Aduhelm Approval Firestorm Raises Question: What Are US FDA Advisory Committees For, Anyway?

After three panel members resign over agency’s approval of Biogen’s Alzheimer’s disease drug, the ‘billion-dollar question’ is why FDA provided so little information to justify use of beta amyloid as a surrogate endpoint, one panelist asserts, especially since the agency expressly disavowed the pathway during the advisory committee meeting.

advisory committee firestorm
US FDA approval of Alzheimer's disease drug Aduhelm riles advisory panel • Source: photo illustration/Alamy images

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