FDA launches Operation TrialBlazer to accelerate early-stage drug trials and bring research back to the U.S.

The FDA announced it is now accepting applications for Operation TrialBlazer, an expedited IND pilot program.

The program pairs drug sponsors with qualified U.S. research institutions to cut the risk of clinical holds and shorten the time to first-in-human studies, potentially shaving up to a year from early-stage development.

The initial application window closes on Oct. 30, and the initiative is part of a broader HHS effort to restore American leadership in clinical trials by reshoring early studies.