ROCKVILLE, Md., April 18, 2007--Due to water damage caused by flooding over the weekend, FDA has been forced to change the location for the upcoming Antiviral Drugs Advisory Committee meeting on April 24, 2007 to discuss new drug application for maraviroc 300 milligram tablets. Originally scheduled to be held at the FDA, Center for Drug Evaluation and Research Advisory Committee Conference Room, Room, 5630 Fishers Lane, in Rockville, MD, the meeting has been relocated to
Crown Plaza Hotel Silver Spring Kennedy Ballroom 8777 Georgia Avenue, Silver Spring, MD 20910.
If you need to arrange accommodations or get directions, you can contact the hotel directly at 301-589-0800. A map and local area information is available at the Silver Spring Downtown <http://www.silverspringdowntown.com/spring.php?pid=345> web site.
The committee will discuss new drug application (NDA) 022-128, maraviroc 300 milligram tablets, Pfizer, Inc., proposed for the treatment of antiretroviral-experienced patients with chemokine (c-c motif) receptor 5 (CCR5)--tropic human immunodeficiency virus (HIV).
Background material for this meeting will be available to the public no later than 1 business day before the meeting. Posted background material is available at http://www.fda.gov/ohrms/dockets/ac/cder07.htm#AntiviralDrugs <http://www.fda.gov/ohrms/dockets/ac/cder07.htm> . The Change in Meeting Location notice, and Federal Register Notice announcing the change will also be posted at this site.
The meeting is open to the public. There is no registration required, and no fees associated with attending FDA advisory committee meetings. However, please be sure to have a photo ID to enter this government building.
Contact Person: Cicely Reese, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: firstname.lastname@example.org email@example.com>
Please call the FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512531 for further, up-to-date information about this meeting.
Persons 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 Cicely Reese 7 days in advance of the meeting.
Richard Klein Office of Special Health Issues Food and Drug Administration
Kimberly Struble Division of Antiviral Products Food and Drug Administration
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FDA web site at http://www.fda.gov/oashi/aids/listserve/archive.html
1-888-INFO-FDA (1-888-463-6332) -- main FDA Phone Number (for general inquiries)