RE:RE:RE:How does Accelerated Approval work January 2024 - FDA Unveils Groundbreaking Rare Disease Guidance Document
For drugs eligible to follow the Accelerated Approval pathway, a determination of safety and effectiveness may be made based not on measures of direct clinical benefit, but rather on one of two alternative endpoints: (1) a surrogate endpoint that is reasonably likely to predict clinical benefit; or (2) an intermediate clinical endpoint that is reasonably likely to predict clinical benefit. Use of such endpoints may enable the drug to be studied for a shorter treatment duration and receive Accelerated Approval based on these findings. Importantly, however, for products approved under the Accelerated Approval pathway, FDA requires post-approval studies designed to confirm clinical benefit, and, among other things, may withdraw an accelerated approval product from the market for failure to confirm clinical benefit.
https://www.fda.gov/media/175253/download?attachment