The FDA appointed long‑time oncology regulator Richard Pazdur as director of the Center for Drug Evaluation and Research (CDER), a move framed by agency leaders as restoring experienced, science‑driven leadership. Pazdur’s track record includes expedited cancer approvals and post‑market enforcement actions. At the same time, PDUFA VIII negotiations began with the FDA pressing an “America First” approach to regulatory policy and user‑fee design, signaling potential shifts in negotiation priorities affecting industry timelines and domestic manufacturing incentives. The tandem developments—leadership change and PDUFA policy talks—are likely to influence sponsor interactions with CDER on accelerated approvals, evidentiary expectations, and lifecycle management for high‑impact therapeutics.