Psychedelic drug development has moved from the margins to a live regulatory question, and this hearing is where the FDA formally takes the public's input. The hybrid session — , 12:30 to 4:30 p.m. ET — gathers perspectives on the potential future therapeutic use of psychedelic drug products, held in collaboration with federal partners.
Date, venue and registration
- Hearing: 14 September 2026, 12:30–4:30 p.m. ET
- Venue: White Oak Great Room, 10903 New Hampshire Ave., Silver Spring, MD
- Virtual: attendance option available; link via the FDA registration page
- Registration deadline: 11:59 p.m. ET, 21 August 2026 (covers attendance and presentation requests)
- Docket: FDA-2026-N-7542
- Organizer: US Food and Drug Administration
Why this hearing matters
How the FDA frames supervised use, session monitoring and post-treatment follow-up will shape every psychedelic development program that follows. Hearings like this one are where that framing starts: the testimony and docket comments become part of the record the agency draws on as it works out what approval in this category should require.
Who should attend
Regulatory affairs and clinical development professionals with psychedelic or CNS programs, medical and scientific affairs teams watching the category, and policy staff tracking how the agency approaches novel treatment paradigms. Presenting requires registering by the 21 August deadline; following the record needs only the virtual registration.
The FDA holds its PFDD meeting on nonhealing chronic wounds three weeks earlier, and the full events directory lists every FDA meeting we have verified.
Frequently asked questions
When is the FDA's public hearing on psychedelic drugs?
14 September 2026, from 12:30 p.m. to 4:30 p.m. Eastern Time, as announced in the FDA's Federal Register notice of 14 July 2026 (Docket No. FDA-2026-N-7542).
Can I attend the psychedelics hearing virtually?
Yes. The hearing is hybrid, with in-person attendance in the White Oak Great Room and a virtual option. Registration — including any request to present — must be completed by 11:59 p.m. ET on 21 August 2026.
What is the hearing about?
The FDA, working with federal partners, is taking feedback on issues associated with the potential future therapeutic use of drug products containing a psychedelic drug substance, including their use in supervised settings. It is a listening session that builds a public record, not an approval decision.
Sources & further reading
- Federal Register. Considerations for Potential Future Therapeutic Use of Psychedelic Drugs; Public Hearing; Request for Comments — 14 July 2026. federalregister.gov
Event details are published by the organizer and can change. Confirm the date, format and registration with the FDA before making plans. Last verified 16 July 2026.
