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“The Supreme Court’s decision elevates the importance of the Reagan-Udall Foundation’s findings after being convened at the request of the FDA commissioner, which specifically and clearly criticized the FDA’s Center for Tobacco Products for failing to…

The meeting, which will be facilitated by the Reagan-Udall Foundation, will provide those in the rare disease community the opportunity to provide input on the priorities of the hub. The FDA plans for the hub to work across rare diseases but especially…

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.” Read more

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-…

FDA draft guidance posted in June 2023 provides a potential framework on how to overcome expectancy bias and the nocebo effect by employing an active placebo which could be a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…

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…

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…

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…

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-…

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…