FDA Issues Final Psychedelics Guidance, Schedules September Hearing on the Future of Psychedelic Therapies

In June 2023, FDA issued the first draft guidance on clinical investigations involving psychedelics. The 11-page document offered pointers on everything from nonclinical research and chemistry, manufacturing, and controls through to clinical studies and abuse potential assessments.

Since then, a round of stakeholder feedback had sat unaddressed for the better part of three years, with many wondering when final guidance would be published. Following the April psychedelics-focused executive order, on April 24th FDA shared that it would release its final guidance “imminently”. This morning, eighty days later, it has done so (PDF).

While key elements of the draft guidance are broadly intact, certain edits and additions represent meaningful changes to the agency’s views on matters like selecting trial populations, assessing safety both pre- and post-approval, and designing long-term follow-up.

Here, we explore the changes that appear in the final document, compare them with stakeholder feedback received in the Summer of 2023, and discuss a broader psychedelics-focused public hearing announcement and request for comment issued by FDA and the Department of Health and Human Services (HHS) today.

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Track Changes: Our Line by Line Review of Edits, Additions, and Clarifications

To begin with, we run through the final guidance section-by-section and highlight changes from the draft...