The FDA launched an expedited investigational new drug (IND) pilot program to speed up timelines for first-in-human studies in the United States. Under “Operation Trialblazer,” the agency will select up to 10 qualified research institutions to support drug sponsors with a rolling review of IND components. The program targets sponsor challenges tied to time and uncertainty when moving from discovery to first-in-human trials, aiming to reduce the advantage drugmakers gain by initiating early studies in countries with faster pathways. Applications are due Oct. 30, and the FDA says the pilot will support up to eight to 10 institution–drugmaker pairings.