New Drug Application (NDA)

The new drug application is the process through which drug manufacturers formally request approval from the FDA for the sale and marketing of a new pharmaceutical product for a specified indication.

The documentation for the NDA provides the FDA with a comprehensive understanding of the drug. The application is submitted after the clinical trials are completed and all the data from the pretrial animal and laboratory studies, and human clinical trials are incorporated into the NDA.

In order to grant the license to market the drug, the FDA must receive enough information to assess:

  • Safety and efficacy of the drug for the indication, and whether the benefits outweigh the risk.
  • Sufficiency of the information provided in the package insert.
  • Adequacy of manufacturing methods and controls used to preserve the drug’s identity, strength, quality, and purity.

Source: New Drug Application (NDA). (2019, June 10). U.S. Food and Drug Administration. Retrieved January 8, 2022, from