The regulation and control of new drugs in the United States is based on the new drug application (NDA). The NDA is a regulatory document submitted by the sponsor to FDA as a formal request for marketing approval. The NDA outlines how the drug performed during clinical tests, all ingredients, the results of animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged.
The goal of the NDA is to provide enough information to enable an FDA reviewer to determine whether:
- the drug is safe and effective for its proposed use, and if the benefits of the drug outweigh the risks.
- the proposed package insert is appropriate, and what it should contain.
- the methods used in manufacturing the drug, and the controls used to maintain the drug's quality are adequate to ensure the drug's identity, strength, quality, and purity.