FIPA 2 Exam 3 Practice Exam 2026 - Free Practice Questions and Study Guide

In regulatory terms, NDA stands for New Drug Application. This is the formal submission to the U.S. FDA that a sponsor files to request permission to market a new medication in the United States. It bundles all the data from preclinical and clinical studies, plus details on how the drug is manufactured, labeled, and used (proposed indications). The FDA reviews the NDA to assess safety, efficacy, and quality of manufacturing. If approved, the drug can be marketed in the U.S. The other options aren’t the standard regulatory terms used for this submission.