Accelerated Drug Approval and Aducanumab - Aaron Kesselheim
Speaker:
Aaron Kesselheim, MD, JD, MPH, Professor of Medicine at Harvard Medical School
Date:
September 23, 2021
at 4:00PM
- 5:30PM
Dr. Aaron Kesselheim, former member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee who resigned over the agency’s approval of Aducanumab, will speak about the FDA’s accelerated approval pathway, how it is implemented, and how it was applied in the controversial Aducanumab case – which he dubbed the “worst drug approval decision in recent U.S. history.” Dr. Kesselheim will also give suggestions for the future. This should be a fascinating talk with wide implications for all future accelerated drug approval pathways.