For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. 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 data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.

 

The goals of the NDA are to provide enough information to permit FDA reviewer to reach the following key decisions:

 

•Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.

•Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain.

•Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity.