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FDA Issues Draft Guidance for Psychedelic Research

The draft provides researchers with considerations for designing clinical trials, emphasizing safety and participant selection criteria.

Screenshot 2023 06 26 At 10 04 45 Pm
Cottonbro Studio

According to a recent Marijuana Moment article, the FDA has released its first-ever draft guidance for conducting research on psychedelic substances. The move comes just days after a group of congressional lawmakers filed a bill urging the FDA to do so. The draft guidance is intended to assist researchers in designing clinical trials to explore the therapeutic potential of psychedelic drugs, including substances like psilocybin and MDMA.

The FDA's draft guidance outlines key considerations for researchers, including study design, safety measures, and protocols for obtaining and manufacturing psychedelic substances for clinical trials. The guidance emphasizes the need for safety evaluations, study protocols, and participant selection criteria. It also highlights the importance of addressing potential risks associated with the use of psychedelics, such as psychological effects and adverse events.

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