New Drug Application

Also called NDA.

According to the FDA, “The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.” The application should contain sufficient information for the FDA to make a marketing decision.  “The documentation required in an NDA is supposed to tell the drug’s whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged.”  Compare with Marketing Authorisation Applications in the European Union.

Also see Biologic License Application.