Posted by Michael Wonder on 04 Aug 2021
Federal watchdog will review the controversial FDA approval of Biogen’s Alzheimer’s drug
4 August 2021 - The federal watchdog at the Department of Health and Human Services will review the process used by the FDA to approve the Alzheimer’s drug sold by Biogen, which has caused unprecedented controversy over regulatory standards.
Specifically, the HHS Office of Inspector General will examine the accelerated approval pathway that the FDA increasingly uses to speed approvals for medicines to treat serious conditions and fill an unmet medical need.
