FDA Transparency Task Force to Hold 2nd Public Meeting on Ensuring That Agency Information is Useful, Understandable, Accessible

FDA Transparency Task Force to Hold 2nd Public Meeting on Ensuring That Agency
Information is Useful, Understandable, Accessible

FDA NOTE TO CORRESPONDENTS

SILVER SPRING, Md., Nov. 2 /PRNewswire-USNewswire/ -- The U.S. Food and Drug
Administration will seek comments on three specific issues related to
transparency at the agency during a daylong public meeting on Tuesday, Nov. 3,
2009.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

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. Directions to the NTSB Conference Center are at
http://www.ntsb.gov/events/newlocation.htm

The purpose of the meeting is to receive detailed comments on the following
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application approved, or withdrawn by the applicant before approval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 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.

Those interested can submit electronic or written comments by Nov. 6, 2009.
Submit electronic comments to http://www.regulations.gov. Submit written
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

There is no fee to register for the public meeting. Registration on the day of
the meeting will be permitted on a space-available basis, beginning at 7:30
a.m. Those who cannot attend the meeting can view it via live Webcast at
http://www.capitolconnection.net/capcon/fda/110309/FDAlive.htm

The Webcast will be archived on the FDA Transparency Task Force page
http://www.fda.gov/AboutFDA/WhatWeDo/FDATransparencyTaskForce/default.htm

A media room with dial-up Internet access will be provided. Please note there
is no wireless service within the NTSB Conference Center.

For more information
Hypothetical Case Studies for November 3 Public Meeting on Transparency
http://www.fda.gov/AboutFDA/WhatWeDo/FDATransparencyTaskForce/ucm187750.htm

November 3 Public Meeting on Transparency
http://www.fda.gov/AboutFDA/WhatWeDo/FDATransparencyTaskForce/ucm188633.htm

Media Inquiries: Raymond Formanek Jr., 301-796-4677;
raymond.formanek@fda.hhs.gov
Other Inquiries: Afia Asamoah, 301-796-4625; afia.asamoah@fda.hhs.gov

SOURCE U.S. Food and Drug Administration

Raymond Formanek Jr. of the FDA, +1-301-796-4677,
raymond.formanek@fda.hhs.gov