Food and Drug Administration
Center for Drug Evaluation and Research
Arthritis Advisory Committee
Bethesda Holiday Inn, 8120 Wisconsin Avenue, Bethesda, MD
Agenda
July 29, 2002
Pain
8:00 Call to Order and Introductions: Gary S. Firestein, M.D., Chair
Meeting Statement: Kathleen Reedy, Executive Secretary
Welcome: Lee S. Simon, M.D.
Director, Division of Analgesic, AntiInflammatory
and Ophthalmalogic Drug Products
8:15 Introduction: James Witter, M.D., Ph.D.
8:30 1992 Guidance: Christina Fang, M.D.
Sharon Hertz, M.D.
9:00 Basic Science: Clifford J. Woolf, MD, PhD
9:30 Discussion Points: #1, 2
10:00 Break
10:15 Claim Structure: Lee S. Simon, M.D.
10:45 Discussion Points #3, 4
11:15 Back Pain, Chronic Issues: David Borenstein, M.D.
11:45 Discussion Point #5
12:00 Lunch
1:00 Open Public Hearing
3:00 Break
3:15 Introduction: James Witter, M.D., Ph.D.
3:20 Tolerance and Toxicity: Nathaniel P. Katz, MD
3:50 Landmark vs. AUC: Laura Lu, Ph.D.
4:00 Open Discussion of Points: # 1, 2, 3, 4 and 5
5:00 Adjourn
Food and Drug Administration
Center for Drug Evaluation and Research
Arthritis Advisory Committee
Bethesda Holiday Inn, 8120 Wisconsin Avenue, Bethesda, MD
Agenda
July 30, 2002
Pain
8:00 Call to Order and Introductions: Gary S. Firestein, M.D., Chair
Meeting Statement: Kathleen Reedy, Executive Secretary
Welcome: Lee S. Simon, M.D., Director, DAAODP
Comments, Charge: Lawrence Goldkind, M.D.,
Deputy Director, DAAODP
8:15 ABC Metrics of Acute Pain: James Witter, M.D., Ph.D.
8:45 Dosing Intervals: Lawrence Goldkind, M.D.
9:15 Safety Databases for Acute Analgesics: Lourdes Villalba, M. D.
9:45 Discussion Points # 1, 2, 3
10:30 Break
10:45 Open Public Hearing
11:45 Lunch
1:00 Responder Index, a model: Vibeke Strand, MD
1:30 Discussion Point # 4
3:00 Summary: Lee S. Simon, M.D., Director, DAAODP
3:30 Adjourn