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.
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The FDA commissioner said several aspects of the advisory committee system should be considered for updates or adjustment. A revamp effort has predated his return trip to the agency.
Biogen’s stake in Samsung Bioepis has been fully acquired by former partner Samsung Biologics, following an announcement of the deal in January.
FOIA exemption does not apply to medical and statistical reviews of its sNDA, company claims. It says it needs the information to adapt its development program and determine if the agency made an error.