CVS Pharmacy Technician Certification Practice Test 2025 - Free Practice Questions and Study Guide

In pharmaceutical terms, "NDA" stands for New Drug Application. This is a formal proposal submitted to the regulatory authority, such as the Food and Drug Administration (FDA) in the United States, to request approval for a new pharmaceutical drug to be sold and marketed. The NDA includes comprehensive data about the drug's safety and efficacy, labeling, and manufacturing processes, along with clinical trial results. It is a critical step in bringing new medications to market, ensuring that they meet necessary standards for public health and safety before they become available to consumers.

The importance of the NDA lies in its role in evaluating and confirming that a new drug is both safe for human use and effective for its intended purposes. Approving an NDA is a significant regulatory milestone, as it signifies that the drug has successfully passed through various phases of preclinical and clinical testing.