MAY 10TH
NOTE: The time, agenda and public participation information has been updated for this meeting.
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 6:30 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. The Center for Drug Evaluation and Research (CDER) also plans to provide a free of charge, live webcast of this meeting. Click here for additional updated information about public participation in the upcoming meeting and how to obtain additional information as it becomes available.
MAY 11TH
A new drug application (NDA) 203-100, for a fixed dose combination tablet of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate, will be the topic of the May 11th meeting. The application proposes an indication for the treatment of HIV-1 infection in adults who are antiretroviral naïve or have no known substitutions associated with resistance to the individual components.
This meeting is also open to the public, and interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee. The meeting will take place at The Ballrooms of the Doubletree Hotel, located at 8727 Colesville Road in Silver Spring, MD. CDER will not be providing a webcast for this meeting. For more information, click here.
