Investigational Therapy and Drug Approval Process within the US and Cannabidiol

Gregory Sprout, Joseph I. Sirven, Gregory D. Cascino

Research output: Chapter in Book/Report/Conference proceedingChapter


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.

Original languageEnglish (US)
Title of host publicationEpilepsy, Second Edition
Number of pages14
ISBN (Electronic)2020027893, 9781119431893
ISBN (Print)2020027892, 9781119431824
StatePublished - Jan 1 2021

ASJC Scopus subject areas

  • Medicine(all)


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