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FDA Commissioner defends FDA’s approval of Biogen’s Aduhelm, WSJ reports
The Fly

FDA Commissioner defends FDA’s approval of Biogen’s Aduhelm, WSJ reports

U.S. Food and Drug Administration, FDA, Commissioner Robert Califf defended the FDA’s decision to approve Biogen’s Alzheimer’s drug Aduhelm after a close cooperation between the drug’s sponsor and regulators was discovered following an investigation led by House Democrats, Liz Whyte of The Wall Street Journal reports. The then-Democratic-led Oversight and Reform Committee and the Energy and Commerce Committee faulted the FDA for holding an unusual amount of meetings with Biogen as the agency weighed approving Aduhelm. The investigation found the FDA had an atypical number of meetings, calls, or substantive emails as Biogen prepared to seek approval for the drug, with 66 of those improperly documented. Reference Link

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