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ANDA Submissions To US FDA Expected To Decline; Generic User Fees For FY 2019 Will Rise

Executive Summary

FDA's predictions have been pretty consistent; actual submissions haven't been.

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A firm will take ownership of US ANDAs from manufacturers unwilling to pay program fees or withdraw the approved generic drug application; is it a novel concept allowing future marketing options or simply fee avoidance?

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Generic industry, FDA discuss potential ways to increase transparency so agency can better estimate when – and even whether – an ANDA receiving a complete response will be returned.

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New GDUFA program fee is high enough that sponsors may withdraw applications to reduce their fee exposure, agency estimates.

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