Issue Date: July 14, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Medical
Status: Final
Psychedelic Drugs: Considerations for Clinical Investigations
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled “Psychedelic Drugs: Considerations for Clinical Investigations.” Because interest in the therapeutic potential of psychedelic drugs has been increasing and designing clinical trials to evaluate these compounds presents unique challenges, FDA developed the draft guidance to present foundational aspects for sponsors to consider. This final guidance provides general considerations for sponsors developing psychedelic drugs for the treatment of medical conditions (e.g., psychiatric disorders, substance use disorders) and discusses recommendations for clinical investigations using psychedelic drugs. This guidance finalizes the draft guidance of the same title issued on June 26, 2023.
Download the Guidance Document
