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FDA names Dr Richard Pazdur to replace George Tidmarsh as CDER Director

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The FDA-veteran and oncology specialist will lead the US drug agency’s work ensuring the safety and efficacy of medicines.

US FDA CDER Dr Richard Pazdur

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) has appointed 26-year agency veteran Dr Richard Pazdur as its new director.

 

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The internal hire will see Dr Pazdur remain in his current role as the FDA’s director of the Oncology Center of Excellence until a successor is appointed.

He takes over from George Tidmarsh, who resigned earlier this month after just a few weeks in the role when questions were raised over his personal conduct.

In Dr Pazdur’s decades-long tenure at the FDA, he founded FDA’s Oncology Center of Excellence as its director, of which he will remain in post until a successor is chosen. His contribution includes developing an approach to expedite novel cancer therapy development via enabling cross-centre coordination of oncology product review. Additionally, he led the launch of multiple initiatives to streamline oncology drug approvals, access and labelling.

FDA Commissioner Marty Makary said: “Dr Pazdur is a true regulatory innovator who will help guide our broader agenda to modernise the agency and streamline the approval process. He has a track record of success and is an impressive forward-thinking scientist.”

Dr Pazdur is a true regulatory innovator who will help guide our broader agenda to modernise the agency and streamline the approval process. He has a track record of success and is an impressive forward-thinking scientist”

With the US administration experiencing instability via mass layoffs in recent months, alongside Vinay Prasad’s abrupt return as head of vaccines and cell and gene therapy at the FDA’s Center For Biologics Evaluation and Research (CBER), following his resignation in August only weeks earlier, the FDA’s new hire brings renewed optimism.

Dr Pazdur previously held the role of professor of medicine at The University of Texas MD Anderson Cancer Center in Houston, Texas. He received his bachelor’s degree from Northwestern University, his MD from Loyola Stritch School of Medicine, and trained at Rush-Presbyterian St. Luke’s Medical Center and the University of Chicago Hospitals and Clinics. He has published over 800 articles, book chapters, and abstracts, as well as two medical oncology textbooks.

“I’m honoured to lead CDER at a time when the FDA is achieving long-sought regulatory reforms,” said Dr Pazdur. “I look forward to working closely with Dr Makary and the medical experts he’s assembled to help our country reach its peak in drug development.”

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