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Priority review

Priority review is a designation granted by the United States Food and Drug Administration (FDA) to certain drug applications that, if approved, would provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.[1] Under this designation, the FDA aims to take action on an application within six months, compared with ten months under standard review.[1]

Manufacturers can apply to the FDA for priority review.[2] It is granted when a drug is intended to treat a serious condition and would "provide a significant improvement in safety or effectiveness" over currently available treatments.[2] Under current Prescription Drug User Fee Act targets, the FDA aims to complete and act upon reviews of priority drugs within six months instead of the standard ten-month review period.[3] Actual FDA review timelines can be longer than these targets, particularly for new products that have not previously been approved for any indication.[3]

Priority review does not omit safety or efficacy studies, and it does not require approval within a given time frame.[4] It sets a target of six months rather than ten for FDA review.[4] It should not be confused with accelerated approval or fast track designation.[4]

A priority review voucher can be used when a drug does not fit these requirements but the company wishes to expedite the review process.[5] Sponsors must inform the FDA of their intention to use a voucher 90 days before submission.[5] Companies that use a voucher must pay a supplemental priority review user fee in addition to the fee for standard review.[6] Because vouchers may be sold, a secondary market for them has emerged.[7]

Related: Breakthrough therapy designation, Accelerated approval, Fast track designation