George Tidmarsh, the director of the FDA’s Center for Drug Evaluation and Research (CDER), resigned following reports of administrative leave and a Health and Human Services probe into his conduct. The agency cited an investigation by its Office of the General Counsel and the Office of Inspector General; Tidmarsh’s exit deepens uncertainty at the FDA’s crucial drug‑review center amid recent turnover and high‑profile controversies. The sudden leadership vacuum at CDER has immediate operational implications: review priorities, meeting schedules with sponsors, and regulatory policy initiatives now face disruption. Industry stakeholders cite greater unpredictability for submissions and clarifying communications with the agency. Observers will track interim leadership moves and whether the department’s inquiry prompts broader changes to CDER governance and staff morale.
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