new drug application


New Drug Application (NDA),

a document whereby 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.

New Drug Application

EBM
An application to FDA for a licence to market a new drug in the USA.

new drug application

See NDA.

new drug application

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NDA

An application requiring approval by the Food and Drug Administration before any new drug is marketed to the general public. Before approval, the manufacturer must provide the FDA with scientifically acceptable evidence of the new drug's safety and efficacy.