US FDA's Transparency Task Force to meet in November

The US Food and Drug Administration issued a notice in the Federal Register announcing its Transparency Task Force is holding a public meeting November 3 at the National Transportation Safety Board Conference Center in Washington DC.

The purpose of the meeting is for the task force to receive input on the following three topics: 1) emerging safety issues concerning FDA-regulated products, 2) product applications that are abandoned or withdrawn by the applicant prior to approval, and 3) agency decisions regarding pending product applications.

According to the agency, the November 3 public meeting will be conducted as a series of three moderated discussion groups covering each of the three topics. The topics for each discussion group will be presented in the form of a case study. At the conclusion of each session, task force members will pose questions to the discussion group participants. There also will be a public comment period following each discussion group.

The FDA plans to provide the initial scenarios of the case studies for the three topics in the public docket at least seven days prior to the meeting. Individuals who wish to register for the meeting or to participate in one of the three planned discussion groups must e-mail their information to Transparency.Meeting@fda.hhs.gov by October 27.