The FDA launched a pilot program designed to expedite Phase I trials by pairing sponsors with prequalified research institutions. Under the initiative, qualified research institutions (QRIs) support IND preparation, allowing FDA to conduct rolling review of components during the pre-IND phase rather than waiting for all materials up front. The program is intended to reduce the gap between preclinical package completion and first-in-human study initiation, addressing bottlenecks tied to protocol review by Institutional Review Boards and site activation. The FDA said it expects eight to ten projects to be selected, with applications accepted until October 30. Biopharma sponsors will now have a new pathway to compress timelines, though participation will depend on eligibility and the ability of sites to meet the FDA’s accreditation expectations for early-stage expertise.