PDUFA Becomes US FDA's Billion Dollar Baby
Second consecutive year of record workload levels drive substantial increase in FDA's prescription drug user fee revenue target for fiscal year 2019.
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Biosimilar development programs also are expected to increase, a promising sign for the growing sector, but those fees remained unchanged.
Prescription drug user fee "receivables" nearly doubled in FY 2018, but the US FDA is not worried.
The PDUFA revenue inflation adjustment was higher than the workload adjustment for the first time in seven years.