FDA Publishes First Draft Guidance On Psychedelic Drug Trials

By Lia DeGroot / June 23, 2023 at 5:52 PM
FDA on Friday (June 23) published its first draft guidance on clinical trials for psychedelic drugs, coming as research into use of psychedelics to treat conditions like depression and post-traumatic stress disorder becomes increasingly widespread. FDA says development of psychedelic drugs poses several challenges, including minimizing the risk of the drugs being misused and addressing role that psychotherapy plays in psychedelic drug administration. “By publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug...


Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.