The U.S. Food and Drug Administration (FDA) has named Dr. Richard Pazdur, a longtime regulator and cancer specialist, as the new director of its Center for Drug Evaluation and Research (CDER) — the agency’s largest division — following the abrupt departure of its previous chief amid an ethics probe.

Pazdur, who has served at the FDA for 26 years, previously headed the agency’s Oncology Center of Excellence and played a key role in speeding up approvals of cancer therapies. He will now lead the unit responsible for reviewing and ensuring the safety and quality of both prescription and over-the-counter drugs.

His appointment comes just over a week after Dr. George Tidmarsh resigned as CDER director following a government ethics review into “serious concerns about his personal conduct.” Tidmarsh, a former pharmaceutical executive, had been appointed by FDA Commissioner Marty Makary.

A lawsuit filed earlier this month accused Tidmarsh of using his FDA position to pursue a “personal vendetta” against the chairman of a Canadian drug company where he once worked. Tidmarsh has denied the allegations but has not responded to recent requests for comment.

Pazdur’s promotion comes as the agency faces internal turmoil after a series of retirements, dismissals and resignations under the Trump administration, which have left morale low and staffing depleted. The FDA’s drug center has lost more than 1,000 employees over the past year due to layoffs and resignations, according to agency figures.

Pazdur is expected to bring stability and continuity to the agency’s leadership amid ongoing tensions between CDER and other FDA branches, including the vaccine and biologics division led by Dr. Vinay Prasad.

He will also oversee several new initiatives introduced by Commissioner Makary, such as a voucher program designed to fast-track reviews of drugs deemed a “national priority” within one to two months — a significant acceleration from the FDA’s previous six-month expedited review process.

As the FDA’s top cancer regulator, Pazdur has been credited with reshaping cancer drug approvals by allowing the use of early indicators like tumor shrinkage to speed access to new treatments. That policy has drawn criticism from some academic experts, including Prasad, who previously questioned the agency’s leniency toward cancer drug approvals before joining the FDA earlier this year.

Source: AP