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CDER Office of Pharmaceutical Quality Launches; Initial Impact On Manufacturers Is Minimal

This article was originally published in RPM Report

Executive Summary

FDA completed a major reorganization of the way it regulates manufacturing quality of drugs and biologics with the launch of the Office of Pharmaceutical Quality within the Center for Drugs. OPQ is part of Janet Woodcock’s decade-long effort to ensure a consistent, safe drug supply. The immediate impact on industry will be minimal, but manufacturers that haven’t invested in facility upgrades will face a steep learning curve.

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