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Reinventing OTCs: FDA Seeks New Models; Stakeholders Urge Renewed Focus

This article was originally published in RPM Report

Executive Summary

FDA convened a two-day hearing to solicit new ideas to replace the OTC drug monograph system as part of a broader look at ways to enhance the regulatory model for OTCs. However, the architects of the process strongly urged FDA not to overhaul the system – but instead focus more attention on it. At stake is whether FDA makes an all out push to increase OTC switches in coming years.

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