Applications for FDA Approval to Market a New Drug

Companies seeking to market a new drug in the United States must submit a New Drug Application (NDA) demonstrating that the drug is safe and effective for its intended use. The NDA must include full reports of preclinical and clinical studies, the drug's composition, methods of manufacture, proposed labeling, and patent information.

The FDA reviews NDAs and may approve, request additional data, or issue a complete response letter. Abbreviated NDAs (ANDAs) are available for generic drugs that demonstrate bioequivalence to an approved reference product.