New Drug Application

Source:http://linkedlifedata.com/resource/umls/id/C2347344

NCI: Stability data submitted to a new human drug application. (Stability),NCI: 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. (eCTD)

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