Expanded access to psychedelic treatments: comparing American and Canadian policies
The United States Food and Drug Administration’s (FDA’s) August 2024 determination that an additional phase III study will be required to consider the approval of midomafetamine for the treatment of post-traumatic stress disorder (PTSD) could delay the potential approval of this promising treatment by several years.
Authors
- Jérémie Richard (ORCID: https://orcid.org/0000-0001-9893-1353)
- Jack E. Henningfield (ORCID: https://orcid.org/0000-0001-8387-0041)
- Albert Garcia‐Romeu (ORCID: https://orcid.org/0000-0003-2182-1644)
Institutions
- Johns Hopkins University (US)
- Abt Global (United States) (US)
Publication Details
- Journal
- General Psychiatry
- Published
- 2025-02-01
- DOI
- https://doi.org/10.1136/gpsych-2024-101894
- Citations
- 5
- Primary Topic
- Psychedelics and Drug Studies
- Type
- article
- Field-Weighted Citation Impact
- 11.53
Funders
- Canadian Institutes of Health Research