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. However, the FDA guidance goes on to say in some cases, additional context is needed by specifically inserting a sentence in the indications statement that: no clinical benefit has been established. This has been a decision we’ve been closely following.
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