DERMATOLOGIC AND OPHTHALMIC DRUGS ADVISORY COMMITTEE

September 18-19, 2000

Slides

Accutane

Opening

September 18, 2000

Food and Drug Administration 

Engineering a Risk Management Program

Accutane and Pregnancy Exposure

Hoffmann-La Roche Inc.

Introduction, Russell Ellison, MD, Roche Laboratories, Inc ppt

Benefits of Accutane, Guy F Webster MD, PhD, Jefferson Medical College ppt html

Accutane Use and Epidemiology, John E La Flore, MD, MSPH, Hoffmann-La Roche Inc ppt

An Assessment of the Accutane (Isotretinoin) Pregnancy Prevention Program, Allena A Mitchell, MD, Carla Van Bennekom, RN, MPH, Carol Louik, ScD, Boston University School of Public Health ppt

Targeted Pregnancy Prevention Program for Women on Accutane (Isotretinoin), Eileen Enny Leach MPH ppt

Risk Management Options, Russell Ellison, MD, Roche Laboratories, Inc ppt

Psychiatric Events Risk Management Issues