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GUIDANCE DOCUMENT

Psychedelic Drugs: Considerations for Clinical Investigations June 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Submit Comments Online

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-1987

Docket Number:
FDA-2023-D-1987
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The U.S. Food and Drug Administration (FDA or Agency) is issuing this guidance to provide general considerations to sponsors developing psychedelic drugs for treatment of medical conditions (e.g., psychiatric disorders, substance use disorders). For the purposes of this guidance, the term psychedelic is used as shorthand to include classic psychedelics, typically understood to be 5-HT2 agonists such as psilocybin and lysergic acid diethylamide (LSD), as well as entactogens or empathogens such as methylenedioxymethamphetamine (MDMA).

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