Generic User Fee Talks Reach 'Final Wording' But Still Not Done
FDA and industry say they have reached tentative agreement, but finance subgroup says more discussion needed.
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Generic drug reviews during the first year of formal review goals cost 70% more than during GDUFA's inaugural year.
Final GDUFA I application fees decrease amid expected boost in submissions, while facility fees will increase for the fourth time in five years.
User fee revenue expected to break $1bn threshold by FY 2020, but growth looks to be slower than last few years.