The US Food and Drug Administration (FDA) has created its first draft guidance for clinical studies into psychedelics, issued in response to bipartisan legislation seeking clinical trial guidelines. The guidance covers classical psychedelics including LSD and psilocybin, as well as empathogens such as MDMA, but does not cover substances such as ketamine. The FDA stressed the importance of characterising the dose-response and durability of any treatments, as well as potential drug interactions for patients on antidepressants or mood stabilisers. Tiffany Farchione, director of the Division of Psychiatry at CDER, argued that while psychedelics held “initial promise”, they must still be considered “investigational products”.
