What Richard Pazdur’s New Role Means for FDA Drug Reviews—and How It Might Shape Biotech

A new drug division chief is in charge at the Food and Drug Administration (FDA), and his appointment may help steady the turbulence that the agency has experienced this year under the Trump administration.

On Nov. 11, the Department of Health and Human Services named Richard Pazdur, MD, a 26-year agency veteran and founding director of the Oncology Center of Excellence, as director of the Center for Drug Evaluation and Research (CDER). The move comes less than two weeks after former CDER director George Tidmarsh, MD, PhD, resigned following a lawsuit from a former associate and an inspector general probe.

CDER is the office that oversees most prescription drugs and many biologics, so the leadership change will touch almost every biotech startup with ambitions to bring a product to market. In its announcement, the FDA highlighted Pazdur’s role in building cross-center oncology review and launching initiatives such as Project Orbis, which coordinates cancer drug reviews with regulators in other countries.

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

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The Industry Is Reacting

During his time at the FDA, Pazdur has approved hundreds of oncology therapies while pushing drug developers toward faster but more structured development plans. Industry groups praised the move.

“Dr. Pazdur has a strong track record of regulatory leadership and commitment to the needs of patients, and his appointment is a positive step for biomedical research,” a spokesperson for the biotech advocacy group Biotechnology Innovation Organization (BIO) said in a statement sent to Cure.

“Rick Pazdur has been a tireless public servant and one of the most trusted leaders in biomedical innovation,” said Ellen Sigal, Chair & Founder, Friends of Cancer Research, in a statement. “At a time when the agency faces both extraordinary opportunity and complexity, Rick’s steady leadership and commitment to scientific integrity make him exactly the right person to lead CDER.”

Across social media, various life science investors, executives, patient advocates, and scientists posted positive reactions to Pazdur’s appointment.

Rod Wong, MD, founder and CIO of life sciences investment firm RTW Investments, wrote on X (formerly Twitter) that the appointment of Pazdur was a “terrific idea.”

“(H)e is experienced and competent, and has a reputation for rigor while understanding patients’ need to move fast. issue now is [CBER], where emerging technologies for orphan diseases needs to be turned around.”

Pazdur’s Record Signals New Standards for the FDA

Pazdur created Project Orbis in 2019 to speed drug approvals across multiple countries simultaneously. The program allows the FDA to review applications alongside regulators in Canada, Australia, Brazil, the United Kingdom, Israel, Switzerland, and Singapore. To date, 633 applications for 79 products have gone through the program.

"Approximately 20% of the participants in these large multi-regional oncology trials are enrolled in the United States," Pazdur said in a July interview with the FDA's Office of Global Policy and Strategy. "The U.S. has a heterogeneous population and a sophisticated medical delivery system, and we need to have confidence that the data are generalizable to our population and medical practice."

His approach has typically favored faster timelines paired with stronger evidence standards, pushing companies toward well-designed trials that generate clear patient benefit—a signal biotech startups will need to prepare for.

Academic Background

Before joining the FDA, Pazdur was professor of medicine at The University of Texas M.D. Anderson Cancer Center in Houston. He has published more than 800 articles, abstracts, book titles, and two medical textbooks on cancer.

"I'm honored to lead CDER at a time when the FDA is achieving long-sought regulatory reforms," Pazdur said in the FDA news release. "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."