The FDA is increasing scrutiny of overseas clinical trial sites, expanding resources for foreign bioresearch monitoring (BIMO) inspections and revising how it selects foreign locations for audit. In a blog post, Michael Davis—appointed acting director of the Center for Drug Evaluation and Research—said overseas inspections are more costly and harder to execute, and raised concerns about host-country oversight capacity and authority. The agency also flagged generalizability problems when multinational trials include no or limited U.S. participants. The compliance focus includes Phase I and early-stage trials, with FDA plans to update risk-based criteria for inspections and expand reviewer training to better identify sites with potential Good Clinical Practice concerns. Separately, the FDA is launching the Expedited IND Pilot to speed the time to first-in-human studies by pairing drug sponsors with qualified research institutions. Applications are being accepted through Oct. 30, 2026, with FDA leadership saying feedback was incorporated into the pilot’s design and eligibility approach.