Lexology June 26, 2023
The U.S. Food and Drug Administration (FDA or Agency) on June 23, 2023, released its first draft guidance concerning design and desired features of clinical trials for psychedelic drugs LSD and MDMA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 post-traumatic stress disorder (PTSD). By issuing this draft guidance, the FDA is providing drug developers and researchers guidance on how to design trials to meet regulatory hurdles for approval.
In its draft guidance, the FDA, while confirming that psychedelic drugs are subject to the same regulations and same evidentiary standards for approval as other drugs, acknowledges that these drugs have “unusual characteristics” that merit special...
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