cder - calender

Lifted from the FDA website:


U.S. Food and Drug Administration • Center for Drug Evaluation and Research


CDER Calendar




Arthritis Advisory Committee

Date and Time: The meeting will be held on March 4, 2003, from 9 a.m. to 4 p.m. and on March 5, 2003, from 8 a.m. to 5 p.m.

Location: Holiday Inn, Kennedy Ballroom, 8777 Georgia Avenue, Silver Spring, MD.

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 or email: [email protected]

Agenda: On March 4, 2003, the committee will hear a safety update on tnf alpha inhibitors; Humira (adalimumab), Abbott Laboratories; Remicade (infliximab) 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.