NDA (New Drug Application)

A New Drug Application (NDA) is a formal request submitted to regulatory authorities, like the U.S. Food and Drug Administration (FDA), by a pharmaceutical company seeking approval to market a new drug. The NDA includes comprehensive data on the drug's safety, effectiveness, manufacturing processes, and labeling. This application undergoes rigorous review to ensure the drug meets necessary standards before it can be sold to the public. Ultimately, the NDA process is crucial for protecting public health by ensuring that new medications are both safe for use and effective for treating diseases.