CDER’s New Quality Office Still Awaiting Final Sign Offs
This article was originally published in RPM Report
FDA’s proposed Office of Pharmaceutical Quality remains a personal and professional priority of CDER Director Janet Woodcock, and she determined to get the office up and running before the end of the fiscal year.
You may also be interested in...
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.
The Energy & Commerce Committee “21st Century Cures” Process promises to set a pro-innovation tone heading into the next user fee reauthorization cycle. There is one theme, however, that may be perilous for industry moving forward: Expanded Access.