Generic Drug User Fees Lower Than Expected, Thanks To Higher Volume
This article was originally published in The Pink Sheet Daily
Fiscal year 2013 fees for new ANDAs, prior approval supplements, backlogged applications and drug master files are 3%-50% below the agency’s initial projections.
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Manufacturers paying facility fees will shoulder most of the burden as GDUFA revenue is increased in FY 2014 for inflation and rebalanced to account for the loss of the backlog fee.
The agency was expecting many pending generic drug submissions to be withdrawn because sponsors would not want to pay the one-time backlog fee, but instead saw a substantial increase near the end of FY 2012.
More submissions are going into the generic drug backlog, likely because the backlog fee is expected to be less than half the GDUFA application fee.