The U.S. FDA launched a pilot program intended to speed up Phase I investigational new drug (IND) preparation by pairing sponsors with prequalified research institutions. Once matched, sponsors and research sites can file components of the IND through a rolling process during the pre-IND phase, rather than waiting for all elements to be ready at once. The agency said the approach is designed to reduce delays between IND preparation and first-in-human study initiation, and it includes coordination of parallel activities such as Institutional Review Board review and site activation. The pilot will select eight to 10 projects, with applications accepted until October 30. By using prequalified institutions—QRIs—the FDA aims to generate evidence that could inform future modernization of how the agency supports early-stage clinical development.