The FDA announced plans to increase resources for overseas clinical trial facility inspections and to update risk-based criteria used to select sites for audit. The agency also flagged capacity challenges in host nations, including whether local regulators can provide oversight at the level the FDA expects. In a blog post by acting CDER director Michael Davis, the FDA said it is “more challenging and costly” to inspect foreign sites in the same manner as domestic facilities—especially when unannounced audits are involved. The FDA further raised concerns about how easily results from multiregional trials generalize to U.S. patients. The inspection plan targets bioresearch monitoring (BIMO) for phase I and early-stage trials and includes an expansion of training for medical product reviewers to better identify sites with potential Good Clinical Practice deficiencies. The policy shift is likely to affect how sponsors plan global trial footprints, particularly where studies include limited or no U.S. participation and where regulatory familiarity with local oversight structures varies.