Industry sources and reporting indicate the FDA is experiencing a loss of experienced reviewers that executives and patient advocates say is degrading regulatory predictability and slowing drug development. Biopharma CEOs and investors flagged an exodus of staffers and institutional knowledge, which market participants say complicates review timelines and guidance. Separately, reporting highlighted an early clash between Commissioner-level appointees after Richard Pazdur’s appointment to lead the FDA’s drug center, with insiders describing disagreements over policy direction. Together the staffing gaps and leadership tensions raise immediate questions over the agency’s capacity to manage complex late‑stage reviews and policy shifts.