FDA’s Woodcock to Head Office of Pharmaceutical Quality; New Details Emerge
This article was originally published in RPM Report
FDA’s proposed Office of Pharmaceutical Quality will be initially headed by CDER Director Janet Woodcock. OPQ would hold responsibility over the manufacturing quality of a drug or biologics throughout a product’s lifecycle; eight offices will oversee activities from policy development to surveillance.
You may also be interested in...
Deputies are taking on some of Woodcock’s usual responsibilities to allow the center director more time to oversee launch of new Office of Pharmaceutical Quality.
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.
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.