Richard Pazdur (via AACR)
Accelerated approval reforms need meaningful confirmatory trial improvements, professors write in Science
Outside of Covid-19, 2021 has been the year of the accelerated approval.
Beginning last spring, FDA openly challenged six “dangling” accelerated approvals (hadn’t confirmed their clinical benefit yet), three of which were later pulled by the companies.
Then in June, FDA pulled out the accelerated approval pathway, seemingly out of nowhere, to sign off on Biogen’s controversial Alzheimer’s drug Aduhelm. It hadn’t even been mentioned at the drug’s adcomm.
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