A Psychedelic Shift: Assessing the Potential for Nonmedical Use in a Changing Regulatory Landscape

The US Food & Drug Administration (FDA) requires that the potential for nonmedical use must be assessed for any investigational new drug that has CNS activity. Current regulatory recommendations may lack the nuance required to appropriately evaluate drugs with novel or previously unrecognized drivers of nonmedical use. Capturing and assessing the experiences, subjective effects, and/or changes in consciousness that may drive additional use for psychedelic drugs poses a challenge for the industry as a whole.

This MMS Experts Insights Webinar will outline the requirements for an abuse potential summary in a marketing application and address the unique challenges associated with assessing the nonmedical use (e.g., abuse or misuse) potential of psychedelic drugs.

Watch This Webinar To:

• Gain a deeper understanding on FDA guidance for the nonmedical use of psychedelics in drug development
• Determine key topics for conducting targeted nonmedical use related literature searches
• Identify challenges associated with controlled scheduling in psychedelics
• Understand the type of nonmedical use-related adverse events that need to be collected during CNS-active drug development

What You Will Learn:

• Lexicon updates and the evolution of nonmedical use terminology in drug development
• Best practices for assessing nonmedical use during drug development
• Tips for engaging with global health authorities regarding nonmedical use of psychedelics
• Unique challenges associated with assessing nonmedical use in psychedelics research

Who Will Benefit From Attending?

• Regulatory Affairs and Submissions Professionals
• Clinical Operations and Clinical Development Resources
• Pharmaceutical and Academic Researchers
• Veteran Affairs Healthcare Providers

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