FDA Hearing on Truvada for PrEP Set for May 10

The Food and Drug Administration (FDA) has announced an upcoming meeting of its Antiviral Drugs Advisory Committee on May 10, from 8 a.m. to 5:30 p.m. (EST) The meeting will be held at the FDA White Oak Campus in Silver Spring, Maryland.

The committee will discuss an efficacy supplement for Truvada (emtricitabine/tenofovir) submitted by Gilead Sciences, Inc. The supplemental application proposes an indication for Pre-Exposure Prophylaxis (PrEP) to reduce the risk of sexually acquired HIV–1 infection.

Data, information, or views can be presented by individuals orally at the meeting, or in writing. Anyone interested in making formal oral presentations should notify Yvette Waples at (301) 796-9001, FAX: (301) 847-8533, or email AVAC@fda.hhs.gov. Submission of a brief statement of the general nature of the evidence or arguments to be presented, the names and addresses of proposed participants, and an indication of the approximate time requested to make the presentation must be made on or before April 18. People making submissions will be notified by April 19 regarding their request to speak.

The docket number for public comment is FDA–2012–N–0218, which opened on March 14 and will close on May 17. Either electronic or written comments regarding this meeting may be submitted. Submit electronic comments at: http://www.regulations.gov/?source=govdelivery#!home.

Submit written comments to:
Division of Dockets Management (HFA–305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852.

Please identify comments with the docket number. Be aware that comments received will be posted without change, including any personal information provided. All electronic and written comments submitted to the Docket on or before April 26 will be provided to the committee.

For up-to-date information on this meeting, please call the FDA Advisory Committee Information Line, (800) 741-8138, (301) 443-0572 in the Washington, DC area. You should always check the FDA website for any changes and/or call the appropriate advisory committee hotline/phone line to learn about possible modifications before coming to the meeting.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.

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