US FDA’s Post-Aduhelm Reforms Include Updated Alzheimer’s Development Guidance, Record-Keeping On Sponsor Meetings

Agency already had an action plan in hand to address concerns with the aducanumab review even before the controversial approval, but it has not been fully implemented yet. A House committee report is another nudge.

Alzheimer's seas perspectives
FDA will continue to have to navigate the treacherous seas of the Aduhelm controversy in 2023. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

The US Food and Drug Administration has several policy updates planned to address elements of the controversial review of Biogen, Inc./Eisai Co., Ltd.’s Aduhelm, but the timeline for the agency to finally implement them remains unclear.

That’s among the revelations from a House report investigating the approval of the Alzheimer’s treatment, which recommended that FDA...

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