About this document
FDA Guidance on Drug Abuse Potential Assessment by exequielreyes088 is a document available to read on EtoBox.
The document provides guidance from the FDA on assessing the abuse potential of new drugs, particularly those with central nervous system (CNS) activity. It outlines the necessary studies and data required for new drug applications (NDAs) to evaluate whether a drug has abuse potential and how it should be scheduled under the Controlled Substances Act. The guidance emphasizes that while it offers recommendations, it does not impose legally enforceable responsibilities on drug sponsors.
- Author
- exequielreyes088
- Language
- EN