Marty Makary resigned as FDA commissioner, and Kyle Diamantas, the agency’s top food official, stepped in as acting commissioner. Biotech industry watchers said the sudden leadership change leaves uncertainty around which regulatory priorities and process reforms will carry forward. Several FDA functions involved in drug review and oversight are now handled by acting officials with limited time authority, tightening timelines for decisions and potentially contributing to turnover in senior roles. Prior to the exit, Makary had backed initiatives aimed at speeding drug development and rare disease pathways, including expanded voucher concepts and AI use in reviews—moves that industry will now be watching to see whether they persist.