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Another ANDA Submission Surge Begins

Executive Summary

US FDA receives more than 100 ANDAs during the first month of GDUFA year five, suggesting sponsors want the new 10-month review goal and cheaper user fee.

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There's The Bolus! ANDA Sponsors Race To Avoid User Fee Spike

In a year defined by application surges, more than 200 ANDAs were submitted in September, the last month of fiscal year 2017, likely to avoid paying a much higher application fee instituted Oct. 1.

There's The Bolus! ANDA Sponsors Race To Avoid User Fee Spike

In a year defined by application surges, more than 200 ANDAs were submitted in September, the last month of fiscal year 2017, likely to avoid paying a much higher application fee instituted Oct. 1.

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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