FDA Commissioner Marty Makary told STAT the agency plans to make one pivotal clinical trial the default for approvals in many cases, departing from the historical two‑trial expectation. Makary framed the change as relying on well‑designed single studies to achieve statistical power when appropriate. At the same time, FDA negotiators floated PDUFA proposals to cut fees for companies running early‑stage trials inside the U.S. and to add fees for firms developing drugs abroad—moves intended to incentivize U.S. clinical activity. Both actions surfaced during PDUFA and policy discussions and would materially affect clinical development planning and sponsor economics if adopted.