The FDA launched two related moves aimed at shifting more early drug development into the U.S. and tightening inspection capacity abroad. First, it opened applications for an expedited investigational new drug (IND) pilot under Operation Trialblazer, offering rolling review support for up to 10 qualified institution–sponsor pairings. Separately, the agency plans to expand foreign bioresearch monitoring (BIMO) inspections and refine risk-based audit site selection.