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GUIDANCE DOCUMENT

Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees Draft Guidance for the Public, FDA Advisory Committee Members, and FDA Staff June 2016

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2016-D-1399
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition
Center for Tobacco Products
Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research
Office of the Commissioner, Office of the Chief Scientist, National Center for Toxicological Research

Advisory committees provide independent, expert advice to FDA on a range of issues affecting the public health. To protect the credibility and integrity of advisory committee advice, FDA screens advisory committee members carefully for two categories of potentially disqualifying interests or relationships:

  1. current financial interests that may create a recusal obligation under Federalconflict of interest laws; and
  2. other interests and relationships that do not create a recusal obligation under Federal conflict of interest laws but that may create the appearance that a member lacks impartiality, known as "appearance issues."   

In August 2008, FDA issued a guidance describing the process it uses to decide whether an advisory committee member has potentially disqualifying interests in the first category, i.e., current financial conflicts of interest that may create a recusal obligation under Federal conflict of interest laws. The 2008 guidance also describes FDA’s process for determining whether to grant a waiver for an advisory committee member with a financial conflict of interest to participate in an advisory committee meeting.

This draft guidance addresses FDA’s process for evaluating whether an advisory committee member has potentially disqualifying interests or relationships that fall into the second category of interests: appearance issues.  It also describes FDA’s process for determining whether to authorize a member with an appearance issue to participate in the advisory committee meeting.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-1399.

 
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