Webcasts for FDA Transparency Task Force to Public Meetings available

As already written in one of our previous Newsletters (please see News from 10 June 2009), the U.S. Food and Drug Administration (FDA) has formed an internal Transparency 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 public will have an opportunity to provide comments to the task force about how FDA should explain what the agency is doing, the basis for the agency's decisions, and the processes used to make agency decisions.

The Task Force will take the following actions:

  • Seek public input on issues related to transparency;
  • Recommend ways that the agency can better explain its operations, activities, processes, and decision making, compatible with the agency's goal of appropriately protecting confidential information;
  • Identify information FDA should provide about specific agency operations, activities, processes, and decision making, including enforcement actions, recalls, 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, taking into consideration health literacy and the needs of special populations;
  • Identify appropriate tools and new technologies for informing the public;
  • Recommend changes to FDA's current operations (e.g., internal policies and procedures, standards, information formats, and guidance) to improve the agency's ability to provide such information to the public in a timely and effective manner;
  • Recommend legislative or regulatory changes, if appropriate, to improve FDA's ability to provide such information to the public; and
  • Submit a written report to the Commissioner on the Task Force's findings and recommendations.

Public Meetings:
Anyone may attend the respective public meetings at no cost. The first public meeting was held June 24, 2009 in Washington, D.C. A webcast of this meeting is available here.

The second public meeting will be held 3 November 2009. The meeting will also be held in Washington, D.C.

The purpose of the meeting is to receive detailed comments on three specific issues related to transparency at the FDA:

  • Early communication about emerging safety issues concerning FDA-regulated products
  • Disclosure of information about product applications that are abandoned, i.e., no work is being done or will be undertaken to have the application approved, or withdrawn by the applicant before approval
  • Communication of agency decisions about pending product applications.

Those who cannot attend the meeting can view it via live Webcast. The Webcast will be archived and available for viewing on the FDA website.

Source: FDA Transparency Task Force Homepage

Compiled by
Wolfgang Schmitt
On the behalf of the European Compliance Academy (ECA)

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