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Without User Fees, FDA’s Monograph Review Process Lacks Manpower

This article was originally published in The Rose Sheet

Executive Summary

FDA’s work on time-and-extent applications and monograph updates, unlike its work in evaluating NDAs for some OTC drugs and for Rx products, is not supported by user fees. The difference shows in the stalled process for approving new monograph ingredients, says the acting head of FDA’s OTC drugs office.

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