The US Food and Drug Administration (FDA) has a new chief drug regulator, with industry veteran Dr Richard Pazdur taking the helm amid a period of senior leadership instability at the agency.
Pazdur, who currently leads the FDA’s Oncology Center of Excellence (OCE), will head up the Center for Drug Evaluation and Research (CDER).
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CDER’s previous director, George Tidmarsh, resigned earlier this month after concerns were raised about his conduct.
By appointing Pazdur, the FDA has turned to a regulatory veteran who has been with the administration for 26 years. Pazdur is known for implementing several initiatives to expedite oncology drug approvals. For example, Pazdur is a founding director of OCE, a body that brings together experts to streamline cancer therapy development and reviews. He will continue to serve as director of OCE until a successor is named.
Pazdur is also credited with Project Orbis – an international collaborative programme established by the FDA that allows regulatory authorities from international partners to concurrently review and approve promising new cancer treatments.
The new CDER head, who was previously professor of medicine at The University of Texas M.D. Anderson Cancer Center, also led launches of other FDA projects that help support expanded access and update prescribing information for older drugs.
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By GlobalDataFDA 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.”
In a statement, Pazdur said: “I’m honoured 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.”
The FDA harnessing a seasoned regulator with expertise in streamlining processes aligns with a wider agency goal to speed up timelines for certain treatments. For example, in June 2025, the FDA created a new priority review voucher (PRV) framework to expedite the drug approval process for pharma companies prioritising US interests. The new scheme, called the Commissioner’s National Priority Voucher (CNPV) programme, will shorten FDA review time for a new drug application from between 10 and 12 months to up to two months.
US healthcare’s revolving door of leaders
However, Pazdur’s appointment comes at a time of instability at several US healthcare regulatory bodies. Even before Tidmarsh’s controversial exit, there were multiple changes in senior leadership positions at the FDA and other agencies.
Peter Marks resigned as the FDA’s Center for Biologics Evaluation and Research (CBER) in March 2025, a role he held from 2016. Marks stated that US Health Secretary Robert F Kennedy (RFK) Jr favoured “misinformation and lies”.
Just three months later, the FDA’s cell and gene therapy office director, Nicole Verdun, was placed on administrative leave in June. Both Marks and Verdun were well-respected regulators by industry and academic experts.
Another prominent axing came in the form of Centers for Disease Control and Prevention (CDC) director Susan Monarez, who was fired just 28 days into her post. This came amid a disagreement with RFK Jr on US vaccine strategy.
Even those aligned with RFK Jr have found themselves on the chopping block. On 29 July, Vinay Prasad stepped down from his role as head of CBER. It has since emerged that his exit was amid a slew of social media attacks against him from controversial conservative activists. In a U-turn that caught many in the industry off guard, Prasad reassumed his role at the agency in August.
