NDA stands for?

• A. National Drug Assessment
• B. Non-Drug Application
• C. Novel Drug Analysis
• D. New Drug Application

Answer: (D)

The main idea here is the regulatory submission used to obtain U.S. marketing approval for a new drug. NDA is the acronym for New Drug Application, which is the formal package the sponsor submits to the FDA. It brings together all the evidence that the drug is safe and effective for its intended use, along with comprehensive information on how the drug is manufactured and controlled (chemistry, manufacturing, and controls), proposed labeling, and plans for safety monitoring. This combination of clinical data, safety evaluation, and manufacturing details is what the FDA reviews to decide whether the drug can be marketed.

That’s why this answer fits best: the term New Drug Application is the standard, recognized FDA submission for approving a new pharmaceutical product. The other phrases don’t reflect the official regulatory submission used for new drugs in the U.S. context. For added context, keep in mind that generics use an abbreviated form of the same concept (ANDA), and biologics use a Biologics License Application (BLA).