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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?

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