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Without User Fees, OTC Monograph Changes Are Low Priority At FDA

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s work on time and extent applications and monograph updates is not supported by user fees, unlike its work in evaluating NDAs for some OTC drugs and for Rx products. 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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