The end time for the May 10, 2012 Antiviral Drugs Advisory Committee (AVDAC) meeting has been extended to 6:30 p.m. The Agenda portion regarding the new drug application (NDA) 21-572, TRUVADA (emtricitabine/tenofovir disoproxil fumarate) Tablet, submitted by Gilead Sciences, Inc. should read "new drug application (NDA) 21-752." The Procedure portion is changed to a two hour open public hearing from approximately 1:45 p.m. to 3:45 p.m. The deadline for submitting comments to the docket has been extended such that comments received on or before May 3, 2012, will be provided to the committee before the meeting. There are no other changes.
The time should be updated to read: "8:00 a.m. to 6:30 p.m."
The agenda should be updated to read as follows: "On May 10, 2012, the committee will discuss an efficacy supplement for new drug application (NDA) 21-752, 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."
Public Participation Information:
The sentence "Oral presentations from the public will be scheduled between approximately 2 p.m. to 3 p.m." should be updated to read "Oral presentations from the public will be scheduled between approximately 1:45 p.m. to 3:45 p.m." The sentence “Comments received on or before April 26, 2012, will be provided to the committee before the meeting” should be updated to read “Comments received on or before May 3, 2012, will be provided to the committee before the meeting.
|CDER||May 10, 2012||8:00 a.m. to 5:30 p.m.|
FDA White Oak Campus
The Great Room (Room 1503)
On May 10, 2012, the committee will discuss an efficacy supplement for new drug application (NDA) 21-572, 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.
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.
Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
- FDA is opening a docket for public comment on this meeting. The docket number is FDA-2012-N-0218. The docket will open for public comment on March 14, 2012. The docket 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 the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments received will be posted without change, including any personal information provided. It is only necessary to send one set of comments. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Comments received on or before April 26, 2012, will be provided to the committee before the meeting.
- Oral presentations from the public will be scheduled between approximately 2 p.m. to 3 p.m. on May 10, 2012. Those desiring to make formal oral presentations should notify the contact person 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. The contact person will notify interested persons regarding their request to speak by April 19, 2012.
CDER plans to provide a free of charge, live webcast of the May 10, 2012, meeting of the Antiviral Drugs Advisory Committee. While CDER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: 2012 Meeting Materials, Antiviral Drugs Advisory Committee CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.
- Yvette Waples, Pharm.D.
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
- FDA Advisory Committee Information Line
1-800-741-8138 (301-443-0572 in the Washington DC area)
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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 FDA Advisory Committee Information Line to learn about possible modifications before coming to the meeting.
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Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).