New Drug Application

NDA

Tanım

The formal request submitted to the FDA by a pharmaceutical company to gain approval to market a new drug in the United States. An NDA contains comprehensive data on the drug's chemistry, manufacturing, pharmacology, clinical trials, and proposed labeling. The review process typically takes 10-12 months.

Örnek

After completing Phase III trials showing efficacy and safety, the manufacturer files an NDA. If approved, the drug can be marketed and prescribed.

İlgili Terimler

Drug Recall Orphan Drug Clinical Trial Phases

Kılavuzlarda Geçiyor

How the FDA Approves New Drugs

A step-by-step guide to the FDA's new drug approval process, from laboratory discovery through clinical trials to the pharmacy shelf.
The Orphan Drug Act Explained

Why rare diseases were historically neglected by drug developers and how the 1983 Orphan Drug Act transformed treatment options for …
Why Drugs Cost So Much

A clear-eyed look at the forces that drive prescription drug prices — from billion-dollar R&D pipelines to marketing costs, patent …
AI in Drug Discovery

Artificial intelligence is reshaping how new medicines are found and developed. Learn how AI tools accelerate target identification, molecule design, …