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FDAnews Drug Daily Bulletin
Aug. 2, 2012 | Vol. 9 No. 151
Show Us the Money: FDA Lays Out Fiscal 2013 User Fee Rates for PDUFA, BSUFA
Drugmakers must dole out nearly $2 million in fees for drug applications requiring clinical data in fiscal 2013, while companies submitting applications without such data, or supplemental drug apps, will need to fork over half that amount. The fees go into effect Oct. 1. The new rates, set to publish in the Aug. 1 Federal Register, also cover establishment fees — charged to certain facilities that produce drugs — and product fees for already approved drugs.
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