Transparency task force to mull announcements of NDAs
This article was originally published in The Tan Sheet
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about emerging safety issues concerning FDA-regulated products," disclosure of information about abandoned or withdrawn product applications and communication of agency decisions about pending product applications.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)
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FDA accepts comments on its transparency initiative through Nov. 6, after which the Transparency Task Force will conduct its second public meeting. The agency's transparency Web site, which features a blog about the initiative, will operate while the comment docket is open. The task force consists of Principal Deputy Commissioner Josh Sharfstein, the directors of each of FDA's centers, acting Associate Commissioner for Regulatory Affairs Michael Chappell, acting Chief Counsel Michael Landa and acting Chief Scientist Jesse Goodman. Commissioner Margaret Hamburg appointed the task force to identify how to improve communication and better explain agency decisions (1"The Tan Sheet" June 8, 2009)
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