FDA’s Draft Guidance for Psychedelic Studies
In June 2023, the FDA issued its first draft guidance on clinical trials with psychedelic drugs. The 14-page document presents non-binding guidance, or recommendations, regarding study design and other considerations for drug development programs investigating the therapeutic potential of…
Phase II and Phase III MDMA-Assisted Therapy clinical trials
In Phase II studies, researchers administer the drug to a group of patients with a disease or condition. A Phase III clinical trial tests the safety and how well a new treatment works compared with a standard treatment.