Analysis of U.S. Food and Drug Administration Draft Guidance on Clinical Trials with Psychedelic Drugs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. Clinical safety reporting should track all abuse-related adverse events (AEs), such as euphoria, hallucinations, stimulation, and emotional lability. All comments should be identified with the docket number FDA-2023-D-1987. Comments can be submitted to Regulations.gov.
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