A New Drug Application (NDA) is a formal proposal submitted to the Food and Drug Administration (FDA) seeking approval for a new pharmaceutical product to be marketed in the United States. The NDA includes comprehensive data from preclinical and clinical trials, detailing the drug’s safety, efficacy, and proposed labeling. This application is a critical step in the FDA approval process, as it allows regulatory authorities to evaluate whether a new drug is safe and effective for public use.
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