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“No End In Sight” For Completing OTC Monographs – CDER Director Woodcock

This article was originally published in The Rose Sheet

Executive Summary

Janet Woodcock says FDA expected when the process was launched to complete all monographs by the year 2000, but 25 remain in tentative final monograph status, with a rulemaking required to finalize each one. “The rulemaking process … doesn’t work for getting monographs done in a very timely manner,” she says.

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