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New Drug Application

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.

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