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Priority Review vs Standard Review

When the FDA accepts a drug application it assigns a review track. Standard review targets a decision in ~10 months; priority review targets ~6 months, for drugs that, if approved, would be a significant improvement in safety or effectiveness.

Standard review~10 months
Priority review~6 months

What it signals — and doesn't

Priority review reflects the potential importance of the drug, not a higher approval probability. Plenty of priority-review drugs get CRLs. It mainly compresses the timeline — useful for catalyst timing. Related: what is a PDUFA date.

See the live FDA PDUFA calendar →

FAQ

How long is FDA priority review?
About 6 months from filing, versus about 10 months for standard review.
Does priority review mean a drug is more likely to be approved?
No — it reflects the drug's potential importance and shortens the timeline; it is not a higher approval probability.

Related

What is a PDUFA date?
What is a Complete Response Letter (CRL)?
FDA Advisory Committee (AdCom) meetings
What happens to a stock on its PDUFA date?
2026 PDUFA calendar
Every upcoming FDA decision by month.
FDA decisions archive
Past approvals & CRLs.