FDA Asked Biogen To Speed Up Postmarket Data On Aduhelm

By Beth Wang / July 6, 2021 at 12:14 PM
A week after granting Accelerated Approval to Biogen’s controversial Alzheimer’s drug, FDA leaders met with company officials and asked them to commit to speeding up collection of postmarket data. Biogen initially said its postmarket study would be done by 2030, exasperating one FDA adviser who said nine years is too long to wait. Now, the company says it hopes to complete the trial earlier. FDA and Biogen are facing increased scrutiny over their close collaboration prior to and after the...


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