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PDUFA application fees

This article was originally published in The Tan Sheet

Executive Summary

Fees for FY 2003 are: $533,400 for an application requiring clinical data; $266,700 for an application not requiring clinical data or a supplement requiring clinical data; $209,900 for establishment fees; and $32,400 for product fees. Fees for FY 2002 were $313,320 for applications requiring clinical data and $156,660 for those not requiring data or supplements requiring clinical data. The 2003 application fees are an increase of 70% over FY 2002...

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