A New Drug Application, also called a NDA, is submitted to the FDA for a new drug. Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.
An FDA reviewer studies the NDA and attempts to reach the following key decisions:
1. Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.
2. Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain.
3. 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.
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.
|Regulation of therapeutic goods in the United States|
The Food and Drug Administration's 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 (efficacy) in its proposed use(s) when used as directed, 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 the drug (good manufacturing practice [GMP]) and the controls used to maintain the drug’s quality adequate to preserve the drug’s identity, strength, quality, and purity?
Exceptions to this process include voter driven initiatives for "medical" marijuana in certain states.