What is submitted for final approval if Phase III trials prove a drug is safe and effective?

The correct answer is that a New Drug Application (NDA) is submitted for final approval following successful Phase III trials that demonstrate a drug's safety and efficacy.

After a drug has undergone extensive testing through preclinical studies and three phases of clinical trials, Phase III trials serve to confirm the drug’s effectiveness and monitor any adverse reactions in larger groups of patients. If the results from these trials are favorable, the manufacturer compiles all the data and submits a NDA to the Food and Drug Administration (FDA) for review. This application includes comprehensive information about the drug, including the results of the clinical trials, proposed labeling, and information on manufacturing processes.

The NDA process is critical because it allows the FDA to thoroughly evaluate the new drug's risk-benefit profile before it can be marketed and prescribed to patients. An approved NDA indicates that the drug has met all necessary requirements for safety and efficacy established by the FDA.

In contrast, a New Compound Request (NCR) and an Investigational New Drug (IND) application are earlier steps in the process before reaching the NDA stage. The Abbreviated New Drug Application (ANDA) pertains specifically to generics and is submitted after the original branded drug has been approved, ensuring it is bioequivalent to the