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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…

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.

Members of the consortium have had an ongoing dialogue with the hub, Critical Path Institute, the Reagan-Udall Foundation, and AMP ALS since mid-2024.

In anticipation of the 2025 Strategic Agenda, the Reagan-Udall Foundation and the FDA co-hosted a stakeholder meeting where the FDA received input on what the Hub should prioritize. Dr. Flores represented BIO in the October 2024 meeting.

On the FDA’s behalf, the Reagan-Udall Foundation has held roundtables with industry members to share insights, identify and prioritize key issues, and explore implementation strategies.