Priority Review
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
Priority Review is an FDA designation shortening the standard application review goal from ten months to six months for a drug that, if approved, would provide a significant improvement in safety or effectiveness for a serious condition. It changes the review timeline commitment under FDA’s user-fee performance goals, not the evidentiary standard the application must meet.
The designation is decided within 60 days of the original application filing, based on whether the drug offers a significant therapeutic advance — compared to a standard review, which applies by default whenever a submission does not meet the significant-improvement bar for priority handling.
Priority Review vouchers are a related but separate incentive: FDA’s rare pediatric disease and tropical disease programs award a transferable voucher entitling the holder to priority review of a future, unrelated application — vouchers created this way have been bought and sold between companies for substantial sums.
- —Shortens the FDA review goal from 10 months to 6 months for the application
- —Based on significant improvement in safety or effectiveness for a serious condition
- —Changes the review timeline commitment, not the evidence required for approval
- —Priority review vouchers (rare pediatric/tropical disease programs) are a separate, transferable incentive
FDA guidance “Expedited Programs for Serious Conditions — Drugs and Biologics” (2014); PDUFA reauthorization performance goals letters
Frequently asked questions
What is Priority Review?
Priority Review is an FDA designation shortening the standard application review goal from ten months to six months for a drug that, if approved, would provide a significant improvement in safety or effectiveness for a serious condition. It changes the review timeline commitment under FDA’s user-fee performance goals, not the evidentiary standard the application must meet.
Which regulations cover Priority Review?
FDA guidance “Expedited Programs for Serious Conditions — Drugs and Biologics” (2014); PDUFA reauthorization performance goals letters