FDA leadership is signaling regulatory adjustments to speed early‑phase trials and respond to global competition, with Commissioner Marty Makary describing agency plans to rework Phase 1 regulations to streamline first‑in‑human studies. At the same time, STAT reported the FDA delayed two drug reviews under a new voucher program, illustrating implementation challenges and staffing or policy friction. Makary’s comments frame the agency’s push to accelerate U.S. trial starts amid rising competition from China in early clinical research, while the STAT report underscores transitional delays as new regulatory mechanics are operationalized. Stakeholders should expect changing review timelines and possible new procedural guidance for early‑phase sponsors. Companies planning Phase 1 starts and those relying on voucher pathways must track updated FDA guidance and potential shifts in review cadence that could affect development timelines and go‑to‑market strategies.