Drug Safety and Risk Management Advisory Committee
(DSaRM)
Slides
|
Open
Public Hearing Speakers |
|
|
|
Diane Thiboutot, M.D. |
|
Office
of Drug Safety Updates |
Gerald Dal Pan, M.D., M.H.S. Director, Office of Drug Safety
(ODS) |
|
New
Drug Safety Initiatives and the Drug Safety Oversight Board |
Susan
Cummins, M.D., M.P.H. Executive
Director, Drug
Safety Oversight Board |
|
An
Update on NSAID Labeling and Data Review |
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 |
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 [PPT] |
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. |