FDA leadership is in flux after Marty Makary’s resignation, with Kyle Diamantas stepping in as acting commissioner. Multiple reports emphasized that the leadership transition is raising uncertainty for biotech stakeholders because several key roles tied to drug review and regulation are currently staffed as acting positions with limited time authority. Industry focus now centers on whether early policy and process changes—particularly around review timelines, rare disease pathways, and agency adoption of novel review methods—will persist under the acting leadership and the next permanent nominee. For biotech, the immediate impact is operational: uncertainty around review governance can affect planning for submissions, label strategies, and the timing of regulatory interactions.