An investigational new drug (IND) application is an application that must be submitted to the FDA to obtain permission to begin a clinical trial. An IND application is submitted by the clinical trial sponsor and must include documentation of the pharmacology and toxicology studies demonstrating that the compound has proven safe in animal testing. It will also contain manufacturing information, clinical protocols for the proposed clinical trial, and information on the study investigators and staff. This report must be submitted to the FDA before human testing may begin. To learn more about an IND application and why it is important for drug development, click on the links below.
- FDA: Overview of Investigational New Drug Applications
What is an IND application and why is it important in drug development?
