The FDA's accelerated approval pathway is a hot topic in health policy. Recent controversies include the approval of aducanumab (Aduhelm) for Alzheimer's disease and the overdue market withdrawal of 17α-hydroxyprogesterone caproate (17-OHPC; Makena); meanwhile, multiple indications for cancer drugs have been withdrawn in recent years after failed confirmatory trials.
While many criticize the process and call upon Congress for reform, others see the pathway as an essential tool to bring much-needed therapies to market, especially treatments for rare diseases.
In this Instagram Live session, an expert panel will dive into the world of accelerated drug approval to share their perspectives and answer audience questions. See you there!
Featuring:
Jeremy Faust, MD (moderator) editor-in-chief at 鶹ý ()
Aaron Kesselheim, MD, JD, MPH, director, the Program on Regulation, Therapeutics, and Law at Harvard Medical School and Brigham & Women's Hospital in Boston ()
Holly Fernandez Lynch, JD, MBE, assistant professor of Medical Ethics in the Department of Medical Ethics and Health Policy at the Perelman School of Medicine in Philadelphia ()
How do I join? Follow on Instagram!
When is the event? Tune in Monday, October 23 at 12:30 p.m. ET
Can I submit questions? Yes, we encourage questions! Submit your questions prior to the event by commenting below.
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Makena Is Just the Latest in Accelerated Approval Mayhem
To Prescribe or Not to Prescribe: Lecanemab Wins FDA Accelerated Approval
Why Does Makena Remain on the Market?
Alzheimer's Drug Wins Full FDA Approval
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