FDA Issues Guidance for Clinical Research & Product Development
SILVER SPRING, M.D. – The Federal Drug Administration’s (FDA) Center for Drug Evaluation and Research issued its final nonbinding recommendations for clinical cannabis research this week. The eleven-page guidance document is intended to outline the department’s thinking on several issues regarding the development of human drugs containing cannabis or cannabis-derived compounds, sources of research materials, and considerations of control status under the Controlled Substances Act. The document, “ Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research ,” specifically deals with cannabis-related products intended to diagnose, cure, mitigate, prevent, or treat a disease, or any non-food products intended to affect the structure or any function of the human body. The FDA considers a cannabis product a drug when it’s “marketed with a claim of therapeutic benefit, or with any other disease-related claim,” as defined in section 201(g) of the Federal Food, Drug...