This talk will focus on the regulatory challenges involved in developing psychedelic-assisted psychotherapy through the FDA/EMA process. Issues to be discussed will be the initial reasons behind the strategy of working through the FDA/EMA process, the rationale for why MAPS is prioritizing MDMA as the psychedelic and PTSD as the clinical condition to move first into Phase 3 trials, standardizing the therapeutic method with treatment manual and adherence criteria, how we approached the double-blind issue, the importance of an outcome measure that is administered by Independent Raters and the procedure we’ll use to minimize bias, how we reached out to the Department of Defense and Department of Veterans Affairs National Center for PTSD, the issue of the FDA’s Risk Evaluation and Mitigation System (REMS) to regulate MDMA-assisted psychotherapy post-approval, and the FDA’s data exclusivity program and MAPS’ sustainability plan through our MAPS Public Benefit Corporation.