Breaking News: FDA Announces New CDER Leadership
The U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) have jointly announced the appointment of Richard Pazdur, M.D., as the new director of the Center for Drug Evaluation and Research (CDER). This strategic leadership decision marks a significant milestone in the agency’s ongoing efforts to modernize pharmaceutical regulation and streamline drug approval processes.
FDA Commissioner Marty Makary, M.D., M.P.H., praised the appointment, stating, “Dr. Pazdur is a true regulatory innovator who will help guide our broader agenda to modernize the agency and streamline the approval process. He has a track record of success and is an impressive forward-thinking scientist.”
Transition from Oncology Center of Excellence
Dr. Pazdur will continue serving as director of the Oncology Center of Excellence until a suitable successor is identified and appointed. This dual responsibility ensures continuity in the FDA’s oncology oversight during the leadership transition period.
Who is Richard Pazdur?
Dr. Richard Pazdur brings an impressive 26-year tenure at the FDA, where he has established himself as a pioneering force in pharmaceutical regulation, particularly in oncology drug development and approval processes.
Career Before the FDA
Before joining the FDA, Dr. Pazdur served as a professor of medicine at The University of Texas M.D. Anderson Cancer Center in Houston, Texas, one of the nation’s premier cancer treatment and research institutions. This clinical experience provided him with invaluable insights into the practical challenges facing cancer patients and oncology professionals.
Dr. Pazdur’s Transformative Work in Oncology
Throughout his distinguished career at the FDA, Dr. Pazdur developed an integrated, cross-center coordination approach for oncology product review. This innovative framework has significantly expedited the development and approval of novel cancer therapies, directly benefiting patients who urgently need access to life-saving treatments.
His leadership catalyzed the launch of multiple groundbreaking initiatives designed to streamline oncology drug approvals while maintaining rigorous safety standards. These efforts have positioned the FDA as a global leader in regulatory innovation for cancer treatments.
Innovative Projects Led by Dr. Pazdur
Dr. Pazdur spearheaded several transformative projects that have reshaped oncology drug regulation:
Project Orbis
This initiative established a framework for concurrent submission and review of oncology products among international regulatory partners. Project Orbis enables patients worldwide to gain faster access to promising cancer treatments by facilitating simultaneous review across multiple countries.
Project Facilitate
Recognizing the critical importance of expanded access for cancer patients, Dr. Pazdur developed Project Facilitate to support oncology professionals in completing expanded access requests. This program helps terminally ill patients access investigational drugs before formal approval.
Project Renewal
This comprehensive effort focused on updating prescription information for older oncology drugs, ensuring that healthcare providers and patients have access to clinically meaningful and scientifically current information. Project Renewal demonstrates Dr. Pazdur’s commitment to continuous improvement in pharmaceutical regulation.
Educational Background and Publications
Dr. Pazdur’s academic credentials are equally impressive. He earned his bachelor’s degree from Northwestern University and his M.D. from Loyola Stritch School of Medicine. His clinical training was completed at Rush-Presbyterian St. Luke’s Medical Center and the University of Chicago Hospitals and Clinics.
Scholarly Contributions
Beyond his regulatory work, Dr. Pazdur has made substantial contributions to medical literature, authoring over 800 articles, book chapters, and abstracts. He has also written two medical oncology textbooks, cementing his status as both a regulatory leader and respected academic authority.
Dr. Pazdur’s Vision for CDER
Regarding his new appointment, Dr. Pazdur expressed enthusiasm about the opportunity: “I’m honored to lead CDER at a time when the FDA is achieving long-sought regulatory reforms. 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.”
This statement underscores Dr. Pazdur’s commitment to advancing the FDA’s modernization agenda while maintaining the agency’s gold-standard safety and efficacy requirements.
Context of FDA Leadership Changes
Dr. Pazdur’s appointment occurs during a period of significant transition within the FDA. Throughout 2025, the agency has experienced considerable turnover among senior leadership positions, including the departure of George Tidmarsh, the former head of the Center for Biologics Evaluation and Research (CBER).
Recent Organizational Changes
On Friday, October 31, the FDA announced that Tidmarsh had been placed on administrative leave. According to ABC News, Tidmarsh was contemplating resignation at that time, citing what he characterized as a “toxic environment” at the agency.
Conflicting reports emerged regarding the circumstances of Tidmarsh’s removal. However, according to ABC News, Tidmarsh himself attributed his departure to criticism he voiced regarding Vinay Prasad, chief medical and scientific officer at the FDA, as well as concerns about new regulatory processes designed to accelerate the approval timeline.
What This Means for Drug Development
Dr. Pazdur’s appointment signals the FDA’s commitment to regulatory innovation and efficient drug development processes. His proven track record in oncology regulation, combined with his collaborative approach and scientific expertise, positions him ideally to lead CDER during this transformative period.
The pharmaceutical industry, patient advocacy groups, and healthcare professionals will be watching closely as Dr. Pazdur implements his vision for modernizing drug evaluation and research at America’s premier regulatory agency.
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