Recent Staffing Changes at FDA Could Signal a Major Shift

By Rebecca Zadaka

Leadership Turnover at CDER: A Rapid Series of Departures

FDA has recently had a string staffing changes. Over the last few months, FDA has seen several staffing changes, particularly for the Center for Drug Evaluation and Research (CDER). From early November to early December, CDER has seen three director changes. Below is a summary of the recent staffing shifts and what this could mean for those who work with CDER.

Historically, CDER has not seen much turnover in leadership, but in 2025 alone, there have been several different heads of CDER. In January, Patricia Cavazzoni left FDA for another position, and Jacqueline Corrigan-Curay took over on an acting basis until her retirement in July.

George Tidmarsh was then appointed head of CDER. But this was short lived, as he resigned in early November.

Next was Richard Pazdur. After taking the post as head of CDER in early November, he resigned just weeks later. 

On December 3, FDA announced that Tracy Beth Høeg had been appointed as the acting director of CDER. Commissioner Marty Makary said, “Dr. Høeg is the right scientist to fully modernize CDER and finish the job of establishing a culture of cross-center coordination there.”

Broader Leadership Shifts across FDA

Also on December 3, as part of FDA’s “modernization implementation,” it also announced a new leader of its Office of Nonprescription Drugs (ONPD), Karen Murry, M.D. This announcement also noted that longtime ONPD director, Theresa Michele, transitioned to a leadership position in the FDA’s medical device center.

Separately, in spring 2025, leadership changes occurred within the Center for Biologics Evaluation and Research (CBER), where Vinay Prasad assumed the role of Center Director following the conclusion of Peter Marks’ tenure.

“Periods of leadership transition increase the importance of disciplined planning. Companies must understand not only the regulations, but how changes at the agency level can influence timelines, expectations, and strategic choices.”
– Rebecca Zadaka, Associate Attorney

Taken together, these developments reflect a period of organizational change across multiple FDA centers. Consistency in leadership and regulatory expectations plays an important role in supporting predictability for industry. During these times of transition, companies may experience shifts in communication cadence, evolving emphasis on particular policy areas, or changes in how issues are escalated and resolved.

From a practical standpoint, leadership changes can affect how priorities are set, how modernization initiatives progress, and how guidance or policy interpretations are operationalized. Even when day-to-day review teams remain stable, shifts at the center level may influence how scientific disputes are resolved, how policy questions are escalated, or how new regulatory frameworks are implemented.

For organizations preparing submissions or managing active interactions with CDER or other FDA center[ND1] s, the focus should remain on ensuring continuity of strategy. Clear documentation, consistent messaging, and proactive engagement can help mitigate uncertainty and support informed planning for product development programs, trial design, labeling strategy, or lifecycle management decisions.

How Gardner Law Can Help

Organizations interacting with CDER or other FDA centers should be prepared for variability during leadership transitions, particularly in areas where policy is evolving or where scientific questions require higher-level escalation. Even when review staff remain consistent, changes in center leadership can influence how emerging issues are prioritized, how risk–benefit considerations are framed, and how quickly policy positions are clarified.

Our team monitors these developments in real time and evaluates how they may affect application strategy, meeting preparation, communications with review divisions, and long-term regulatory planning. We assist clients in:

• Identifying points in the development or review process that are most susceptible to delay or shifting expectations
• Preparing robust documentation, regulatory position statements, and briefing materials that withstand variability in scientific or policy interpretation
• Structuring interactions with FDA to maintain momentum and reduce the likelihood of misalignment or rework
• Planning for downstream implications, including labeling strategy, postmarket commitments, and lifecycle considerations

In periods of agency instability, predictable progress depends on proactive preparation and disciplined regulatory execution. Gardner Law helps companies navigate these uncertainties and maintain the clarity, responsiveness, and strategic readiness necessary to keep programs moving forward. To discuss how these changes may affect your organization and how we can help, contact Gardner Law.