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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.

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.

The FDA noted that a Reagan-Udall Foundation public meeting in the spring of 2023 — with FDA and the Substance Abuse and Mental Health Services Administration (SAMHSA) — and a December 2023 meeting with FDA, SAMHSA, and the National Institute on Drug…