NDA
New Drug Application — the FDA submission required to market a new small-molecule drug in the US.
Definition
A New Drug Application (NDA) is the formal request a sponsor submits to the US Food and Drug Administration to seek approval to market a new small-molecule pharmaceutical product in the United States. The NDA must contain all preclinical and clinical study results, proposed labelling, manufacturing details, and chemistry data. Biologics use a Biologics License Application (BLA) instead.
See also
- BLA — Biologics License Application — the FDA submission required for biologics (proteins, antibodies, gene therapies).
- PDUFA date — The FDA target action date for an NDA or BLA, set under the Prescription Drug User Fee Act.