FDA finalizes psychedelic clinical trial guidance and schedules September public hearing

U.S. FDA (regulatory) — The FDA released final guidance on considerations for psychedelic clinical investigations, finalizing its 2023 draft and offering sponsors more flexibility on modeling abuse potential and measuring efficacy while addressing functional-unblinding challenges.

The agency also scheduled a September 14, 2026 public hearing on the therapeutic use of psychedelics in supervised settings. Analysts characterized the receptive tone as reducing regulatory risk for developers such as Compass Pathways, AtaiBeckley, Cybin/Helus and GH Research.

Source: techtimes.com

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