What Does NDA Stand For?

NDA stands for New Drug Application

NDA, or New Drug Application, is a formal request submitted to the U.S. Food and Drug Administration (FDA) for approval to market a new pharmaceutical drug. The application includes comprehensive data on the drug's safety, efficacy, manufacturing processes, and labeling information, compiled from preclinical and clinical trials. The NDA process is critical for ensuring that new medications meet regulatory standards before they can be made available to the public.

Other Meanings for NDA