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          Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory CommitteesSearch for FDA Guidance Documents 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			Draft Guidance for the Public, FDA Advisory Committee Members, and FDA Staff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	Download the  Draft  Guidance Document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	  	    Not for implementation.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.
	  
	  
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    PrintDocket 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:

current financial interests that may create a recusal obligation under Federalconflict of interest laws; and
	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This draft guidance addresses FDA’s process for evaluating whether an advisory committee member has potentially disqualifying interests or relationships that fall into the second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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						All written comments should be identified with this document's docket number: FDA-2016-D-1399.

                                                                                  Content current as of:
      06/29/2016
         
                  
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