Dr. Richard Pazdur Named Director of FDA’s CDER as Novartis Plans Radioligand Facility in California

Dr. Richard Pazdur has been appointed as the new director of the FDA’s Center for Drug Evaluation and Research (CDER), marking a significant leadership change in the agency’s drug evaluation division. Hospitals have expressed opposition to the government’s 340B pilot program, citing concerns over its impact on healthcare operations. Meanwhile, Novartis is expanding its manufacturing presence in the United States with plans to open a radioligand therapy facility in California.

Pazdur’s appointment is expected to influence how the FDA approaches drug evaluation and approval processes moving forward. The 340B pilot program, designed to test new methods for managing discounted drug pricing for hospitals serving low-income patients, has faced resistance from healthcare providers who argue it could disrupt existing systems. In addition, Novartis’ investment in a new facility reflects ongoing efforts by pharmaceutical companies to bolster domestic production capabilities, particularly in advanced therapies like radioligand treatments. These developments highlight key shifts within regulatory frameworks, hospital systems, and industry expansion initiatives.

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Date: November 13, 2025

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