FDA Commissioner Robert Califf defended the decision to approve the controversial Alzheimer’s drug Aduhelm after a congressional probe found “inappropriate” collaboration between the agency and Biogen
U.S. Food and Drug Administration Commissioner Robert Califf defended his agency’s decision to approve the Alzheimer’sfound close cooperation between the drug’s sponsor and regulators.
Findings released late last year from the then-Democratic-led Oversight and Reform Committee and the Energy and Commerce Committee faulted the FDA for holding an unusual number of meetings with Biogen Inc. while it weighed approval of Biogen’s Alzheimer’s treatment, Aduhelm, as well as for co-authoring with the company a briefing document presented to outside advisers.
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