New Drug Application

Definition 1

A regulatory document submitted to the FDA proposing the approval of a new drug to be marketed and sold in the U.S. It includes supporting data from both animal and human studies that was initially provided in the Investigational New Drug application (IND). (NCI Thesaurus)

Definition 2

A type of application which a pharmaceutical manufacturer or its agent requests permission from the United States Food and Drug Administration (FDA) for a license to market a drug for one or more specified indications; besides a chemical and pharmacologic description of the drug, the application must show the results of clinical trials conducted with respect to the indication for which a license is requested. (Food and Drug Administration)

Definition 3

Stability data submitted to a new human drug application. (Food and Drug Administration)

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