• Veteran FDA leader Richard Pazdur, who recently took the helm of the Center for Drug Evaluation and Research (CDER), is reportedly preparing to depart the agency.
  • The potential exit, coming just months after his high-profile appointment, would mark a significant and unexpected leadership shift at a critical time for the drug review division.
  • The move, if confirmed, would add to a period of notable transition within the FDA's upper ranks, following the recent departure of his predecessor.

Dr. Richard Pazdur, the recently appointed director of the FDA's Center for Drug Evaluation and Research (CDER), is preparing to leave the agency, according to people familiar with the matter. The news comes as a surprise to many in the pharmaceutical and regulatory communities, given Pazdur's long tenure and his ascension to the top CDER role just last month.

Pazdur, who has spent 26 years at the FDA, was named to lead the powerful drug review center on November 11, 2025. He stepped into the position following the departure of his predecessor, George Tidmarsh, who left amid an investigation into his conduct. Pazdur was previously the founding director of the FDA's Oncology Center of Excellence, a role that earned him widespread recognition for accelerating the development of cancer therapies.

Details surrounding the timing and circumstances of his planned exit remain unclear. Efforts to reach Pazdur and the FDA for comment were not immediately successful. An agency spokesperson declined to comment on personnel matters.

His appointment to CDER was seen as a stabilizing move for the center, which oversees the approval of all new prescription drugs in the United States. The potential departure so soon after taking the role would create immediate uncertainty for the division's priorities and ongoing reviews. Industry executives, who had just begun adjusting to his leadership style, are now bracing for another transition at the top.

“This is highly unusual and disruptive,” said one biotech executive, who requested anonymity to discuss regulatory matters. “You don’t put someone in that seat expecting them to leave weeks later. It raises questions about what’s happening internally.”

The FDA has undergone several significant leadership changes in recent months. The search for a permanent replacement, should Pazdur depart, would be the next major task for the agency's commissioner. For now, the regulatory world is left waiting for official confirmation and an explanation for the abrupt change.