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FDA Floats OTC Monograph Overhaul To Be “More Agile And Responsive”

This article was originally published in The Rose Sheet

Executive Summary

The agency will conduct a public hearing March 25-26 to garner input on improving the OTC monograph process, which currently faces “significant challenges.” FDA’s proposals include expanding the process for allowing deviations from formulations approved through NDAs and issuing monographs by administrative order.

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