Harvard doctor urges FDA reforms after Biogen Alzheimer nod

Bloomberg

13 July 2021 - Curtail biomarker use for clearance, Kesselheim writes in JAMA.

A prominent Harvard doctor who was one of three experts to quit a U.S. advisory panel after Biogen’s Alzheimer’s drug Aduhelm was approved said regulators should have tougher standards for granting clearances to unproven medications.

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Michael Wonder

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Michael Wonder

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