FDA leaders signaled a substantive shift in regulatory practice by proposing a default approval pathway that accepts one pivotal clinical trial in many cases and by floating user-fee changes to favor early-stage trials run in the U.S. FDA Commissioner Marty Makary told STAT the agency will move toward one trial as the default when it delivers adequate statistical power; separately, agency meeting minutes show PDUFA negotiators discussed lowering fees for domestic early-stage work and adding fees for overseas phase 1 activity. The moves address both evidentiary standards and industrial policy: they could shorten development pathways for certain programs while financially incentivizing U.S.-based clinical research. PDUFA (Prescription Drug User Fee Act) funds much of the FDA’s review work and fee changes would alter sponsor economics.