FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway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. For those somewhat familiar with accelerated approval and surrogate endpoints, you will find that the guidance reiterates a now well-established framework.
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