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New FDA Director Sparks Concerns Over Vaccine Policy Shift

12/4/2025

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Story summary
  • Tracy Beth Hoeg becomes acting director of Center for Drug Evaluation and Research (CDER) at U.S. FDA after Richard Pazdur's retirement.
  • Hoeg is described as a COVID vaccine skeptic who aims to modernize CDER amid vaccine policy shifts.
  • Theresa Michele has been reassigned after a decade leading the Office of Nonprescription Drugs, focusing on affordability.
  • Former FDA commissioners warn changes threaten transparency and signal a major shift in vaccine policy.