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# Draft Guide on Medical Psychedelic Drugs
- URL: https://www.fdaweb.com/draft-guide-on-medical-psychedelic-drugs/
- Published: 2023-06-23T12:00:00.000Z
- Updated: 2026-09-14T18:40:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154752

FDA has posted a [draft guidance](https://www.fda.gov/media/169694/download?ref=fdaweb.com) entitled “Psychedelic Drugs: Considerations for Clinical Investigations.” The document provides general considerations to sponsors developing psychedelic drugs for treating such medical conditions as psychiatric and substance use disorders. Under the 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),” the guidance says.

The document also describes basic considerations such as trial conduct, data collection, subject safety and NDA requirements. “For example,” FDA says, “psychedelic drugs may produce psychoactive effects such as mood and cognitive changes, as well as hallucinations. As a result, there is the potential for abuse of these drugs, which is a drug safety issue that requires careful consideration and putting sufficient safety measures in place for preventing misuse throughout clinical development.”

For Schedule I controlled substance psychedelics, the draft notes that activities associated with IND investigations “must comply with applicable Drug Enforcement Administration regulatory requirements.” Additionally, the agency notes that the “evidentiary standard for establishing effectiveness of psychedelic drugs is the same as for all other drugs. However, there are unique factors investigators may need to consider when designing their clinical trials if those trials are to be considered adequate and well-controlled.” The draft guidance also addresses considerations for safety monitoring and the importance of characterizing dose response and the durability of any treatment effect.