New Drug Application (NDA)
The FDA application submitted by a pharmaceutical company requesting approval to market a new drug in the United States.
An NDA is the formal vehicle through which a drug sponsor demonstrates to the FDA that a new drug is safe and effective for its proposed indication. The NDA must contain the complete data package from the drug's development program: all clinical trial data, preclinical animal studies, CMC data, proposed labeling, and the sponsor's proposed risk management strategy.
NDAs are organized according to the Common Technical Document (CTD) format — a globally harmonized structure with five modules covering administrative information, summaries, quality (CMC), nonclinical studies, and clinical data. A typical NDA submission comprises hundreds of thousands of pages. The FDA's PDUFA review clock starts at submission and typically allows 10 months for standard review and 6 months for priority review. Document intelligence applied to NDA submissions allows regulatory teams to quickly locate specific data points — a particular clinical study report, a stability data table, a labeling discussion — across a massive document set.
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