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GDUFA II: Facility Fees Might Be Deferred Until ANDA Approval

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA appears willing to waive fees for some manufacturers until their first product is approved.

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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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US FDA Changes Data Source For GDUFA II Facility Fee Setting

Agency primarily uses application data instead of facility self-identification lists to determine FY 2018 generic drug user fees.

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