FDA Antiviral Drug Advisory Committee Will Meet in May to Discuss New Indication for TRUVADA

The Food and Drug Administration (FDA) announces the upcoming meeting of its Antiviral Drugs Advisory Committee on May 10, 2012, from 8 a.m. to 5:30 p.m.  The committee will discuss an efficacy supplement for TRUVADA (emtricitabine/tenofovir disoproxil fumarate) Tablet, 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.

The meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993.  Information regarding special accommodations for a disability, visitor parking, transportation, and lodging may be accessed at: http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘Public Meetings at the FDA White Oak Campus.’’  Please note that visitors to the White Oak Campus must enter through Building 1.

The meeting is open to the public.  No registration is required.  Free parking will be available.

Interested persons
may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee. Oral presentations from the public will be scheduled between approximately 2 p.m. and 3 p.m. Those individuals interested in making formal oral presentations should notify Yvette Waples, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993–0002, 301.796.9001, FAX: 301.847.8533, or email: AVAC@fda.hhs.gov, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 18, 2012. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. Interested persons will be notified regarding their request to speak by April 19, 2012.

Click here for more information about public participation in the upcoming meeting and how to obtain additional information as it becomes available.