new drug application

The New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. The goals of the NDA are to provide enough information to permit FDA reviewers to establish the following:Is the drug safe and effective in its proposed use(s), and do the benefits of the drug outweigh the risks?Is the drug’s proposed labeling (package insert) appropriate, and what should contain?Are the methods used in manufacturing (Good Manufacturing Practice, GMP) the drug and the controls used to maintain the drug’s quality adequate to preserve the drug’s identity, strength, quality, and purity?
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an application made by a drug manufacturer to FDA requesting marketing approval of a new drug.

An application submitted by a drug manufacturer to the Food and Drug Administration (FDA) for a license to market and sell a particular drug in the United States. The drug manufactor files an NDA after information from clinical trials is available for FDA review.
See Also: Investigational New Drug Application
  

An application submitted by the manufacturer of a drug to the FDA -- after clinical trials have been completed -- for a license to market the drug for a specified indication.