RE:RE:RE:RE:RE:RE:RE:How does Accelerated Approval work
What does Accelerated Approval mean?
Accelerated approval refers to a regulatory pathway of the FDA that allows drugs for serious conditions, which are intended to fill an unmet medical need, to be approved based on a surrogate endpoint. This pathway is typically faster in obtaining the necessary data from clinical trials than the traditional approval pathway based on clinical endpoints (how a person feels, functions or survives).
https://curesanfilippofoundation.org/2024/06/ultragenyx-ux111-accelerated-approval-means-for-sanfilippo/