The FDA announced two policy moves that could reshape regulatory timelines: a pilot program to pay quarterly bonuses to drug reviewers for time‑savings, and a shift toward treating one adequate, well‑controlled trial as a default basis for marketing applications. Commissioner Marty Makary framed the bonus pilot as recognition for efficiency gains and the trial default as a measure to speed development. Industry and ethicists have raised questions about incentives and global alignment: pay‑for‑speed models could create perceived pressure to accelerate reviews, while a single‑trial default departs from some established global and payer expectations. "One adequate trial" refers to the agency accepting a single robust study as sufficient for approval rather than the traditional two pivotal trials standard.