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Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309048370
Category : Medical
Languages : en
Pages : 239
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Book Description
Like many other agencies of the federal government, the Food and Drug Administration (FDA) relies extensively on external advisory committees for independent scientific and technical advice. Recognizing that the existing advisory committee system is essentially sound, this volume recommends ways of enhancing the use of these committees in the evaluation of drugs, biological materials, and medical devices; strengthening the agency's management of the system; and increasing the accountability of the system to the public. In doing so, it examines and makes recommendations on such issues as the recruitment of committee members, the FDA's management of financial conflict of interest and intellectual bias among members, and the operations and management of the advisory committee system.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309048370
Category : Medical
Languages : en
Pages : 239
Get Book Here
Book Description
Like many other agencies of the federal government, the Food and Drug Administration (FDA) relies extensively on external advisory committees for independent scientific and technical advice. Recognizing that the existing advisory committee system is essentially sound, this volume recommends ways of enhancing the use of these committees in the evaluation of drugs, biological materials, and medical devices; strengthening the agency's management of the system; and increasing the accountability of the system to the public. In doing so, it examines and makes recommendations on such issues as the recruitment of committee members, the FDA's management of financial conflict of interest and intellectual bias among members, and the operations and management of the advisory committee system.
Author:
Publisher: DIANE Publishing
ISBN: 1437911315
Category :
Languages : en
Pages : 67
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Book Description
Author: Michael Dolan
Publisher:
ISBN: 9780914176800
Category : Drugs
Languages : en
Pages :
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Book Description
Author: United States. Congress. House. Committee on Government Operations
Publisher:
ISBN:
Category : Citizens' advisory committees in science
Languages : en
Pages : 570
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Book Description
Author: Aaron A. Love
Publisher:
ISBN:
Category :
Languages : en
Pages : 0
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Book Description
This paper focuses on the central role that advisory committees play in FDA's regulation of new and existing drugs. Part I of the paper reviews the 'ideal' role of advisory committees: the authority for creating advisory panels, how they are regulated, what part they were designed to play, and the agency's legitimate statutory and regulatory powers to 'shape' expert panels. Part II explores problems with the system, including the problem of conflicts of interest, of “packaging science,” and the susceptibility of committees to gamesmanship by interests seeking the legitimation benefits of scientific consensus. Part III categorizes and describes the various ways the ideal system breaks down, illustrated with recent examples of each in the context of drugs and devices. How is the process susceptible to forms of manipulation that undermine the quality of committee decisions? For example, the decision whether to convene an advisory committee meeting, through the selective presentation of evidence, by requesting re-hearings on issues when the committee makeup changes? Under what circumstances has the agency chosen to depart from committee recommendations? Part IV asks what this means for courts reviewing agency decisions when these warning signs are present, or when FDA simply disagrees with a committee decision. Ultimately, plaintiffs have not been successful in challenging agency regulatory decisions despite suspicious advisory committee procedures, although the courts are willing to override FDA in cases of egregious interference. Finally, Part V briefly describes how changes to the advisory committee process could improve the quality of agency decision-making, and how cracking down on some of these practices may paradoxically undermine the effectiveness of the program in other respects. For instance, adopting stringent conflict standards inevitably shrinks the pool of suitable experts.
Author: United States. Congress. House. Committee on Government Operations. Intergovernmental Relations Subcommittee
Publisher:
ISBN:
Category : Citizens' advisory committees in science
Languages : en
Pages : 672
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Book Description
Author:
Publisher:
ISBN:
Category : Citizens' advisory committees
Languages : en
Pages : 6
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Book Description
Author: United States. Congress. House. Committee on Government Operations. Intergovernmental Relations Subcommittee
Publisher:
ISBN:
Category : Public health administration
Languages : en
Pages : 396
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Book Description
Author: Michael Dolan
Publisher:
ISBN: 9780914176794
Category : Drugs
Languages : en
Pages :
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Book Description
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages :
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Book Description
The Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) presents information on human drug advisory committees. These committees offer independent opinions and recommendations to the FDA related to new drugs and FDA policies. CDER includes meeting transcripts, a list of the advisory committee staff, a calendar of events, and information on other FDA advisory committees.
