House Committees demand FDA records on Alzheimer’s drug approval

New York Times

2 September 2021 - The agency approved Biogen’s Aduhelm “despite concerns raised by experts,” committee leaders said in a letter.

Two powerful congressional committees investigating the controversial federal approval of Biogen’s Alzheimer’s drug, Aduhelm, demanded extensive information and documents from the FDA in a letter released on Thursday, making it clear that the committees’ leaders are troubled by unusual actions the agency took in the course of evaluating and approving the drug.

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Michael Wonder

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Michael Wonder

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Medicine , US , Regulation