FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway
FDA Law Blog
JANUARY 12, 2025
As such, we will publish a separate blog post focused on confirmatory trials and how FDA is interpreting this key provision of its accelerated approval authority. Further, the recent approval of Kebilidi for AADC is likely to follow this approach, suggesting that FDA may be gaining some comfort with type of ICE-clinical benefit relationship.
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