FDA Issues First Guidance on Clinical Trials for Psychedelic Drugs

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In the draft guidance, the FDA argues psychedelic drugs need to be evaluated for abuse potential during drug development. In its draft guidance, the FDA, while confirming that psychedelic drugs are subject to the same regulations and same evidentiary standards for approval as other drugs, acknowledges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 considerations when designing clinical trials. For example, psychedelic drugs can cause “intense perceptual disturbances and alterations in consciousness” that can last for several hours. By issuing this draft guidance, the FDA is providing drug developers and researchers guidance on how to design trials to meet regulatory hurdles for approval. The FDA’s action takes place as Congress begins to pay more attention to psychedelic drugs.

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Source JD Supra


Sara KlockMichael Werner

Holland & Knight LLP


The U.S. Food and Drug Administration (FDA or Agency) on June 23, 2023, released its first draft...

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