FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway
FDA Law
JANUARY 12, 2025
Lastly, the reforms enacted by FDORA required that FDA publish guidance on early consultation with FDA to identify novel surrogate or intermediate clinical endpoints, use of novel trials designs for postapproval studies, the expedited withdrawal procedures, and considerations related to the use of surrogate and intermediate clinical endpoints.
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