May 10 FDA Advisory Committee Meeting: Truvada for Pre-Exposure Prophylaxis (PrEP)March 16, 2012 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 HIV1 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: 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. FDA is opening a docket for public comment on this meeting. The docket number is FDA2012N0218, 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 www.regulations.gov. Submit written comments to: Please identify comments with the docket number FDA2012N0218. 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 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 www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Complete Federal Register Notice ![]()
Add Your Comment:
(Please note: Your name and comment will be public, and may even show up in
Internet search results. Be careful when providing personal information! Before adding your comment, please read TheBody.com's Comment Policy.) |