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FDA user fee plan

This article was originally published in The Tan Sheet

Executive Summary

Agency is authorized to collect $740 mil. in fees over five years, with $456 mil. of that to be used to maintain improvements, such as faster review times, wrought by the first Prescription Drug User Fee Act and to sustain 659 staff-years of program each year that made those improvements possible, according to the FDA PDUFA II five-year plan, whose availability FDA announced July 10. The remaining $284 mil. will be invested to enable FDA to meet the new PDUFA II goals, the agency says. CDER will receive 56% of the total. Of the overall monies, 58% will go for pay and benefits for additional agency staff (983 more staff-years, i.e., 325 more FTEs in 2002 than in the drug evaluation process in 1992) and 13% for information technology...

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