New Drug Application
NDADefinition
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.
Example
After completing Phase III trials showing efficacy and safety, the manufacturer files an NDA. If approved, the drug can be marketed and prescribed.
Related Terms
Mentioned in Guides
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How the FDA Approves New DrugsA step-by-step guide to the FDA's new drug approval process, from laboratory discovery through clinical trials to the pharmacy shelf.
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The Orphan Drug Act ExplainedWhy rare diseases were historically neglected by drug developers and how the 1983 Orphan Drug Act transformed treatment options for …
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Why Drugs Cost So MuchA clear-eyed look at the forces that drive prescription drug prices — from billion-dollar R&D pipelines to marketing costs, patent …
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AI in Drug DiscoveryArtificial intelligence is reshaping how new medicines are found and developed. Learn how AI tools accelerate target identification, molecule design, …