The FDA signaled tighter oversight of early-stage clinical data generated outside the United States, citing concerns about regulatory capacity in host countries and the ability to conduct inspections. In a policy communication, the agency described challenges related to unannounced audits abroad and how it may limit generalizability to US patients. Acting CDER director Michael Davis outlined plans to expand foreign bioresearch monitoring (BIMO) inspection resources, update risk-based criteria for selecting overseas sites, and broaden reviewer training to better identify potential Good Clinical Practice issues. The approach stops short of a blanket restriction while increasing compliance pressure on certain trial arrangements.