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FDA Releases Draft Guidance For Psychedelic Drugs Research

By Leo Bear-McGuinness

Published: Jun 29, 2023   
Magic mushroom in a test tube.

Image credit: iStock

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The US Food and Drug Administration (FDA) has released draft guidelines for scientists conducting clinical trials for psychedelic drugs.

This is the first such psychedelics guidance the FDA has released.

The draft includes protocol recommendations for clinical trials, from conducting microscopic evaluations of the hearts of rodent models given psychedelics, to carrying out human abuse potential studies alongside the trials. The full guidance document can be read here.

Comments from the public and relevant professionals are welcome and will be accepted until August 25.

“Psychedelic drugs show initial promise as potential treatments for mood, anxiety and substance use disorders,” Tiffany Farchione, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, said in a statement published on June 23.

“However, these are still investigational products. Sponsors evaluating the therapeutic potential of these drugs should consider their unique characteristics when designing clinical studies.”

“By publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug development programs and provide information on how to address these challenges. The goal is to help researchers design studies that will yield interpretable results that will be capable of supporting future drug applications.”


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