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.)

Year introduced: 1993

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Tree Number(s): E05.290.250.400, E05.337.300.400

MeSH Unique ID: D017387

Entry Terms:

• Investigational New Drug Applications

Previous Indexing:

• Drugs, Investigational (1990-1992)

All MeSH Categories
Analytical, Diagnostic and Therapeutic Techniques and Equipment Category
Investigative Techniques
Drug Development
Drug Approval
Investigational New Drug Application

All MeSH Categories
Analytical, Diagnostic and Therapeutic Techniques and Equipment Category
Investigative Techniques
Evaluation Studies as Topic
Drug Approval
Investigational New Drug Application