The development of novel pharmaceuticals whose pharmacology is dependent on cannabinoid receptors is an increasingly active area of research and development. However, the confusing and conflicting legal status of cannabis and its active constituents can inhibit development, as companies encounter significant and unique barriers to approval and appropriate scheduling. Experiences with development and regulatory submission of other CNS-active drugs, including the development of the required abuse potential assessment, provide important precedents and models for cannabinoids.
In this webinar, presenters will focus on the role of an abuse potential assessment (also referred to as the Controlled Substances Act 8-factor analysis) in the development of cannabinoid products and how it relates to the U.S. scheduling process, and related interactions with the Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA).
From Pinney Associates, presenters include:
- Jack Henningfield, Ph.D. - Vice President of Research, Health Policy, and Abuse Liability
- Reginald Fant, Ph.D. - Director of Clinical Pharmacology and Abuse Potential Assessment