Priority Review Vouchers Post Lower Average Approval Times Than Priority NMEs
US FDA’s priority review voucher program delivers for most sponsors, a Pink Sheet analysis finds; PRVs reliably produce faster approval than priority-reviewed new drugs overall.
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Unless reauthorized by Congress, the rare pediatric disease program will begin to expire in September; renewal could bring bigger changes across the three PRV programs, including an FDA-requested clarification of biologic products eligible for vouchers and reforms suggested by sponsors and other stakeholders in a recent GAO report.
US FDA’s Medical Countermeasures Initiative authorities like emergency use authorization have not yet had much of an impact on drugs and biologics, but agency is committed to supporting a swift response to the new strain of coronavirus.
With the addition of BLU-782 to its soon-to-be filed fibrodysplasia ossificans progressiva drug palovarotene, Ipsen hopes to expand treatment options for patients with the rare bone disease.