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Arthritis Advisory Committee

Agenda:
On March 4, 2003, the committee will hear a safety update on tnf alpha inhibitors; Humira (adalimumab), Abbott Laboratories; REMICADE (infliximad), Centocor; and ENBREL (etanercept), Immunex.

On March 5, 2003, the committee will discuss the approved product new drug application (NDA) 20-905, ARAVA, (leflunomide), Aventis Pharmaceuticals, Inc., clinical data regarding efficacy for improvement in physical function in rheumatoid arthritis, as well as a safety update. The background material for this meeting will be posted on the Internet when available or 1-working day before the meeting at: /ohrms/dockets/ac/acmenu.htm.

Procedure:
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 by February 25, 2003. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on March 4, 2003, and between approximately 8:30 a.m. and 9a.m. and ll:3O a.m. and 12 noon on March 5, 2003. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before February 25, 2003, 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. 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 LaNise Giles at 301-827-7001 at least 7 days in advance of the meeting.

Contact Person:
Kathleen Reedy or LaNise Giles, 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: reedyk@cder.fda.gov, or FDA Advisory Committee Information Line, l-800-741-8138 (301-443-0572 in the Washington, DC area), code 12532. Please call the Information Line for up-to-date information on this meeting.

[Full FR Notice]