Tuesday, December 9, 2008

HIV/AIDS Update - FDA Obstetrics and Gynecology Devices Panel meeting to consider FC2 Female Condom

You are receiving this message as a subscriber to the FDA HIV/AIDS electronic list serve. The purpose of the list serve is to relay important information about HIV/AIDS-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.

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On Dec 11, 2008, FDA's Obstetrics and Gynecology Devices Panel will meet from 8:00 AM - 5:30 PM at the Gaithersburg Holiday Inn, Walker/Whetstone Salons Two Montgomery Village Ave.,in Gaithersburg, MD.  (301.948.8900)

The committee will discuss, make recommendations, and vote on a premarket approval application for the FC2 Female Condom, sponsored by the Female Health Company. This device is indicated to help prevent HIV/AIDS and unintended pregnancy. The following background material are available to the public on the FDA web site:

Draft Agenda

Briefing Information

Proposed Questions

Draft Roster

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams, Conference Management Staff, at 240-276-8932, in advance of the meeting.

Up-to-date information on this meeting is available through the FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512524.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

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