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ANDA Holder Fee Will Start With Industry-Driven Database 'Clean-Up'

Executive Summary

FDA is again relying on sponsor self-reporting as it launches GDUFA II.

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Inside The ANDA Parking Lot

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?

Inside The ANDA Parking Lot

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?

Generic User Fee Hikes Could Disrupt US FDA Drug Pricing Campaign

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

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