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How Should the FDA Evaluate Psychedelic Medicine?

Mason Marks, I. Glenn Cohen

New England Journal of Medicine November 4, 2023 DOI: 10.1056/nejmp2308940 via OpenAlex

Summary

AI-generated from the abstract

The FDA's draft guidance on psychedelics research includes recommendations that may be contentious, even as mounting clinical evidence could lead to approval of new psychedelic medicines.

Study at a glance

Characteristics Review Peer reviewed
Keywords Drug approval Alternative medicine Clinical research Pharmacology Pathology
Citations 11
Key finding The FDA's draft guidance on psychedelics research includes recommendations that may be contentious.

Abstract

Mounting clinical evidence could lead to the approval of new psychedelic medicines. The FDA’s draft guidance on psychedelics research includes several recommendations that may be contentious.

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