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FDAnews Drug Daily Bulletin
Oct. 26, 2012 | Vol. 9 No. 211
FDA Lays Out Some Fiscal 2013 Generic Drug User Fee Rates; ANDAs to Cost About $50K
ANDA filers that have submitted an application on or after Oct. 1 must pay $51,520 in user fees, according to the FDA’s 2013 generic drug user fee rates announced Wednesday. Prior approval supplement (PAS) filers will owe the FDA half as much as ANDA filers, or $25,760. Fees are due on the date of submission; however, if an ANDA or PAS filer submitted an application before the fees are formally set on Thursday, it has until Nov. 24 to pay the fee.
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