FDA opens applications for pilot program to speed up first-in-human testing

The U.S. Food and Drug Administration announced that it is now accepting applications for a pilot program designed to shorten the time required for drug developers to begin first‑in‑human clinical trials.

The initiative, first disclosed in June, offers sponsors a streamlined pathway that could accelerate the start of human testing for new medicines.

The agency says the program aims to improve patient access to experimental therapies and hasten the development of innovative drugs, though specific eligibility criteria and timelines were not detailed.