The FDA issued a News Release (here) that provides some additional information about the program. “‘Using a common-sense approach, the national priority review program will allow companies to submit the lion’s share of the drug application before a clinical trial is complete so that we can reduce inefficiencies. The ultimate goal is to bring more […]
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 […]
In a pre-publication notice today, FDA announced the FY 2021 fee for the use of a Tropical Disease Priority Review Voucher, Rare Pediatric Disease Priority Review Voucher, or a Material Threat Medical Countermeasure Priority Review Voucher. That fee is $1,360,879 and remember that is to be paid on top of the $2,875,842 applications user fee […]
