FDA Issues First Guidance on Clinical Trials for Psychedelic Drugs

The U.S. Food and Drug Administration (FDA or Agency) on June 23, 2023, released its first draft guidance concerning design and desired features of clinical trials for psychedelic drugs LSD and MDMA There has been growing interest in studying the use of psychedelic drugs for patients with conditions such as treatment-resistant depression, substance-use disorders and……
By: Holland & Knight LLP