The FDA said it will boost resources for overseas clinical trial facility inspections and update risk-based criteria for selecting foreign sites for audit. Acting CDER director Michael Davis laid out the rationale in a blog post, citing challenges inspecting overseas locations “in the same manner” as domestic sites, including unannounced audits. The agency also flagged capacity and authority gaps in host countries to provide Good Clinical Practice oversight on par with FDA expectations, and it raised concerns about whether “multiregional” trials without meaningful US enrollment can generalize to US patients. For companies running global Phase I and early-stage programs, the change increases the compliance burden for cross-border studies and may affect site selection and trial design strategies.