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PDUFA Workload Sets Records, But Inflation Generates More Revenue

 
• By Derrick Gingery

The PDUFA revenue inflation adjustment was higher than the workload adjustment for the first time in seven years.

White round tablets lie in front of President Franklin, who is depicted on a hundred-dollar bill. The concept of the high cost of medicine, pharmaceuticals. - Image
The workload and inflation adjustment formulas affect the PDUFA revenue target, which is used to set individual user fees. • Source: Shutterstock

Despite another year with record workload levels, the US Food and Drug Administration's prescription drug user fee program revenue was actually more affected by inflation.

For the first time in seven years, the FDA's inflation formula added more money to the prescription drug user fee revenue target than the workload formula, a surprising development given the agency devoted significant space in its user fee 

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