The FDA said it will increase resources for foreign bioresearch monitoring (BIMO) inspections and update risk-based criteria used to select overseas clinical sites for audit. Acting Center for Drug Evaluation and Research director Michael Davis flagged concerns about regulatory capacity in host countries and the generalizability of multiregional trials when the U.S. enrollment footprint is absent or minimal. The agency plans to focus on Phase I and early-stage trials and expand training for medical product reviewers to better identify sites where good clinical practice concerns may be elevated. The move is aimed at addressing gaps FDA cited in unannounced audits abroad. Biotech sponsors running global studies should expect tighter scrutiny of site quality, documentation practices, and representativeness—potentially affecting timelines, data reconciliation strategies, and the robustness of NDA/MAA submissions that rely on overseas datasets.