Discover this podcast and so much more

Podcasts are free to enjoy without a subscription. We also offer ebooks, audiobooks, and so much more for just $11.99/month.

A look at the FDA's Aduhelm approval and the potential for regulatory bias

A look at the FDA's Aduhelm approval and the potential for regulatory bias

FromThe Top Line


A look at the FDA's Aduhelm approval and the potential for regulatory bias

FromThe Top Line

ratings:
Length:
15 minutes
Released:
Oct 27, 2023
Format:
Podcast episode

Description

In this episode of “The Top Line,” we delve into the FDA's controversial approval of Aduhelm, a drug for Alzheimer's disease, despite an independent advisory committee's resounding rejection. The decision has sparked questions about potential bias within the regulatory body.  
Genevieve Kanter, Ph.D., a professor at the USC Sol Price School of Public Policy, joins Fierce's Kevin Dunleavy to discuss the implications of a study published in July in JAMA Health Forum, which found the FDA's propensity to favor positive panel recommendations. They explore the impact of this potential bias on drug development and public health. See omnystudio.com/listener for privacy information.
Released:
Oct 27, 2023
Format:
Podcast episode

Titles in the series (99)

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech, and Fierce Pharma recount the latest industry trends and why they matter. We'll analyze the week's biggest business news, from mergers and marketing to drug R&D and device development. Available every Friday morning.