The FDA is undergoing rapid leadership change: Richard Pazdur filed to retire as director of the agency’s drug center, and the FDA named Tracy Beth Høeg as acting director of the Center for Drug Evaluation and Research (CDER). Both developments were disclosed this week and follow broader staffing turnover at the agency. Pazdur’s planned departure comes less than a month after he assumed the role; the move adds to uncertainty about regulatory continuity for drug reviews. The appointment of Dr. Høeg, a physician who gained visibility during recent vaccine safety work, places a new acting leader at CDER as the agency handles multiple high‑profile drug applications and policy negotiations. Industry groups, trial sponsors, and investors are watching how the transition will affect review timelines, enforcement priorities, and PDUFA reauthorization talks. The FDA has signaled interim management plans while senior appointments are finalized.