Richard Pazdur, recently appointed head of the FDA’s Center for Drug Evaluation and Research (CDER), filed paperwork signaling his intent to retire at month-end, according to regulatory sources. The move comes weeks after his appointment and amid a broader leadership shakeup at the agency. Pazdur’s departure deepens uncertainty inside CDER as industry watches potential shifts in review priorities and policy directions. The exit follows internal controversies over vaccine and approval policies and coincides with other senior departures, amplifying concerns about regulatory continuity. Companies involved in late-stage submissions and those planning near-term interactions with CDER will likely reassess timelines and engagement strategies while the agency steadies its leadership ranks.
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