A New Drug Application (NDA) is a document submitted to the Food and Drug Administration (FDA) to request authorisation to market a medical product in the United States. The information in the NDA must allow the FDA to make the following judgements (quoted from FDA website):
– ‘Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks
– Whether the drug’s proposed labelling (package insert) is appropriate, and what it should contain.
– 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 NDA must include information about the medicine’s ingredients, outcomes of the animal and clinical studies, how it behaves in the body, and how it is manufactured and packaged.