Rick Pazdur to lead CDER, FDA speaker says, pledging cross-center alignment

A participant in an informal FDA roundtable said Rick Pazdur will "step up to take over CDER," and described plans to create greater alignment between the agency’s centers for biologics and drugs. The speaker praised Pazdur’s quarter-century career in oncology and said the move seeks to reduce what they described as prior "territorial" inconsistencies between the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

The speaker said OCE (the Oncology Center of Excellence), which Pazdur has run, has for years pursued practices—such as seamless trial designs and use of validated surrogate endpoints—that could serve as models across other therapeutic areas. To institutionalize that, the speaker said Pazdur proposed forming similar cross-center teams in cardiology, nephrology and rare diseases so sponsors encounter more consistent expectations regardless of whether a product is reviewed as a biologic or a small molecule.

According to the speaker, that consistency should reduce idle time in multi-step reviews and speed decisions without increasing individual reviewers’ workloads. The speaker framed the change as beneficial for patients and industry and said they will work with Pazdur to implement the approach.

The speaker did not provide a formal personnel announcement packet or a target date for any leadership transition. They said the idea emerged from recent listening sessions and that more details and public announcements are expected in the coming weeks.