Will PDUFA VI Fee Structure Changes Slow Revenue Growth?
User fee revenue expected to break $1bn threshold by FY 2020, but growth looks to be slower than last few years.
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Sponsor preferred a tropical disease voucher because it could be redeemed for a supplemental application, but the FDA awarded a voucher under the medical countermeasures program, which prohibits redemption for supplements; agency says it takes a case-by-case approach to deciding whether tropical disease and rare pediatric disease vouchers can be redeemed for supplements.
Sponsor representatives also want postmarketing discussions moved to earlier in the assessment cycle.
Prescription drug user fee "receivables" nearly doubled in FY 2018, but the US FDA is not worried.