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

 
• By Derrick Gingery

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.

FDA entrance sign 2016

The anticipated bolus of ANDAs from sponsors wanting to avoid a substantial increase in user fees waited until September to manifest. But it arrived nonetheless, and will likely complicate FDA's workload for the coming year.

FDA reported receiving 202 ANDAs in September, the last month of fiscal year 2017. It was the second-highest monthly total...

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