Abstract
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 language | English (US) |
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Title of host publication | Epilepsy, Second Edition |
Publisher | wiley |
Pages | 287-300 |
Number of pages | 14 |
ISBN (Electronic) | 2020027893, 9781119431893 |
ISBN (Print) | 2020027892, 9781119431824 |
DOIs | |
State | Published - Jan 1 2021 |
ASJC Scopus subject areas
- General Medicine