Although more than half of U.S. states have legalized the use of medical marijuana, the U.S. Food and Drug Administration (FDA) has not yet recognized or approved the cannabis plant for therapeutic use. This presentation will provide an overview of FDA’s framework for regulating drugs and explain the process of FDA review and approval of new drugs. Special attention will be given to discussing the unique regulatory challenges and opportunities associated with developing cannabis therapies in the U.S., e.g., navigating the requirements of multiple federal regulatory agencies (FDA, NIDA, and DEA), developing botanical drug products, and FDA programs that grant expanded access to, and expedited review of, drugs intended to treat serious or rare diseases.
• Understand the requirements and process for obtaining FDA approval of new drugs, including phases of research and development, protocol development, approval of investigational new drug (IND) applications and new drug applications (NDAs).
• Understand unique regulatory challenges associated with developing cannabis therapeutics in the U.S.