1. Pink Sheet

PDUFA Fees Forced Down For FY 2017 Due To Refund Provision

 
• By Derrick Gingery

Final year of this user fee cycle will include 14% discount, but agency says it is ready for revenue reduction.

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Prescription drug user fees will decrease dramatically in fiscal year 2017 thanks to a requirement forcing FDA to credit revenue in excess of estimates back to industry.

Fees for applications requiring clinical data will drop more than 14% compared to the FY 2016 level to $2.04m, the...

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