On-Demand
Navigating the Regulatory Process for Psychedelic Medicine

The introduction of psychedelic medicines and therapies into the United States healthcare system is happening fast. Studies continue to show the efficacy of medicines like MDMA, Psilocybin, and Ketamine in treating serious mental health illnesses like PTSD and Major Depression. In anticipation of FDA approval and medicalization, many clinicians have jumped at the opportunity to be trained in these modalities and others are interested in learning more, but many questions remain unanswered around the current policy and regulatory landscape, changes needed to welcome these medicines into our current healthcare system, and other issues requiring coalition building and consensus among healthcare professionals and governing bodies. This goal of this presentation is to provide clinicians with an overview the history and current state of regulations and policy concerning drug development and the implications for clinicians interested in practicing psychedelic-assisted therapy.

The target audience for this presentation is clinicians who work or are planning to work with psychedelic-assisted therapy in research or community-based settings and others who are interested in the process by which psychedelic-assisted therapy can become approved.

• Articulate the role of colonization in the formation of drug policy in the United States
• Identify one way US Drug policy impacts psychedelic drug research
• Define and delineate FDA breakthrough designation from other FDA designations
• Identify the DEA scheduling status of psilocybin, MDMA, and ketamine
• Identify where MDMA, psilocybin, and ketamine are in the process of approval for use in psychedelic-assisted therapy
• Name at least one policy issue currently facing the field of psychedelic-assisted therapy
• Identify at least 1 way to support the successful adoption of psychedelic therapies post FDA-approval

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