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Oxytrol Switch Showcases FDA’s New Benefit-Risk Framework – Soller

This article was originally published in The Tan Sheet

Executive Summary

Self-care expert Bill Soller says FDA approval of the Oxytrol for Women overactive bladder drug as an Rx-to-OTC switch “is a clear expression” of the agency’s qualitative benefit-risk framework for drug reviews, laid out in its recent PDUFA V Implementation Plan.

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