Top FDA drug regulator Richard Pazdur submitted paperwork to retire at month’s end, marking another abrupt leadership change at the agency’s drug center. The departure comes weeks after his appointment and amid broader turnover at senior FDA ranks, intensifying uncertainty over the regulator’s direction. Concurrently, the agency signaled it will appoint Tracy Beth Høeg as acting director of the Center for Drug Evaluation and Research (CDER). Høeg has been a prominent skeptic in COVID‑19 vaccine debates; her elevation to acting head is drawing attention from industry and public‑health stakeholders. The leadership shuffle arrives as the FDA negotiates user‑fee reauthorizations and advances policy proposals on preclinical testing and global trial fees. Companies say rapid turnover complicates long‑term regulatory strategy and may affect review timelines for high‑profile submissions.