA is proposing to amend our response to... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Bar Code Label...

  8. The Dangers of Dental Devices as reported in the FDA MAUDE Database

    PubMed Central

    Hebballi, Nutan B; Ramoni, Rachel; Kalenderian, Elsbeth; Delattre, Veronique F.; Stewart, Denice C.L.; Kent, Karla; White, Joel M; Vaderhobli, Ram; Walji, Muhammad F

    2014-01-01

    Objectives To determine the frequency and type of adverse events (AEs) associated with dental devices reported to Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. Methods We downloaded and thoroughly reviewed the dental device-related AEs reported to MAUDE from January 01, 1996 – December 31, 2011. Results MAUDE received a total of 1,978,056 reports between January 01, 1996 and December 31, 2011. Among these reports, 28,046 (1.4 percent) AEs reports were associated with dental devices. Within the dental AE reports that had event type information, 17,261 reported injuries, 7,777 reported device malfunctions, and 66 reported deaths. Among the 66 entries classified as death reports, 52 actually reported a death in the description; the remaining were either misclassified or lacked sufficient information in the report to determine whether a death had occurred. 53.5 percent of the dental device associated AEs pertained to endosseous implants. Conclusion There is a plethora of devices used in dental care, and to achieve Element 1 of AHRQ’s Patient Safety Initiative, we must be able to monitor the safety of dental devices. While MAUDE is essentially the single source of this valuable information, our investigations led us to conclude that it currently has major limitations that prevent it from being the broad-based patient safety sentinel the profession requires. Practical Implications As potential contributors to MAUDE, dental care teams play a key role in improving the profession’s access to information about the safety of dental devices. PMID:25637208

  9. 24 CFR 570.610 - Uniform administrative requirements and cost principles.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., and requirements of 24 CFR part 85 and OMB Circulars A-87, A-110 (implemented at 24 CFR part 84), A-122, A-133 (implemented at 24 CFR part 45), and A-128 2 (implemented at 24 CFR part 44), as applicable... 24 CFR parts 84 and 85 are set forth at § 570.502. 2 See footnote 1 at § 570.200(a)(5)....

  10. 24 CFR 570.610 - Uniform administrative requirements and cost principles.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., and requirements of 24 CFR part 85 and OMB Circulars A-87, A-110 (implemented at 24 CFR part 84), A-122, A-133 (implemented at 24 CFR part 45), and A-128 2 (implemented at 24 CFR part 44), as applicable... 24 CFR parts 84 and 85 are set forth at § 570.502. 2 See footnote 1 at § 570.200(a)(5)....

  11. Information requirements of the National Aeronautics and Space Administration's safety, environmental health, and occupational medicine programs

    NASA Technical Reports Server (NTRS)

    Whyte, A. A.

    1978-01-01

    A survey of the internal and external reporting and recordkeeping procedures of these programs was conducted and the major problems associated with them are outlined. The impact of probable future requirements on existing information systems is evaluated. This report also presents the benefits of combining the safety and health information systems into one computerized system and recommendations for the development and scope of that system.

  12. Telavancin for Acute Bacterial Skin and Skin Structure Infections, a Post Hoc Analysis of the Phase 3 ATLAS Trials in Light of the 2013 FDA Guidance

    PubMed Central

    Pushkin, Richard; Barriere, Steven L.; Corey, G. Ralph; Stryjewski, Martin E.

    2015-01-01

    Two phase 3 ATLAS trials demonstrated noninferiority of telavancin compared with vancomycin for complicated skin and skin structure infections. Data from these trials were retrospectively evaluated according to 2013 U.S. Food and Drug Administration (FDA) guidance on acute bacterial skin and skin structure infections. This post hoc analysis included patients with lesion sizes of ≥75 cm2 and excluded patients with ulcers or burns (updated all-treated population; n = 1,127). Updated day 3 (early) clinical response was defined as a ≥20% reduction in lesion size from baseline and no rescue antibiotic. Updated test-of-cure (TOC) clinical response was defined as a ≥90% reduction in lesion size, no increase in lesion size since day 3, and no requirement for additional antibiotics or significant surgical procedures. Day 3 (early) clinical responses were achieved in 62.6% and 61.0% of patients receiving telavancin and vancomycin, respectively (difference, 1.7%, with a 95% confidence interval [CI] of −4.0% to 7.4%). Updated TOC visit cure rates were similar for telavancin (68.0%) and vancomycin (63.3%), with a difference of 4.8% (95% CI, −0.7% to 10.3%). Adopting current FDA guidance, this analysis corroborates previous noninferiority findings of the ATLAS trials of telavancin compared with vancomycin. PMID:26248356

  13. Support of NASA quality requirements by defense contract administration services regions

    NASA Technical Reports Server (NTRS)

    Farrar, Hiram D.

    1966-01-01

    Defense Contract Administration Services Regions (DCASR) quality assurance personnel performing under NASA Letters of Delegation must work closely with the assigned technical representative of the NASA centers. It is realized that technical personnel from the NASA Centers cannot make on-site visits as frequently as they would like to. However, DCASR quality assurance personnel would know the assigned NASA technical representative and should contact him when problems arise. The technical representative is the expert on the hardware and should be consulted on any problem area. It is important that the DCASR quality assurance personnel recommend to the delegating NASA Center any new or improved methods of which they may be aware which would assist in achieving the desired quality and reliability in NASA hardware. NASA expects assignment of competent personnel in the Quality Assurance functional area and is not only buying the individual's technical skill, but also his experience. Suggestions by field personnel can many times up-grade the quality or the hardware.

  14. FDA advisory committees meet January 26 on Salk HIV-1 immunogen.

    PubMed

    1995-01-01

    Two advisory committees of the Food and Drug Administration (FDA) will meet to consider future trials of the HIV-1 immunogen developed by Dr. Jonas Salk. The Immune Response Corporation has already conducted several studies of the immunogen, and has found improvement in various immunological and other blood tests, and no adverse effects. However, the studies have not been large enough to show conclusively that the treatment has clinical benefit in delaying disease progression. The new, larger trials are intended to demonstrate a delay in disease progression and validate the use of blood-test markers of disease progression for studying an immune-based treatment. PMID:11362184

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

    Cancer.gov

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

  16. 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. PMID:26372890

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

    Cancer.gov

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

  18. 20 CFR 652.210 - What are the Act's requirements for administration of the work test and assistance to UI claimants?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... administration of the work test and assistance to UI claimants? 652.210 Section 652.210 Employees' Benefits... requirements for administration of the work test and assistance to UI claimants? (a) State UI law or rules establish the requirements under which UI claimants must register and search for work in order to...

  19. 20 CFR 652.210 - What are the Act's requirements for administration of the work test and assistance to UI claimants?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... appropriate to facilitate their earliest return to work; (2) UI claimants requiring assistance in seeking work... administration of the work test and assistance to UI claimants? 652.210 Section 652.210 Employees' Benefits... requirements for administration of the work test and assistance to UI claimants? (a) State UI law or...

  20. National Aeronautics and Space Administration Manned Spacecraft Center data base requirements study

    NASA Technical Reports Server (NTRS)

    1971-01-01

    A study was conducted to evaluate the types of data that the Manned Spacecraft Center (MSC) should automate in order to make available essential management and technical information to support MSC's various functions and missions. In addition, the software and hardware capabilities to best handle the storage and retrieval of this data were analyzed. Based on the results of this study, recommendations are presented for a unified data base that provides a cost effective solution to MSC's data automation requirements. The recommendations are projected through a time frame that includes the earth orbit space station.