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COVID-19 Demands Merit A Mention In US FDA's PDUFA Fees Notice For FY 2021

 
• By Derrick Gingery

The pandemic's impact was mentioned only in FDA's calculations for fees including those established by PDUFA. In addition to prescription drug applications, PDUFA fees are charged for OTC switch applications and other proposals for ingredients that are not part of an OTC monograph to be made available nonprescription.

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The US Food and Drug Administration announced its fiscal year 2021 user fees, and in many cases drug application sponsors will see discounts compared to FY 2020.

The impact of the coronavirus pandemic was mentioned only in the calculations for fees including those established by the Prescription Drug User Fee Act

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