I’ve been blogging about FDA Commissioner Markay’s National Priority Voucher program since it was announced in June 2025 (here, here, here, here, and here). In these blogs, I’ve raised the following concerns: The compressed one- to two-month timeframe creates a potential opportunity for missing something important during these reviews. With the competition for resources for […]
“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 designation under section 506H of the FD&C Act.” These […]
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 […]
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 […]
If you are, or plan to be a sponsor of a Generic ANDA, do not let this slip by you. The FDA on January 30, 2020 revised its Manual of Policies and Procedures (MAPP) 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements to make changes to the prioritization scheme for the review […]
