George Tidmarsh resigned as director of the FDA’s Center for Drug Evaluation and Research (CDER) after being placed on administrative leave amid an HHS investigation into his conduct. The department cited “serious concerns” tied to a LinkedIn post and related defamation claims; the leadership gap follows a string of recent departures at the center. The departures amplify regulatory uncertainty across drug reviews and industry interactions with the FDA. HHS statements and reporting by major outlets confirmed the resignation and the agency’s expectation of high ethical standards for senior officials. CDER’s principal deputy role remains vacant, complicating near‑term oversight of high‑profile submissions and policy initiatives. Companies with pending or imminent applications should expect additional engagement as the agency reallocates responsibilities. Industry stakeholders and litigants cited in related filings have already signaled potential courtroom and public relations fallout as the agency navigates internal reviews and external scrutiny.
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