George Tidmarsh, director of the FDA’s Center for Drug Evaluation and Research (CDER), has been placed on administrative leave, according to multiple reports. Tidmarsh leads the agency office that reviews new drugs and biologics, and his sudden removal was reported by national outlets citing internal sources. The move follows accounts that Tidmarsh had raised concerns about agency decision-making. The action is already prompting scrutiny from industry stakeholders who rely on predictable regulatory review timelines. Sources reporting the leave include news outlets with inside-agency contacts; the FDA has not published a full public account of the personnel action. For companies with late-stage programs under CDER review, changes at the top of the drugs office raise questions about consistency in application assessments and potential delays in key approvals.
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