FDA Psychedelic Drugs Guidance
Considerations for Clinical Investigations (Guidance for Industry)
FDA guidance (July 2026) for sponsors developing psychedelics—5-HT2A agonists including psilocybin and LSD, plus MDMA—as approved medicines. It addresses the regulatory pathway for Schedule I drugs in clinical trials and identifies methodological challenges: perceptual effects complicate blinding ('functional unblinding'), and the independent contribution of psychotherapy paired with dosing remains uncharacterized.
July 2026 (finalizing a June 2023 draft)
Source
LSDPsilocybin
FDA Division of Psychiatry, Center for Drug Evaluation and Research