What Does INDA Stand For?

INDA stands for Investigational New Drug Application

The Investigational New Drug Application (INDA) is a comprehensive submission to regulatory authorities that allows a pharmaceutical company to begin clinical trials of a new drug in humans. This application provides detailed information regarding the drug's composition, manufacturing processes, preclinical data, and proposed clinical study protocols. The INDA is a critical step in the drug development process, ensuring the safety and efficacy of potential new therapies before they are tested in the general population.