Canadian Medical Guide > Analytical, Diagnostic and Therapeutic Techniques and Equipment > Investigative Techniques > Evaluation Studies > Drug Approval Terms and Definitions

Drug Approval

Medical 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.
Guide 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.

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 Medical Definitions and Terms

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Canadian Medical Guide > Analytical, Diagnostic and Therapeutic Techniques and Equipment > Investigative Techniques > Evaluation Studies > Drug Approval Terms and Definitions

Drug Approval

Drug Approval Medical Definitions and Terms

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