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In addition to the new AACR award, Dr. Pazdur has received numerous awards and honors throughout his career: the Regulatory Affairs Professionals Society Patient-Centered Health Award (2021), the University of Chicago Cancer Research Foundation Simon M…

In 2022, the FDA requested the Reagan Udall Foundation conduct an independent investigation of the CTP. The resulting report highlighted several shortcomings, including a lack of a clear regulatory and product approval framework, an inefficient and slow…

Regulatory agencies need access to external experts in order to improve regulatory processes, scan the horizon for emerging technologies, and engage with the public, among other activities. Government-affiliated foundations provide a flexible and…

The FDA’s recent reorganization illustrates the value of transparency—radical or otherwise—to industry and consumers alike. In the wake of an infant formula crisis that justifiably incensed the public and lawmakers, the agency relied on extensive…

In October 2024, after two years of planning and Congressional review and approval, a major restructuring took effect at FDA, establishing a new Human Foods Program and Office of Inspections and Investigations. The reorganization was informed by an…

The failures of the CTP are well-documented. In 2022, an independent review by the Reagan-Udall Foundation found that the agency was in disarray, manipulated by outside interests rather than driven by scientific evidence.

A 2022 report by the Reagan-Udall Foundation concluded that the CTP had failed in its primary role as a product regulator.

On 4 September 2024, the Reagan-Udall Foundation for the FDA (FDA Foundation) in collaboration with the Food and Drug Administration (FDA) and the Gates Foundation hosted a workshop titled “Scientific Advancements in Gene Therapies: Opportunities for…

A December 2022 report by the Reagan-Udall Foundation found the CTP had failed in its primary mission to regulate.

Importantly, on October 1, 2024, the FDA implemented a long-planned reorganization of the Human Foods Program and the FDA field operations in response to the Reagan-Udall Foundation Evaluation published in 2022.