Generic Industry Consolidating But Still Mysterious
Executive Summary
Nearly 2,000 ANDAs remain unclaimed as US FDA begins fee calculations for GDUFA II.
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GDUFA II: More Than 2,000 ANDAs Remain Unclaimed, Large Firms Still Dominate
Firms could find themselves charged multiple US generic drug user fees if affiliates are not identified and ANDAs claimed.
ANDA Holder Fee Will Start With Industry-Driven Database 'Clean-Up'
FDA is again relying on sponsor self-reporting as it launches GDUFA II.
GDUFA II: ANDAs, Not Facilities Will Govern Revenue
Since applications comprise most of the workload, they will be the focus in the next generic drug user fee cycle.