The FDA plans to increase resources for overseas clinical trial site inspections and update risk-based criteria for selecting foreign sites for audit. Acting CDER Director Michael Davis outlined the move, citing challenges with conducting unannounced inspections abroad and uncertainty about host-country regulatory capacity and authority. The agency also flagged concerns about whether multi-regional trials without meaningful U.S. patient enrollment can support generalizability to American patients. FDA’s stated focus includes Phase I and early-stage trials through added foreign bioresearch monitoring (BIMO) inspection coverage and expanded reviewer training to better detect Good Clinical Practice concerns. The shift signals tighter compliance expectations for trials conducted outside the U.S., increasing the pressure on sponsors using foreign sites to demonstrate consistent oversight and audit-ready documentation.