Published on
June 28, 2023

FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs

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The U.S. Food and Drug Administration (FDA) has published a draft guidance outlining considerations for researchers investigating the use of psychedelic drugs for potential medical treatments.

The guidance is the FDA's first of its kind and provides insights to industry on designing clinical trials for psychedelic drugs.

Psychedelic drugs have shown promise in treating conditions such as depression, post-traumatic stress disorder, and substance use disorders, but designing clinical studies for these compounds presents unique challenges.

The draft guidance aims to help researchers address these challenges by providing advice on study design, data collection, subject safety, and new drug application requirements.

The FDA encourages public comments on the draft guidance within 60 days to ensure a comprehensive review.