The U.S. FDA launched a pilot program pairing drug sponsors with prequalified research institutions (QRIs) to expedite preparation for Phase I studies. Under the model, sponsors and selected sites can file trial plans through a rolling review approach during the pre-IND phase, rather than waiting for all components to be ready. The agency said the program aims to reduce delays between IND preparation and first-in-human initiation while coordinating parallel activities like Institutional Review Board review and site activation. Applications are being accepted until October 30, with FDA staff expected to select eight to 10 projects.