What does NDA stand for?

The term NDA stands for New Drug Application. This is a critical step in the drug approval process in the United States, overseen by the Food and Drug Administration (FDA). When a pharmaceutical company has conducted sufficient research and clinical testing to demonstrate that a new drug is safe and effective, it submits an NDA to the FDA for review.

The NDA package includes extensive data, such as clinical trial results, proposed labeling, and manufacturing information. The review process helps ensure that any new drug meets the necessary standards before it can be marketed and sold to the public. Thus, the New Drug Application is essential for regulatory approval and enables the oversight of drug safety and efficacy in the healthcare market.

In contrast, terms like New Device Approval, Novel Drug Assessment, and New Development Agreement do not accurately reflect the formal process for new pharmaceutical products concerning regulatory submissions in the U.S. They either refer to different aspects of product approval or do not exist within the framework of FDA terminology related to drug approval processes.