FDA 2016 User Fees Hold Steady For Brands, But Are Up – And Down – For Generics
PDUFA, BsUFA increase moderately, while GDUFA facility fees fall for the first time.
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User fee revenue expected to break $1bn threshold by FY 2020, but growth looks to be slower than last few years.
US FDA wants to use biosimilars for a demonstration of cloud-based technology, an idea mentioned to increase the use of real-time review and enhance data analysis.
The ideas could potentially address sponsor concerns about the effects of slow reviews.