Drug Safety and Risk Management Advisory
Committee Meeting
and the
Dermatologic and Ophthalmic Drugs
Advisory Committee
February 26 & 27, 2004
Consultants (Voting)
Wilma
F. Bergfeld, M.D.
Head of
Clinical Research
Dept. of
Dermatology
Michael
E. Bigby, M.D.
Assistant
Professor of Dermatology
Libby 134
Margaret
Honein, Ph.D., M.P.H.
Centers for Disease Control and Prevention
& Developmental Disabilities
Division of Birth Defects &
Developmental Disabilities
Mailstop E-86
Arthur H.
Kibbe., Ph.D.
Department
of Pharmaceutical Science
Sarah Sellers, Pharm.D.
121 Rose
Terrace
Amarilys Vega, M.D., Ph.D.
6305 Mellow Twilight Court
Jurgen Venitz, M.D., Ph.D.
222
Guest Speakers (Non-voting)
Richard K. Miller, Ph.D.
Professor and Associate Chair of
Obstetrics and Gynecology
Director, PEDECS
(NIEHS/NY Teratogen Information Service)
Room 5-7550
Richard A. Wagner, Pharm.D.
Leader
Kaiser Permanente Drug Use Management
Drug Safety and Risk Management Advisory
Committee Meeting
and the
Dermatologic and Ophthalmic Drugs
Advisory Committee
February 26 & 27, 2004
FDA Staff
Mark Avigan, M.D., C.M.
Director, Division of Drug
Risk Evaluation
Office of
Pharmacoepidemiology
and Statistical Science
Center for Drug Evaluation
and Research
HFD-400
Allen Brinker, M.D., M.S.
Lead Medical Officer
Office of
Pharmacoepidemiology
and Statistical Science
Office of Drug Safety
Center for Drug Evaluation
and Research
HFD-400
Gary Buehler, R.Ph.
Director, Office of Generic
Drugs
Office of Pharmaceutical
Science
Center for Drug Evaluation
and Research
HFD-600
Jonca Bull, M.D.
Director, Office of Drug
Evaluation V
Office of New Drugs
Center for Drug Evaluation
and Research
HFD-105
Steven Galson, M.D., M.P.H.
Acting Director
Center for Drug Evaluation
and Research
HFD-001
John Jenkins, M.D.
Director, Office of New
Drugs
Center for Drug Evaluation
and Research
HFD-020
Sandra Kweder, M.D.
Deputy Director, Office of
New Drugs
Center for Drug Evaluation and
Research
HFD- 020
Jill Lindstrom, M.D.
Medical Officer
Division of Dermatologic and
Dental Drug Products
Office of Drug Evaluation V
Office of New Drugs
Center for Drug Evaluation
and Research
HFD-540
9201 Corporate Boulevard
Marilyn Pitts, Pharm.D.
Safety Evaluator
Division of Drug Risk
Evaluation
Office of
Pharmacoepidemiology
and Statistical Science
Center for Drug Evaluation
and Research
HFD-430
Paul Seligman, M.D., M.P.H.
Director, Office of
Pharmacoepidemiology
and Statistical Science
Center for Drug Evaluation
and Research
HFD-030
Anne Trontell, M.D., M.P.H.
Deputy Director, Office of
Drug Safety
Center for Drug Evaluation
and Research
HFD-400
Kathleen Uhl, M.D.
Team Leader, Pregnancy
Labeling Team
Office of New Drugs
Center for Drug Evaluation
and Research
HFD-020
Jonathan Wilkin, M.D.
Director
Division of Dermatologic and
Dental Drug Products
Office of Drug Evaluation V
Office of New Drugs
Center for Drug Evaluation
and Research
HFD-540
9201 Corporate Boulevard