The U.S. FDA launched and began accepting applications for its Expedited Investigational New Drug (IND) pilot, aiming to shorten the timeline for drugs to enter first-in-human studies by removing IND friction. The agency says it will partner drug sponsors with qualified research institutions (QRIs) that can support efficient IND package development. Separate FDA reporting in the same initiative points to a focus on rolling submission workflows and the integration of public feedback into eligibility and program design. The FDA also set an application window that runs through October 30, 2026. The expedited pilot is framed as part of a broader push to keep the U.S. competitive as early-stage trials increasingly shift to other jurisdictions, including China and Australia.