Food and Drug Administration
Center for Drug Evaluation and Research
Arthritis Advisory Committee
Gaithersburg Holiday Inn, 2 Montgomery Village Avenue, Gaithersburg, MD
August 17, 2001
Safety Updates:
Enbrel
Ô (etanercept), Immunex,Remicade
Ô (infliximab) CentocorConsultants
CDER:
CBER:Steven B. Abramson, M.D. Michael F. Iademarco, MD, MPH
Chairman of Rheumatology and Medicine Associate Director for Science
Hospital for Joint Diseases Division of Tuberculosis Elimination
301 East 17th Street National Center for HIV, TB, STD Prevention
New York, New York 10003 Centers for Disease Control and Prevention
MS E-10, 1600 Clifton Road
Janet D. Elashoff, Ph.D. Atlanta, Georgia 30333
Director, Division of Biostatistics
Cedars-Sinai Medical Center Joseph Keane, MD
8700 Beverly Boulevard Assistant Professor
Los Angeles, California 90048 Pulmonary Center, R-304
Boston University School of Medicine
Patient Representative: 80 E. Concord Street
Leona M. Malone, MSW Boston, Massachusetts 02118
8D Lexington Lane East
Palm Beach Gardens, Florida 33418 Julie M. Vose, M.D.
Professor and Vice Chairman
David Wofsy, M.D. Department of Internal Medicine
Professor of Medicine University of Nebraska Medical Center
Director, Clinical Trials Center 983332 Nebraska Medical Center
Department of Medicine Omaha, Nebraska 68198-3332
Division of Rheumatology
University of California at San Francisco
VA Medical Center
4150 Clement Drive, Building 2, Room 531
San Francisco, California 94121