FDA issues first draft guidance on psychedelic research

The U.S. Food and Drug Administration released draft guidance for conducting clinical trials with psychedelic drugs like psilocybin and MDMA, acknowledging that designing such studies presents unique challenges. The guidance addresses considerations for the industry to evaluate safety and effectiveness of these substances.

Study at a glance

Abstract

Observing that designing clinical studies to evaluate the safety and effectiveness of psychedelic substances presents a number of unique challenges that require careful consideration to the industry, the U.S. Food and Drug Administration (FDA) last month issued, for the first time, draft guidance for conducting clinical trials with psychedelic drugs such as psilocybin and MDMA (ecstasy).