Food and Drug Administration

Drug Safety and Risk Management Advisory Committee (DSaRM)





Open Public Hearing Speakers

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Diane Thiboutot, M.D.

American Academy of Dermatology Association     [PPT]

Office of Drug Safety Updates

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Gerald Dal Pan, M.D., M.H.S.

Director, Office of Drug Safety (ODS)

New Drug Safety Initiatives and the Drug Safety Oversight Board

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Susan Cummins, M.D., M.P.H.

Executive Director,

Drug Safety Oversight Board

An Update on NSAID Labeling and Data Review

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Sharon Hertz, M.D.

Deputy Director, Division of Analgesia, Anesthetic and Rheumatology Products

Office of Non-Prescription Products,

Office of New Drugs (OND)

Introduction to Isotretinoin Risk Management Program

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Jill Lindstrom, M.D., FAAD

Acting Deputy Director, Division of Dermatology and Dental Products, Office of Drug Evaluation III, OND


iPLEDGE Isotretinoin Pregnancy Risk Management Program


Susan Ackermann Shiff, PhD

Global Head, Risk Management

Hoffmann-La Roche Inc.


Christine Mundkur

Senior VP, Quality and Regulatory Counsel,

Barr Laboratories, Inc.


James Shamp

Director, Covance, Inc.