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FDA May Well Need OTC Drug Funding, But Stakeholders Want Program Specifics

This article was originally published in The Rose Sheet

Executive Summary

The monograph program was "instituted, really, many, many decades ago. We've been trying to implement it since," said CDER Director Janet Woodcock at a recent FDA hearing. While FDA drug leadership was candid in laying out a general case for industry user fees, stakeholders seek detail on how the additional funds would be used, among other specifics.

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