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Tracking The Priority Review Vouchers

Executive Summary

A chart showing the status of the 10 FDA priority review vouchers awarded to date for tropical disease and rare pediatric disease treatments.

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Gilead, With Two PRVs In Hand, Holds Options For Accelerating Late-Stage Pipeline

Likely candidates for use of Gilead's priority review vouchers include GS-4997, a Phase III candidate for NASH, and bictegravir, its second-generation integrase inhibitor for HIV. The virology specialist previously used a PRV successfully to accelerate approval of Odefsey.

Sponsors May Race For Rare Pediatric Voucher Designations As Deadline Nears

US FDA program's new 2020 sunset could create a bolus of designation requests to ensure they can still get a voucher if it ends.

Voucher Does Not Guarantee A Priority Review, FDA Says

Final guidance on the tropical disease priority review voucher program says FDA will adhere to priority review goals, which allow agency to complete some outside the stated time frame.

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