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The federal watchdog at the Department of Health and Human Services will review the process used by the Food and Drug Administration to approve the Alzheimer’s drug sold by Biogen (BIIB), which has caused unprecedented controversy over regulatory standards, STAT reports. The HHS Office of Inspector General will examine the accelerated approval path the FDA increasingly uses to speed approvals for drugs to treat serious conditions and fill unmet medical needs. This was the route used by the agency when it OK’d the Aduhelm drug for Alzheimer’s.

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