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Definition of FDA priority review designation and its effect on PDUFA review timelines.
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Priority review is an FDA designation that sets a target review goal of six months from filing acceptance for drugs that would provide significant improvements in safety or effectiveness compared to available therapies. Standard review typically targets ten months under PDUFA.
Priority review compresses regulatory timelines and signals FDA assessment of unmet need. Companies disclose priority review grants in press releases and SEC filings, often alongside assigned PDUFA dates.
A novel therapy for a serious condition with no adequate alternatives may receive priority review upon NDA acceptance, shortening the time to a regulatory action date disclosed to investors.