Can the CDER-CBER Dynamic Change Under New Leadership? Pazdur vs. Prasad in the FDA’s Turbulent 2025

Richard Pazdur, longtime director of the FDA’s Oncology Center of Excellence (OCE), was appointed as head of the Center for Drug Evaluation and Research (CDER) in November 2025 following the departure of George Tidmarsh amid controversy.1 2 3 10

Pazdur is recognized for his regulatory innovation, particularly in oncology, implementing expedited review programs and international collaborations such as Project Orbis.1 2 3

Vinay Prasad, a prominent FDA critic, was appointed (and briefly resigned from) the head of the Center for Biologics Evaluation and Research (CBER) earlier in 2025 amid external controversies; Prasad returned to the role following a period of instability.1 3 9

Leadership instability has affected both CDER and CBER, with multiple high-profile resignations and reappointments at the FDA, contributing to regulatory uncertainty and delay, especially in the biologics division.1 3 9

Pazdur’s appointment is broadly viewed as a stabilizing move, expected to restore confidence, streamline reviews, and reduce regulatory uncertainty, particularly in drug approvals.3 5 10

Despite often critical commentary from Prasad toward Pazdur’s earlier record, both now hold leadership over the FDA’s drug (CDER) and biologics (CBER) review centers, heightening attention on their approaches and their impact on the CDER-CBER dynamic.5 10

Analysts anticipate that Pazdur’s collaborative and reform-driven approach could set a new tone, potentially reducing friction between CDER and CBER and improving regulatory outcomes, but the full extent of changes depends on whether the agency can fill remaining leadership gaps with similarly capable figures.3 10

Recent leadership turbulence at the FDA stems from broader federal healthcare upheavals and has been exacerbated by actions and personnel decisions from Health Secretary Robert F. Kennedy Jr.1 3