The HHS announced that acting leaders at the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) will become permanent, aiming to restore leadership continuity as the agency awaits a potential FDA commissioner confirmation. Michael Davis and Karim Mikhail were promoted from acting to permanent division heads, while Jared Seehafer will serve as the FDA’s first Deputy Commissioner for Technology and Artificial Intelligence. The move follows a period of division-head departures and “caretaker mode,” according to analysts cited in coverage. In parallel, the FDA is still tracking the commissioner nomination process for Heidi Overton, which could affect how duties are delegated across divisions. RBC Capital Markets described the promotions as a stabilizing signal for policy continuity. The announcement underscores how governance and resourcing at the FDA—especially for biologics and AI-related review modernization—are becoming immediate execution factors for biotech development timelines.
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