Is ANDA Bolus Coming As Higher User Fees Loom?
Generic submission volume remained steady in August as some wonder whether sponsors will rush to avoid a 144% increase in the ANDA user fee taking effect Oct. 1.
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Generic User Fee Hikes Could Disrupt US FDA Drug Pricing Campaign
New GDUFA program fee is high enough that sponsors may withdraw applications to reduce their fee exposure, agency estimates.
ANDA Approvals Break Record, May Set New Normal
FDA's June approval total is highest of GDUFA era, but does it signal a new elevated productivity level for the generics program?
Generic Drugs: First-Cycle Review Times Improve, But Hundreds Of ANDAs Still Pending
US FDA cut first-cycle review time 46% between fiscal year 2013 and FY 2015, but more than 900 ANDAs still awaited review by end of 2016.