FDA Transparency Task Force

On June 2, 2009, the Food and Drug Administration (FDA) announced the formation of a task force to develop recommendations for enhancing the transparency of the FDA’s operations and decision-making process. The task force, which will be chaired by Principal Deputy Commissioner Joshua Sharfstein, M.D., will:

  • Seek public input on issues related to transparency;
  • Recommend ways that the agency can better explain its operations compatible with the appropriate protection of confidential information;
  • Identify information the FDA should provide about specific agency operations and activities, including enforcement actions and product approvals;
  • Identify problems and barriers, both internal and external, to providing useful and understandable information about FDA activities and decision-making to the public;
  • Identify appropriate tools and new technologies for informing the public;
  • Recommend changes to the FDA’s current operations, including internal policies and guidance, to improve the agency’s ability to provide information to the public in a timely and effective manner;
  • Recommend legislative or regulatory changes, if appropriate, to improve the FDA’s ability to provide information to the public; and
  • Submit a written report to the commissioner on the Transparency Task Force’s findings and recommendations.

To further these efforts, the FDA is holding a meeting June 24, 2009 to solicit recommendations on how the agency can improve the way it provides information about FDA activities to the public.

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Life Sciences Legal Update - June 9, 2009 10:10 AM
The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following: - FDA Transparency Task Force - Toll-Free Numbers for Adverse Events Reporting - Generic Drugs
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