Analysis of U.S. Food and Drug Administration Draft Guidance on Clinical Trials with Psychedelic Drugs
Healthcare Law Insights blog
JUNE 30, 2023
On June 23, 2023 the U.S. FDA recommends referring to its 2017 guidance “Assessment of Abuse Potential of Drugs” for details. All comments should be identified with the docket number FDA-2023-D-1987. FDA also recommends characterizing the dose-response relationship, as this is poorly understood for most psychedelic drugs.
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