Analysis of U.S. Food and Drug Administration Draft Guidance on Clinical Trials with Psychedelic Drugs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. Informed consent is recommended to include notice that subjects may experience changes in perception, cognition, and judgment that persist for many hours, as well as increased vulnerability and suggestibility during the treatment session.
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