FDA Finalizes Psychedelic Drug Clinical Guidance and Schedules September Public Hearing

The FDA scheduled a public hearing for September 14, 2026, titled “Considerations for Potential Future Therapeutic Use of Psychedelic Drugs” (Docket FDA-2026-N-7542). The hearing seeks input on the potential future therapeutic use of psychedelic drug products in supervised and supportive settings. Requests to present are due August 21, and written comments close October 5. The FDA explicitly excludes comments on legalization, decriminalization, state and local program merits, scheduling, and religious or ceremonial use, while welcoming data from state programs. Separately, the HRSA RFI from the same Federal Register notice closes August 13.