The FDA will seek comments on how to ensure that information on FDA activities and decision-making is useful, understandable, and accessible to the public, during a daylong public meeting on 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. 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applications that are abandoned, i.e., no work is being done or will be undertaken to have the application approved, or withdrawn by the applicant before approval Communication of agency decisions about pending product applications. 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 to the public 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.
