What does the abbreviation NDA stand for?

The abbreviation NDA stands for New Drug Application. This is a critical submission that pharmaceutical companies must file with the U.S. Food and Drug Administration (FDA) to seek approval for a new drug to be marketed in the United States. The NDA contains comprehensive data regarding the drug's safety, efficacy, manufacturing processes, and labeling information. It is an essential step in the drug approval process and allows regulatory authorities to evaluate the potential benefits and risks of a new therapeutic agent.

This process ensures that any new drug meets the necessary standards for safety and effectiveness before it is made available to patients. Understanding the NDA is fundamental for professionals involved in regulatory affairs, as it plays a significant role in bringing new medications to the market.

The other options do not accurately reflect the official terminology used in regulatory submissions. New Development Application, Notable Drug Assessment, and Notifiable Drug Application are not recognized terms in the context of FDA regulatory processes for new drugs.