Surrogate Endpoint ‘Reasonably Likely’ Decision Process An ‘Uncertain Standard,’ Industry Says

25 Mar 2025

The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.

Question mark — The FDA's accelerated approval draft guidance describes an "uncertain standard" for identifying acceptable endpoints, PhRMA said. (Shutterstock)

Key Takeaways

Stakeholders said the FDA’s draft guidance on accelerated approval does not provide a clear path for developing acceptable, reasonably likely endpoints, and should be clarified.

The US Food and Drug Administration’s accelerated approval draft guidance has left stakeholders wanting more clarity on the process for...