New Drug Application (NDA)

What is a New Drug Application (NDA)?

A new drug application (NDA) is how drug sponsors formally propose a new pharmaceutical for U.S. Food and Drug Administration (FDA) approval. The data gathered during the animal studies and human clinical trials of an investigational new drug (IND) are submitted as part of the NDA.

The documents submitted as part of the NDA tell the drug’s complete story, including its chemical composition, how it’s manufactured, how the drug behaves in the body, its performance during the clinical trials, its proposed use indications, and how it will be packaged and labeled.

If the FDA determines that the submitted data support the approval of the drug, it grants marketing authorization, allowing the pharmaceutical company to commercialize the drug in the U.S. If the FDA finds deficiencies or requires additional information, it may issue a Complete Response Letter (CRL), prompting the company to address the concerns before the application can be approved.

The NDA differs from a Biologics License Application (BLA), which is required for those looking to market and sell biological products. In comparison, the NDA is only for the marketing and sales of drugs.

How does an NDA improve healthcare?

An NDA’s goal is to provide enough information to the FDA for it to determine whether the drug is safe and effective for its proposed uses and whether its benefits outweigh the possible risks. The NDA also helps the FDA reviewer analyze if the drug’s proposed labeling is appropriate, and whether the methods used to manufacture the drug are adequate for preserving the drug’s identity, quality, and strength. By supplying all this information to the FDA, it can then verify that the drug is safe and effective, leading to better healthcare for patients within the targeted population.