FDA opens pilot to accelerate phase 1 trials with fast IND reviews

The Food and Drug Administration announced a new pilot program aimed at speeding up early-stage clinical trials in the United States. The initiative pairs drug sponsors with qualified research institutions, such as contract research organizations and academic medical centers, to submit investigational new drug applications on a rolling basis.

The pilot will select about eight to ten sponsor-institution pairs and accept submissions through October 30. FDA staff will review the INDs more quickly, hoping to reduce the lag that has made U.S. phase 1 trials slower than those in China and Australia.

Acting FDA Commissioner Kyle Diamantas said the program tests whether these partnerships can also hasten the steps that follow FDA clearance. The effort is part of the broader Operation Trial Blazer announced earlier this year and may expand to other HHS initiatives.