US FDA User Fees Offer Good And Bad News For Sponsors In FY 2020
Prescription drug user fees increase as many generic and biosimilar fees drop, as illustrated in our infographic.
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Prescription drug user fee "receivables" nearly doubled in FY 2018, but the US FDA is not worried.
Sponsors will pay 12% less to redeem a voucher in FY 2020, which is charged on top of the traditional PDUFA user fee.
The PDUFA revenue inflation adjustment was higher than the workload adjustment for the first time in seven years.