sábado, 17 de marzo de 2012

HIV/AIDS Update - May 10 FDA advisory committee meeting: Truvada for Pre-Exposure Prophylaxis (PrEP)

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FDA is announcing an 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.
FDA is opening a docket for public comment on this meeting. The docket number is FDA–2012–N–0218, which will open for public comment on March 14, 2012, and will close on May 17, 2012. Interested persons may submit either electronic or written comments regarding this meeting. Submit electronic comments to http://www.regulations.gov.
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 FDA–2012–N–0218. Be aware that comments received will be posted without change, including any personal information provided. It is only necessary to send one set of comments. All electronic and written comments submitted to the Docket on or before April 26, 2012 will be provided to the committee.
For up-to-date information on this meeting, please call the FDA Advisory Committee Information Line, 1.800.741.8138 (301.443.0572 in the Washington, DC area), and follow the prompts to the desired center or product area.. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.
FDA intends to make background materials available to the public on its web site no later than 2 business days before the meeting. If FDA is unable to post the background material 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 will be available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the Antiviral Drugs Advisory Committee link.
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
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

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