Priority review


Quarterly Reporting Requirements for Priority Review Applications and Competitive Generic Therapy Posted Today

As the FDA notes, “Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs) subject to priority review under section 505(j)(11) of the Federal Food, Drug, and Cosmetic (FD&C) Act and certain ANDAs with a competitive generic therapy (CGT) designation under section 506H of the FD&C […]

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FY 2022 Fees for Using Priority Review Vouchers Announced 

Today’s prepublication of the Federal Register (FR) contains the fees to be assessed for three priority review vouchers, namely the material threat medical countermeasure (MCM) priority review voucher; the rare pediatric disease priority review voucher, and the tropical disease priority review voucher.  These fees were announced in three separate FR notices (here, here, and here).  These vouchers are awarded to sponsors that submit and […]

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