Investigational Therapy and Drug Approval Process within the US and Cannabidiol

This chapter explains the complex pathway to approval of novel epileptic therapies in a straightforward manner focusing solely on the treatment of seizures through medications and other investigational therapy options. Adhering to their mission, the US Food and Drug Administration (FDA) warrants a thorough scientific review process of any new pharmaceutical or other therapy involving medical devices and/or biologics that would be used to treat epilepsy; ensuring that the products available to the consumer are safe and effective. Conventionally, there are five stages in the process of developing a pharmaceutical therapy and receiving FDA approval for marketing and open-use in human patients. They are discovery and development, pre-clinical research, clinical research, FDA review, FDA action, and post-approval risk assessment. The chapter also addresses cannabidiol for epilepsy; a recently approved seizure treatment.