Priority review
FDA designation that shortens NDA/BLA review to 6 months for drugs offering significant improvement.
Definition
Priority review is granted by the FDA for drugs that, if approved, would offer a significant improvement over available therapy. It shortens the standard PDUFA target action date from 10 months to 6 months from filing acceptance.
See also
- PDUFA date — The FDA target action date for an NDA or BLA, set under the Prescription Drug User Fee Act.
- Breakthrough Therapy — FDA designation that fast-tracks review of drugs with substantial improvement on clinically significant endpoints.
- Accelerated approval — FDA pathway allowing approval based on a surrogate endpoint, requiring confirmatory post-approval trials.