FDA Finalizes Guidance On 'Unique Challenges' Of Psychedelic Research And Schedules Hearing On Therapeutic Uses

FDA Finalizes Guidance On 'Unique Challenges' Of Psychedelic Research And Schedules Hearing On Therapeutic Uses

The Food and Drug Administration (FDA) has issued finalized guidance to help researchers studying the therapeutic benefits of psychedelics navigate the “unique challenges” of such investigations. The agency also announced it will be holding a public hearing on psychedelic therapy issues in September. “In recent years, interest in the therapeutic potential of psychedelic drugs has been increasing,” the FDA document published on Monday says. “Drug…

FDA Finalizes Guidance On ‘Unique Challenges’ Of Psychedelic Research And Schedules Hearing On Therapeutic Uses

The Food and Drug Administration (FDA) has issued finalized guidance to help researchers studying the therapeutic benefits of psychedelics navigate the "unique challenges" of such investigations. The agency also announced it will be holding a public hearing on psychedelic therapy issues in September. "In recent years, interest in the therapeutic potential of psychedelic drugs has been increasing," the FDA document published on Monday says. "Drug…

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In June 2023, FDA issued the first draft guidance on clinical investigations involving psychedelics.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… Source