FDA holds meeting on issues related to transparency at the agency

FDA Transparency Task Force to Hold 2nd Public Meeting on Ensuring That Agency Information is Useful, Understandable, Accessible

The U.S. Food and Drug Administration will seek comments on three specific issues related to transparency at the agency during a daylong public meeting on Tuesday, Nov. 3, 2009.

The meeting is scheduled for 9 a.m. to 3 p.m. at the National Transportation Safety Board Conference Center, 429 L'Enfant Plaza, S.W., Washington, D.C., 20594. Directions to the NTSB Conference Center are at http://www.ntsb.gov/events/newlocation.htm

The purpose of the meeting is to receive detailed comments on the following 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applications that are abandoned, i.e., no work is being done or will be undertaken to have the application approved, or withdrawn by the applicant before approval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.

The FDA formed an internal Transparency Task Force in response to the Obama Administration's commitment to achieve "an unprecedented level of openness in Government." The Task Force is developing recommendations for making useful and understandable information about FDA activities and decision-making more readily available in a timely manner and in a user-friendly format, while appropriately protecting confidential information.

The task force held its first daylong meeting in June 2009.