Psychedelic Drugs: Considerations for Clinical Investigations; Guidance for Industry; Final Guidance
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- Title
- Psychedelic Drugs: Considerations for Clinical Investigations; Guidance for Industry; Final Guidance
- Posted
- Jul 14, 2026
- Comment period
- Jul 14, 2026 – ?
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Stance breakdown
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- Jul 17, 2026Comment from Leigh MessinidesOpposeIndividual
The commenter opposes the guidance's categorization of hallucinations as adverse events linked to abuse potential. They argue that this classification may be based on historical bias and suggest a broader definition of hallucinations that accounts for spiritual, artistic, and medical contexts.
Read comment → - Jul 15, 2026Comment from Randall SimpsonSupportIndividual
An individual provides feedback on the FDA's guidance for psychedelic drug clinical investigations, emphasizing the need for precise terminology regarding specific substances. The commenter also advocates for provider training that focuses on non-directive support, patient safety, and clear informed consent regarding the profound subjective effects of these drugs.
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