Marty Makary resigned as FDA commissioner, with Kyle Diamantas, previously the agency’s top food regulator, stepping in as acting commissioner. The transition comes amid ongoing concerns from biotech leaders about regulatory predictability and the pace of scientific decision-making during leadership turnover. Biopharma groups are likely to watch whether Diamantas maintains the acceleration-oriented reforms attributed to Makary’s tenure, including increased use of AI in review processes and pathways intended to reduce trial and review timelines. The agency’s near-term staffing structure also raises the probability of more acting-role leadership changes. For developers, the leadership shift raises operational questions: how quickly review priorities and internal processes stabilize, and whether current FDA policy frameworks—especially those affecting rare disease and accelerated approval—remain consistent through confirmatory phases and new submissions.