The FDA said it will increase resources for foreign bioresearch monitoring (BIMO) inspections and update risk-based criteria for selecting overseas clinical trial sites for audits. Acting Director Michael Davis, writing in a blog post, pointed to challenges with conducting unannounced inspections abroad and questions about whether host countries can support oversight at FDA expectations. The agency flagged concerns about generalizability when multi-regional trials include no U.S. patients or only a small share. FDA plans also include expanding training programs for medical product reviewers to better identify higher-risk foreign sites where studies may not follow Good Clinical Practice. Separately, reporting indicates the FDA is grappling with China biotech’s rising role across the regulator, reflecting internal and policy pressure to understand and manage data quality, compliance and scale. Together, the actions signal tighter scrutiny on the mechanics of overseas trial conduct and the evidentiary bridge to U.S. regulators, which could reshape trial designs, monitoring plans and documentation practices for global development programs.