Government Executive: How the FDA could shape the future of psychedelics research
FDA draft guidance posted in June 2023 provides a potential framework on how to overcome expectancy bias and the nocebo effect by employing an active placebo which could be a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.