The US Food and Drug Administration’s accelerated approval of Biogen, Inc.’s Aduhelm (aducanumab-avwa) has been the most controversial event in the Rx policy sphere – until the Centers for Medicare and Medicaid Services’ effort to essentially undo it through a national coverage determination impacting even traditional approvals of Alzheimer’s drugs.
Accelerated Approval: How The Aduhelm Probes Will, And Won’t, Impact The Debate
Even as the US FDA can expect to be put through the ringer with the congressional and HHS Inspector General probes, the process could have some upsides for the agency, according to former officials who have been through such scrutiny.
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