The FDA announced it will expand resources for overseas bioresearch monitoring (BIMO) inspections and update risk-based criteria for selecting foreign clinical trial sites for audit. The move targets concerns about regulatory oversight capacity abroad, including the difficulty and cost of performing unannounced inspections. In its blog post, FDA acting leadership linked the plan to challenges with host-nation authority and oversight systems that may not match FDA Good Clinical Practice expectations. The agency also raised concerns about generalizability when U.S. patients are absent from multiregional trials. The policy shift signals tighter scrutiny for trials conducted primarily outside the U.S., particularly for early-stage studies where FDA says focus will include Phase I and other early clinical work.