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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 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Review Peer reviewed
Keywords Drug approval Alternative medicine Clinical research Pharmacology Pathology
Citations 11
Key findings The FDA's draft guidance on psychedelics research includes recommendations that may be contentious.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 The FDA’s draft guidance on psychedelics research includes several recommendations that may be contentious.