How Should the FDA Evaluate Psychedelic Medicine?
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| Key findings | The FDA's draft guidance on psychedelics research includes recommendations that may be contentious.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 The FDA’s draft guidance on psychedelics research includes several recommendations that may be contentious.
Citations in the library
Cited by 11
- Essentials of Informed Consent to Psychedelic Medicine JAMA Psychiatry April 10, 2024
- Psychedelics for the Treatment of Psychiatric Disorders: Interpreting and Translating Available Evidence and Guidance for Future Research. American Journal of Psychiatry 2025
- Psychedelic Medicine Exceptionalism. The American Journal of Bioethics 2025
- Psychedelic Therapy Scrutinized by FDA Advisory Committee? JAMA July 30, 2024
- Psychedelics, entactogens and psychoplastogens for depression and related disorders British Journal of Pharmacology June 15, 2025
and 6 more in the library