About The Medical Condition Investigational New Drug Application

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Find the definition of the medical term Investigational New Drug Application. Investigational New Drug Application defined and explained for easy understanding at the Medical Conditions from ClusterMed.info.

Investigational New Drug Application

Investigational New Drug Application Medical Condition Defined & Explained
Investigational New Drug Application Medical Condition

What's The Definition Of The Medical Condition Investigational New Drug Application?

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.)

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