Lead federal drug regulator Richard Pazdur has submitted retirement papers and plans to leave the Food and Drug Administration at the end of the month, according to two agency sources familiar with the decision.
STAT reported that sources said Pazdur notified senior officials at the FDA's drug center during a Tuesday meeting, though he could still withdraw the paperwork.
He accepted the position at the request of FDA Commissioner Marty Makary.
Pazdur was appointed in mid-November to lead the Food and Drug Administration's Center for Drug Evaluation and Research, a move that placed the longtime regulator at the head of the agency's primary drug oversight division.
The Department of Health and Human Services and the FDA announced the appointment on Nov. 11, describing Pazdur as a central figure in the agency's modern drug review efforts.
Pazdur, who founded the FDA's Oncology Center of Excellence, was elevated to the CDER post as part of Makary's effort to reshape the agency's regulatory structure.
Makary said Pazdur is a regulatory innovator who would help advance a broader agenda to modernize and streamline the approval process.
Pazdur said at the time he was honored to take the role and looked forward to working with Makary and the team of medical experts brought into the agency.
The plan was for Pazdur to remain director of the Oncology Center of Excellence until a successor was chosen.
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