Priority Review represents the final stage of expedited development, accelerating FDA review of the marketing application for drugs that offer meaningful advances over available treatments for serious conditions. While other expedited programs focus on the development phase, Priority Review addresses the regulatory review period, reducing the target action date from ten months to six months for standard original applications. This accelerated review can bring important new treatments to patients up to four months sooner than standard review timelines.

The criteria for Priority Review focus on whether the drug represents a significant improvement in safety or effectiveness compared to available therapy for a serious condition. The assessment considers the proposed drug's complete profile, including efficacy, safety, and practical advantages such as reduced treatment burden or improved convenience. Drugs do not need to demonstrate superiority in controlled trials but must offer clinically meaningful benefit that justifies expedited review. Priority Review can be combined with other expedited programs and is frequently granted to products that have received Fast Track or Breakthrough Therapy Designation.

Priority Review affects only the FDA review phase and does not change the standards for approval or the evidentiary requirements that must be met. The agency must reach the same determinations regarding safety and effectiveness regardless of whether the review is standard or priority. The compressed timeline requires prioritization of agency resources and intensive reviewer engagement. Priority Review Vouchers, transferable awards granted for approval of drugs for neglected tropical diseases and rare pediatric diseases, provide additional incentives for development in underserved therapeutic areas by allowing holders to obtain Priority Review for any subsequent application.