New Drug Applications (NDA)

A New Drug Application (NDA) is a detailed submission to regulatory authorities like the FDA to get approval for a new medicine. It includes data from laboratory and clinical tests showing the drug’s safety, effectiveness, manufacturing process, and potential risks. The goal is to demonstrate that the drug benefits outweigh its risks and to ensure it can be produced consistently at high quality. Once approved, the drug can be marketed and prescribed to patients. The NDA process helps protect public health by thoroughly evaluating new medications before they reach the market.