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 it 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?