U.S. New Drug Application & FDA Approvals → New Drug Application

The New Drug Application (NDA) is the vehicle through which drug sponsors formally request that the FDA approve a new pharmaceutical for marketing in the U.S. following phase 3 of a clinical trial.

Regulation: NDAs are reviewed by FDA’s Center for Drug Evaluation and Research (CDER).

The goals of the NDA are to provide enough information to permit FDA reviewer to reach the following key decisions:

• Whether the drug is safe and effective in its proposed use, and whether the benefits of the drug outweigh the risks.
• Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain.
• Whether the methods used in manufacturing are adequate to preserve the drug’s identity, strength, quality, and purity.

The components of an NDA include what happened during the clinical tests, ingredients of the drug, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged.

• The FDA will review the studies and evidence provided on the drug product, as well as the drug labelling and inspect the facility where the drug is manufactured.

IND vs. NDA

• The Investigational New Drug Application (IND) talked about earlier in this module is a request to begin clinical investigation
• NDA is a formal request for marketing approval