FDA GMP “Surveillance” Will Link Quality, Compliance Information To Inspections
Executive Summary
CDER’s Woodcock says the new database will drive risk-based inspection decisions.
You may also be interested in...
US FDA Quality Metrics Initiative Continues Moving Forward … Quietly
Despite few public announcements and industry concerns, FDA's Office of Pharmaceutical Quality director says program is not dead.
Woodcock's Legacy: CDER Organizational Improvements
In interview with the Pink Sheet, Center for Drug Evaluation and Research director discusses her 30-year career, retirement speculation, and upcoming projects.
Generic Drug Review Costs Still Largely Non-Personnel Related
Despite a recent hiring binge, FDA's ANDA evaluation expenses continue to be driven by infrastructure and equipment.