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

Executive Summary

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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