The Trump administration moved three acting FDA center heads into permanent leadership roles, stabilizing key review functions across drugs and biologics. The FDA named Michael Davis to lead CDER, Karim Mikhail to lead CBER, and Bret Koplow to lead the Center for Tobacco Products, following prior acting assignments. The change also included the FDA’s first Deputy Commissioner for Technology and Artificial Intelligence, Jared Seehafer, signaling continued agency focus on AI-enabled review workflows as leadership roles consolidate. The appointments arrive ahead of a commissioner confirmation pipeline that remains underway. For biotech, the immediate impact is continuity of scientific and regulatory decision-making in product areas governed by CDER and CBER, including oncology small molecules, biologics, vaccines, gene therapies, and advanced modalities. The AI deputy role adds a structural emphasis on how evidence packages and review operations may be processed going forward.