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PDUFA Fees for FY ’08 Published

10/12/2007

Federal Register Notice: FDA is announcing the rates for prescription drug user fees for FY 2008. The rates for application fees for an application requiring clinical data is $1,178,000, for an application not requiring clinical data or a supplement requiring clinical data is $589,000, for establishment fees is $392,700, and for product fees is $65,030. These fees are effective on 10/1 through 9/30/08. To view this notice, click here.

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