FDA’s Accelerated Approval of Biogen’s Aduhelm for Alzheimer’s: A Sign of Applying the Emergency Use Standard Beyond COVID?
FDA Law Blog
JUNE 7, 2021
Subpart H) pathway in 2014, then issued it as final guidance in January 2019. It is noteworthy that this sentence that no clinical benefit has been established was deemed by FDA as unnecessary for Aduhelm to provide additional context beyond that the approval is based on reduction in amyloid beta plaques. What do we mean?
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