Transparency task force to mull announcements of NDAs
This article was originally published in The Tan Sheet
Executive Summary
FDA will ask whether the public should be informed when sponsors file applications for drugs and other products, at a second public Transparency Task Force meeting Nov. 3 in Washington to discuss the communication issues. Topics include "early communication about emerging safety issues concerning FDA-regulated products," disclosure of information about abandoned or withdrawn product applications and communication of agency decisions about pending product applications. Attendees must register by 5 p.m. on Oct. 27, and comments must be submitted electronically by Nov. 6 (1"The Tan Sheet" Sept. 14, 2009)