May 11, 2012 FDA advisory committee meeting: fixed-dose combination tablet of elvitegravir/cobicistat/emtricitabine/ tenofovir disoproxil fumarate
FDA is announcing an upcoming meeting of its Antiviral Drugs Advisory Committee on May 11, 2012, from 8 a.m. to 500 p.m.. The committee will discuss a new drug application (NDA) for a fixed-dose combination tablet of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate, submitted by Gilead Sciences, Inc. The application proposes an indication for the treatment of HIV–1 infection in adults who are antiretroviral naive or have no known substitutions associated with resistance to the individual components.
The meeting will be held at the DoubleTree by Hilton Hotel Washington DC/Silver Spring, The Ballrooms, 8727 Colesville Rd., Silver Spring, MD. The hotel telephone number is 301–589–5200. The hotel is near the Red Line Silver Spring metro station.
The meeting is open to the public. No registration is required.
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 1 p.m. and 2 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 19, 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 20, 2012.
Written submissions may be made to Yvette Waples using the contact information above, on or before April 27, 2012.
Please call the Information Line at 1–800– 741–8138 (301–443–0572 in the Washington, DC area), and follow the prompts to the desired center or product area for up-to-date information on this meeting, or check the Advisory Committee web site to check for possible last-minute schedule changes.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/ucm295937.htm.
Those attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
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 Yvette Waples at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/ AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.
Complete Federal Register Notice.
Office of Special Health Issues
Food and Drug Administration
Division of Antiviral Drug Products
Food and Drug Administration