Richard Pazdur, director of the FDA’s Center for Drug Evaluation and Research (CDER), has filed paperwork to retire at month’s end, creating immediate uncertainty at the agency’s drug-review helm. Multiple reports indicate Pazdur initiated his departure weeks after being elevated to the post, a move that follows a turbulent year of leadership changes at the FDA. Industry participants and regulatory watchers say the timing could affect ongoing high-stakes reviews and internal reform efforts at CDER. A separate report corroborates Pazdur’s intent to step down and notes he could retract the paperwork, but for now FDA leadership faces another near-term transition. The departures add operational risk for sponsors preparing late-stage submissions and for teams engaged in diagnostics and biologics reviews, where continuity in scientific leadership frequently shapes regulatory strategy. Market actors should expect a near-term focus on interim management and potential delays in discretionary policy initiatives. Companies with upcoming or active regulatory interactions should consider proactive outreach to the agency and contingency planning for timing-sensitive filings.