Food and Drug Administration

Drug Safety and Risk Management Advisory Committee

and the

Dermatologic and Ophthalmic Drugs Advisory Committee

February 26, 2004


Isotretinoin - Background and Regulatory History, Dr. Jill Lindstrom, MD, FDA (HTM) (PPT)

Presentation by Hoffmann-La Roche, Inc.(HTM) (PPT)

Isotretinoin Risk Management Program - Background Information, Frank Sisto, Mylan Laboratories, Inc. (HTM) (PPT)

Isotretinoin Survey, Dr. Allen Mitchell, MD and Cara Van Bennekom, RN, MPH, Slone Epidemiology Center at Boston Unversity (HTM) (PPT)

Isotretinoin Enhanced Risk Management Program, Robert Pollock, Lachman Consultant Services, Inc. (HTM) (PPT)

Overview - Isotretinoin Pregnancy Exposures: Spontaneous Reports 1-Year Prior to, & 1-Year After Implementation of the Current RMP, Dr. Marilyn Pitts, PharmD, FDA (HTM) (PPT)

Isotretinoin Preganancy Prevention Program Evaluation - Prescription Compliance Survey and Patient Surveys, Dr. Allen Brinker, MD, MS, FDA (HTM) (PPT)

The KP Med-SMART Isotretinoin Risk Management and Monitoring Program, Dr. Richard Wagner, PharmD and Dr. T. Cheetham, PharmD, MS, Kaiser Permanente California (HTM) (PPT)

Interim Report OTIS - North American Isotretinoin Information and Survey Line, Richard Miller, OTIS (HTM) (PPT)

Risk Management Options for Pregnancy Prevention, Dr. Kathleen Uhl, MD, FDA (HTM) (PPT)

S.T.E.P.S.® Program Review - Backup Information (HTM) (PPT)

Selecting Risk Management Tools: FDA Considerations and Experience, Dr. Anne Trontell, MD, MPH, FDA (HTM) (PPT)