Manatt Health June 28, 2023
On June 23, 2023, FDA issued a first-of-its-kind draft guidance for sponsors of studies of psychedelic drugs. The guidance arrived just as the Psychedelic Science 2023 conference in Denver was wrapping up. Touted as the “largest psychedelic conference in history,” the conference drew over 12,000 people, including an array of medical professionals, government officials (i.e., Dr. Joshua Gordon, Director of the National Institute of Mental Health (NIMH), and Commander Gene Gunn in FDA’s Office of Regulatory Affairs) and politicians (i.e., Colorado Governor Jared Polis and former Texas Governor Rick Perry). Additionally, recent activity on Capitol Hill demonstrates a growing interest by legislators in the field of psychedelic science. These events signal a significant shift in our cultural awareness and acceptance...
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