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U.S. Department of Health and Human Services

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FDA Transparency Task Force

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Overview

The Food and Drug Administration (FDA) has formed a task force to develop recommendations for making useful and understandable information about FDA activities and decision making more readily available to the public in a timely manner and in a user-friendly format.

The Task Force is seeking public opinion on how to make the agency’s information on activities and decision making more transparent, useful, and understandable to the public, while appropriately protecting confidential information.

Phase I: FDA Basics

The FDA has created a Web-based resource called “FDA Basics,” aimed at helping the public better understand what the agency does. Key elements of FDA Basics are: 

  • Questions and answers about the agency and the products it regulates 
  • Short videos that explain various agency activities 
  • Conversations with agency personnel about the work of their office

Update letter on Phase I of the Transparency Initiative

FDA Unveils First Phase of Transparency Initiative (FDA Press Release)

Phase II: Public Disclosure

The Transparency Task Force has released a report containing 21 draft proposals for public comment on public disclosure policies aimed at helping consumers, stakeholders, and others understand how the agency operates and makes decisions, while maintaining confidentiality of trade secrets and individually identifiable patient information. The Task Force will review the comments and decide which proposals to recommend to Commissioner Hamburg for implementation. FDA solicited input from the public on the content of the draft proposals, as well as on which proposals should be given priority, from May 19, 2010 through July 20, 2010.

Phase III: Transparency to Regulated Industry

FDA solicited public input on ways in which FDA can increase transparency between FDA and regulated industry. The Task Force held three listening sessions with members of regulated industry and transcripts and summaries of those listening sessions are below. The Task Force is seeking comment related to issues raised in those sessions or other suggestions related to FDA's transparency to regulated industry.

November 3, 2009 Public Meeting on Transparency

FDA is holding a second public meeting on Tuesday, November 3, 2009 to receive detailed and in-depth comments on three specific issues related to transparency at FDA. The topics to be covered are: (1) early communication about emerging safety issues concerning FDA-regulated products, (2) disclosure of information about product applications that are abandoned (which means that no work is being done or will be undertaken to have the application approved) or withdrawn by the applicant before approval, and (3) communication of agency decisions about pending product applications.

June 24, 2009, Public Meeting on Transparency

FDA held a public meeting on Wed., June 24, 2009, to solicit input from interested persons on ways for the agency to make useful and understandable information about FDA activities and decision making more readily available to the public in a timely manner and in a user-friendly format. 

FDA Transparency Blog 

Provides opportunities to learn and provide feedback on what FDA is doing, the basis for FDA's decisions, and the processes used to make agency decisions. 

Task Force Information 

 

 
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