Priority Review
An FDA designation shortening the review timeline from 10-12 months to approximately 6-8 months for drugs offering significant improvements in safety or effectiveness for serious conditions. Priority review accelerates the FDA's decision but does not change the evidence requirements for approval.
Technical Context
Priority Review criteria: the drug offers a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious condition compared to standard applications. Priority Review reduces the target review time from 10 months (standard) to 6 months from filing date. Priority Review Vouchers (PRVs) are awarded to companies that develop drugs for rare paediatric diseases or neglected tropical diseases — the voucher can be used for any subsequent application or sold to another company (PRVs have sold for $100-350M). Priority Review does not change the evidence standard — the drug still must demonstrate safety and efficacy. It only accelerates the FDA's internal review timeline. Most new peptide drugs with significant therapeutic advances receive Priority Review.