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
Later, in 1993, in private practice Sasinowski advocated for the first use of Accelerated Approval outside of AIDS and cancer, when Dr. Janet Woodcock approved Betaseron as the first drug for multiple sclerosis. This has been a decision we’ve been closely following. Key Takeaways from the Aduhelm Label: What’s in It and What Isn’t.
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