Topic

regulatory-submissions

Endpoint evidence prepared for regulatory interactions and submissions.

Regulatory Evidence

How to Construct a COA Endpoint Under Draft PFDD Guidance 4

How clinical trial teams construct endpoints from fit-for-purpose COAs and prespecify meaningful-change interpretation plans under draft PFDD Guidance 4.

Sep 1521 minBy Ran Chen

Endpoint Strategy

FDA Surrogate Endpoint Table: How to Use It Without Assuming Qualification

How clinical development teams can evaluate FDA's surrogate endpoint table across indication, mechanism, and approval pathway without conflating listing with formal qualification.

Sep 1418 minBy Ran Chen