A New Drug Application (NDA) is the formal application submitted to the U.S. Food and Drug Administration (FDA) to obtain approval to market a new medicinal product in the United States. The NDA is the equivalent of the Marketing Authorisation Application (MAA) in Europe and represents the culmination of a lengthy drug development process.
The NDA is an extremely comprehensive dossier containing all information about the medicinal product that the FDA needs to assess its safety and efficacy. It includes data on active substance chemistry and manufacturing (CMC), the results of all preclinical animal studies, and the complete data from all clinical trials in humans. FDA reviewers evaluate these data in depth to ensure that the demonstrated therapeutic benefit outweighs the potential risks. CROs play a critical role in preparing the clinical sections of this dossier to ensure a successful submission.