Psychedelic Drugs: Considerations for Clinical Investigations; Draft Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Psychedelic Drugs: Considerations for Clinical Investigations." Because interest in the therapeutic potential of psychedelic drugs has been increasing and designing clinical trials to evaluate these compounds presents unique challenges, FDA has developed this draft guidance to present foundational aspects for sponsors to consider. This draft guidance provides general considerations for sponsors developing psychedelic drugs for treatment of medical conditions (e.g., psychiatric disorders, substance use disorders) and discusses considerations for clinical investigations using psychedelic drugs.