Analysis of U.S. Food and Drug Administration Draft Guidance on Clinical Trials with Psychedelic Drugs
Healthcare Law Insights blog
JUNE 30, 2023
FDA recommends referring to its 2017 guidance “Assessment of Abuse Potential of Drugs” for details. Clinical FDA believes that the characteristics of psychedelic drugs present challenges in designing adequate and well-controlled (AWC) clinical studies. For one, the use of an inert placebo may present a challenge.
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