The news: The FDA appointed its long-time cancer therapy regulator Dr. Richard Pazdur as the new director of the Center for Drug Evaluation and Research (CDER). He has worked at the FDA for 26 years and has led oncology drug regulation since 2005.

Pazdur is the third drug director since President Trump took office. He replaces biotech industry executive George Tidmarsh who was named CDER director in July.

Why it matters: CDER oversees most prescription drug regulation, including reviews, approvals, and monitoring safety.

Pazdur is a respected FDA veteran whose leadership is expected to bring stability during a period marked by staff turnover, review delays, and shifting policies.

Implications for pharma: Pazdur’s appointment is likely to reassure drugmakers that have been concerned about regulatory changes and slower drug reviews and approvals. His long track record at the FDA and respected leadership signals a return to more predictable science-driven drug evaluation and oversight.

Pazdur is also known for championing the accelerated approval pathway for oncology drugs, which included Merck’s Keytruda immunotherapy now approved across 18 types of cancer. His priority access for promising therapies and removing them quickly when they proved unsafe or ineffective is a good sign more broadly for quicker but responsible times to market.

While consumers won’t recognize Pazdur or his rank at the FDA, they’ll benefit from the downstream effects of a more stable and consistent review process. A steady CDER means more trusted medications that are rigorously and fairly evaluated.

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