Investigational New Drug Application

**Definition:** An application that must be submitted to a regulatory agency (the FDA in the United States) before a drug can be studied in humans. This application includes results of previous experiments; how, where, and by whom the new studies will be conducted; the chemical structure of the compound; how it is thought to work in the body; any toxic effects found in animal studies; and how the compound is manufactured. (From the New Medicines in Development Series produced by the Pharmaceutical Manufacturers Association and published irregularly.)

**Tree numbers:** - E05.290.250.400 - E05.337.300.400

**Synonyms:** - Investigational New Drug Applications