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FDA Maraviroc Approval Hearing April 24
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The Food and Drug Administration (FDA) will hold a meeting of its Antiviral Drugs Advisory Committee on April 24, 2007, from 8 a.m. to 4 p.m. at the Food and Drug Administration, Center for Drug Evaluation and Research Advisory Committee Conference Room, Room 1066, 5630 Fishers Lane, Rockville, MD.
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 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.
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person (see below) on or before April 3, 2007.
Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. 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 March 26, 2007. Time allotted for each presentation may be limited, depending on the number of people who wish to speak.
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 March 27, 2007.
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 at least 7 days in advance of the meeting.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
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