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FDA draft guidance posted in June 2023 provides a potential framework on how to overcome expectancy bias and the nocebo effect by employing an active placebo which could be a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