Food and Drug Administration

Center for Drug Evaluation and Research

Arthritis Advisory Committee

Silver Spring Holiday Inn, 8777 Georgia Avenue, Silver Spring , MD

Agenda

March 4, 2003

Safety Update, tnf a blocking agents

9:00: Call to Order and Introductions: Steven B. Abramson,, M.D., Acting Chair

Meeting Statement: Kathleen Reedy, Executive Secretary

9:10: Introduction to the Topic and Background: Jeffrey N. Siegel, M.D., FDA

Safety Information: tuberculosis, lymphoma: Li Liang, M.D., FDA

lymphoma, hepatic toxicity: Tim Cote, M.D., FDA

congestive heart failure: Ellis Unger, M.D., FDA

10:30: Break

10:45: Abbott Laboratories: James Lefkowith, MD

Steven Fischkoff, MD

Robert Tarone, PhD

11:30: Amgen Incorporated: Daniel Burge, M.D.

Alan Silman, M.D.

12:15: Centocor Incorporated: Jerome A. Boscia, M.D.

Thomas F. Schaible, Ph.D.

1:00: Open Public Hearing

1:30: Lunch

2:30: Introduction to Questions: Jeffrey N. Siegel, M.D., FDA

Discussion and questions

3:45: Break

5:00: Adjourn