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

April 19, 2001

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

 

 

Arthritis Advisory Committee Consultants

Janet D. Elashoff, Ph.D.

Director, Division of Biostatistics

Cedars-Sinai Medical Center

8700 Beverly Boulevard

Los Angeles, California 90048

 

Matthew H. Liang, M.D., M.P.H.

Professor of Medicine

Department of Medicine

Division of Rheumatology/Immunology

Harvard Medical School

Brigham and Women's Hospital

75 Francis Street

Boston, Massachusetts 02115

 

Guests:

Jack Klippel, M.D.

Medical Director

Arthritis Foundation

4455 Connecticut Avenue NW

Washington, D.C. 20008

 

Earl D. Silverman, M.D.

Director, Pediatric SLE Clinic

Professor of Pediatrics and Immunology

Division of Rheumatology

Hospital for Sick Children

Room 8253 Elm Wing

555 University Avenue

Toronto, Ontario M5G1X8 Canada

 

Barbara C. Tilley, Ph.D.

Medical University of South Carolina

College of Medicine

Biometry and Epidemiology

135 Rutledge Avenue

P.O. Box 2550551

Charleston, SC 29425

 

Patient Representative

Pamela J. Fields

Education Director

Ohio River Valley Arthritis Foundation

7811 Laurel Drive

Cincinnati, OH 45243