RegulatoryGlossary Term
An FDA program that shortens the target time for reviewing a marketing application from the standard ten months to six months for drugs that offer significant improvements in safety or effectiveness for serious conditions.
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.
Application review
"The NDA for the novel antibiotic was granted Priority Review based on its activity against multi-drug resistant bacteria, reducing the FDA review goal from ten months to six months."
Priority Review Voucher
"Upon approval of the treatment for the rare pediatric disease, the sponsor received a Priority Review Voucher that could be used for a future application or sold to another company."
A premarket submission to the FDA demonstrating that a medical device is substantially equivalent to a legally marketed predicate device and therefore does not require premarket approval.
An FDA pathway allowing approval of drugs for serious conditions based on a surrogate endpoint or intermediate clinical endpoint reasonably likely to predict clinical benefit, with post-marketing requirements to confirm the expected benefit.
A regulatory submission to the FDA requesting approval to market a biological product in the United States, demonstrating that the product meets standards for safety, purity, and potency.
An FDA program for drugs intended to treat serious conditions where preliminary clinical evidence indicates substantial improvement over available therapies on clinically significant endpoints.
An FDA program designed to expedite the development and review of drugs intended to treat serious conditions and fill an unmet medical need, providing increased communication with FDA and eligibility for Rolling Review.
An FDA program that shortens the target time for reviewing a marketing application from the standard ten months to six months for drugs that offer significant improvements in safety or effectiveness for serious conditions.
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.
Application review
"The NDA for the novel antibiotic was granted Priority Review based on its activity against multi-drug resistant bacteria, reducing the FDA review goal from ten months to six months."
Priority Review Voucher
"Upon approval of the treatment for the rare pediatric disease, the sponsor received a Priority Review Voucher that could be used for a future application or sold to another company."
A premarket submission to the FDA demonstrating that a medical device is substantially equivalent to a legally marketed predicate device and therefore does not require premarket approval.
An FDA pathway allowing approval of drugs for serious conditions based on a surrogate endpoint or intermediate clinical endpoint reasonably likely to predict clinical benefit, with post-marketing requirements to confirm the expected benefit.
A regulatory submission to the FDA requesting approval to market a biological product in the United States, demonstrating that the product meets standards for safety, purity, and potency.
An FDA program for drugs intended to treat serious conditions where preliminary clinical evidence indicates substantial improvement over available therapies on clinically significant endpoints.
An FDA program designed to expedite the development and review of drugs intended to treat serious conditions and fill an unmet medical need, providing increased communication with FDA and eligibility for Rolling Review.