On Monday, the FDA announced that it will hold a public meeting on October 16, 2024, titled, “Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub.”

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According to findings by the Reagan Udall Foundation, that is exactly what is happening as stakeholders navigating the process “expressed concerns about a lack of clarity, transparency, and communication” regarding the CTP’s priorities and decision-making processes.

FDA draft guidance posted in June 2023 provides a potential framework on how to overcome expectancy bias and the nocebo effect by employing an active placebo which could be a substance that also has mind-altering effects but no expected therapeutic benefit. This was reiterated during a virtual public meeting, “Advancing Psychedelic Clinical Study Design,” organized by the Reagan-Udall Foundation for the FDA in the winter of 2024.

In April, FDA resumed the posting of regulatory science policy memos, with a subsequent release in May. The release of these latest memos reflects the CTP’s ongoing commitment to enhance transparency consistent with the December 2022 evaluation of the center by an independent expert panel facilitated by the Reagan-Udall Foundation.

In January 2023, the FDA announced it would develop a reorganization proposal to create a unified Human Foods Program and restructure its field operations (Office of Regulatory Affairs) after carefully reviewing the findings and recommendations of an outside evaluation by the Reagan-Udall Foundation.

Jones spent 30 years working at the U.S. Environmental Protection Agency, primarily as a pesticide regulator, and served on the Reagan-Udall Foundation’s Independent Expert Panel for Foods, which submitted a report on the operational evaluation of the FDA’s Human Foods Program to the agency in December 2022 — experiences that have prepared him for the new FDA role.

The paper, titled "In Silico Technologies: A Strategic Imperative for Accelerating Breakthroughs and Market Leadership for FDA-Regulated Products," has been published online by Regulatory Science Accelerator (RSA), a platform developed by the Reagan-Udall Foundation in partnership with FDA Chief Scientist's Office of Regulatory Science and Innovation.

Among other recommendations, the NSAEM report reiterates other sentiments expressed by FDA and the Reagan-Udall Foundation, as well as consumer advocacy groups; specifically, that FDA’s authority to oversee manufacturing significantly hindered the agency’s ability to facilitate an effective response or to prevent the shortage that occurred.

In September 2022, per the request of the FDA Commissioner, Dr. Robert Califf, an independent expert panel facilitated by the Reagan-Udall Foundation began an operational evaluation of the agency’s Center for Tobacco Products (CTP).

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In collaboration with the US Food and Drug Administration (FDA), the Reagan-Udall Foundation for the FDA, is today hosting a hybrid public workshop on "Understanding Current Use of Ketamine for Emerging Areas of Therapeutic Interest."

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