FDA Lays Out Some Fiscal 2013 Generic 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 Oct. 25. 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 were set on Oct. 25, it has until Nov. 24 to pay the fee.
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