FDA draft guidance posted in June 2023 provides a potential framework on how to overcome expectancy bias and the nocebo effect by employing an active placebo which could be a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