Important note: Information in this article was accurate in 2007. The state of the art may have changed since the publication date.
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Food and Drug Administration - April 18, 2007
Richard Klein & Kimberly Struble
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 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. 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: Cicely.Reese@fda.hhs.gov
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
070418
FD070403
SOURCE: Food and Drug Administration (FDA).
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