PDUFA date
The FDA target action date for an NDA or BLA, set under the Prescription Drug User Fee Act.
Definition
The PDUFA date is the date by which the FDA aims to issue a decision on a drug application. For standard review, it is 10 months after filing acceptance; for priority review, 6 months. The PDUFA date is a critical commercial catalyst — share prices routinely move several percent on PDUFA-date approval or refusal letters.
See also
- NDA — New Drug Application — the FDA submission required to market a new small-molecule drug in the US.
- BLA — Biologics License Application — the FDA submission required for biologics (proteins, antibodies, gene therapies).
- Priority review — FDA designation that shortens NDA/BLA review to 6 months for drugs offering significant improvement.