As GDUFA Launch Nears, Is Sitting In The Backlog More Appealing?
This article was originally published in The Pink Sheet Daily
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.
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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.
The agency was expecting many pending generic drug submissions to be withdrawn because sponsors would not want to pay the one-time backlog fee, but instead saw a substantial increase near the end of FY 2012.
The new user fee programs for generic and biosimilar products may need to be authorized retroactive to 2011 in order to be collected should federal budget sequestration take place.