Food and Drug Administration

Center for Drug Evaluation and Research

Arthritis Advisory Committee

CDER Advisory Committee Conference Room

5630 Fishers Lane, Room 1066, Rockville, MD

Agenda

April 19, 2001

NDA # 21-239 ASLERA™ (prasterone, Genelabs Technologies, Inc.)

 

 

8:00 Call to Order and Introductions: E. Nigel Harris, M.D., Acting Chair

Meeting Statement: Kathleen Reedy, Executive Secretary

8:15 Welcome and Introduction: Jonca C. Bull, M.D., Acting Director

Division of Anti-Inflammatory, Analgesic, and Ophthalmic Drug Products

Regulatory Background: Kent R. Johnson, M.D., Medical Officer, DAAODP

8:30 Genelabs Technologies Inc. Presentation

Overview: Marc Gurwith, MD, JD, Vice President, Drug Development,

Chief Medical Officer, Genelabs Technologies, Inc.

Introduction: Robert Lahita, MD, PhD, Professor of Medicine,

Saint Vincentís Medical Center

Summary of Efficacy: Michelle Petri, MD, MPH, Associate Professor of Medicine

Johns Hopkins Medical Center

Clinical Perspective: Murray Urowitz, MD, FRCPC, Professor of Medicine

University of Toronto

10:00 Break

10:15 FDA Presentation

Pharmacology/Toxicology: Susan Wilson, D.V.M. , Ph.D.

Clinical Pharmacology: Abimbola Adebowale, Ph.D.

Medical: Kent R. Johnson, M.D.

Statistical: Laura Lu, Ph.D.

11:15 Open Public Hearing

11:45 Lunch

1:00 Discussion and Questions:

3:30 Summary and Review

4:00 Adjourn