New Drug Application

A New Drug Application (NDA) is a formal process used by a pharmaceutical company to get approval from a regulatory agency, like the U.S. Food and Drug Administration (FDA), to sell a new medication. It includes detailed information about the drug’s safety, effectiveness, how it’s made, and potential side effects. The agency reviews this data to determine if the drug is safe and beneficial for public use. If approved, the drug can then be marketed and prescribed to patients. The NDA process ensures that new medications meet strict standards before reaching the market.