FDA announces two initiatives to modernize drug quality programs – APhA submits compounding comments to FDA. – (866) 348-2889.
FDA unveiled on Thursday two new voluntary programs, the Quality Metrics Feedback Program and the Quality Metrics Site Visit Program. The programs were developed in response to stakeholder requests for ongoing dialogue about quality metrics, and to give industry ways to engage and inform FDA’s use of them in the future. Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, and Michael Kopcha, PhD, RPh, director of the Office of Pharmaceutical Quality, FDA’s Center for Drug Evaluation and Research, note the “programs will also help drug manufacturers to gain a better understanding of how quality metrics are a common feature of quality culture, and support improvements in product and process quality.”