Weigh in on Transparency at the FDA

October 20, 2009
Category: Uncategorized

Seize the opportunity to share your suggestions on how the FDA can improve its currently opaque “transparency policy.“ A second public meeting will be held November 3, 2009, from 9 a.m. to 3 p.m. in the National Transportation Safety Board Conference Center at 429 L’Enfant Plaza, SW, Washington, DC (https://secure3.convio.net/aahf/site/Advocacy?cmd=display&page=UserAction&id=431). The three discussion groups are:

(1) Emerging safety issues concerning FDA-regulated products.  What principles should the FDA employ in deciding whether to issue an early alert about a potential problem with an FDA-regulated product?
(2) Product applications abandoned or withdrawn by the applicant before approval.  What guidelines should the FDA follow regarding disclosure of data contained in abandoned or withdrawn product applications?
(3) Communicating agency decisions about pending product applications.  What information regarding pending product applications should be disclosed?
If interested in attending, you must register by October 27, 2009 (transparency.meeting@fda.hhs.gov).  You may also submit electronic or written comments by November 6, 2009.  To post electronic comments, please use the Web form at the link above; to submit written comments, please address the Division of Dockets Management (HFA-305), Food & Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD  20852.
ANH-USA will attend the meeting, actively participate in one of the discussion panels and provide written comments for the remaining two panels. To view the full Public Hearing Notice, click here.  As always, thank you for being involved!

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