The release of the FDA’s draft guidance on psychedelic research marks a significant milestone in mental health treatment. The 14-page document provides researchers with a comprehensive framework to conduct studies on psychedelic drugs, which have shown initial promise in treating mood, anxiety, and substance use disorders. Covering various aspects of drug development, the guidance offers insights into trial conduct, data collection, subject safety, and new drug application requirements. By outlining the unique challenges inherent in designing psychedelic drug development programs, the FDA aims to assist researchers in designing studies that yield reliable and interpretable results, supporting future drug applications.