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CDER Office of Product Quality Ready To Go: New Structure Sends Strong Signal To Industry

This article was originally published in RPM Report

Executive Summary

It took a while, but the Office of Pharmaceutical Quality is finally ready to begin operations. Biopharma companies should recognize the declaration of FDA’s priorities, and respond accordingly.

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FDA Pharmaceutical Quality ‘Super Office’ Launches With Integrated Reviews

CDER’s ‘super office’ aims to transform how industry thinks about manufacturing, but still needs to hire management and other staff.

FDA Pharmaceutical Quality ‘Super Office’ Launches With Integrated Reviews

CDER’s ‘super office’ aims to transform how industry thinks about manufacturing, but still needs to hire management and other staff.

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

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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