FDA Transparency Task Force

Topics on this Page: 

• Overview
• Phase I: FDA Basics
• November 3, 2009 Public Meeting on Transparency
• June 24, 2009, Public Meeting on Transparency
• FDA Transparency Blog
• Task Force Information

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)

 

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that are abandoned (which means that no work is being done or will be undertaken to have the application approved) or withdrawn by the applicant before approval, and (3) communication of agency decisions about pending product applications.

• Meeting Transcript (PDF, 628 KB)
• 2nd Meeting of the FDA Transparency Task Force Webcast (Archive)
• Hypothetical Case Studies for November 3 Public Meeting on Transparency
• Agenda

 

 

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. 

• Meeting Agenda
• View Meeting Webcast (Archived)

 

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. 

• FDA Transparency Blog
• Current Issue: Launch of FDA Basics

 

Task Force Information 

• Press Release: FDA Forms Transparency Task Force
• Task Force Mission
• Federal Register Notice: November 3, 2009 meeting
• Federal Register Notice: June 24, 2009 meeting
• Questions and Answers for Consumers