Drug Approval
| Definition: |
Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug. |
| Notes: |
by govt regulatory agency, U.S. (not restricted to FDA) or foreign |
| Also Called: |
Food and Drug Administration Drug Approval Process,New Drug Approval Process,New Drug Approval,Drug Approval Process |
Drug Approval Categories.
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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.) |
Drug Approval Definitions and Terms
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