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FDA Announces Two Initiatives to Inform Quality Metrics Program Development

FDA is announcing two new programs to gather feedback on the use of quality metrics to modernize pharmaceutical quality systems and advance innovation. These efforts, the Quality Metrics Feedback Program and the Quality Metrics Site Visit Program, build on stakeholder comments requesting continued dialogue on quality metrics, and provide ways for industry to engage the agency and inform FDA’s use of quality metrics. Feedback from early adopters, manufacturers who implemented quality metrics programs to address significant manufacturing problems, and independent academic research indicates that manufacturers’ overall quality programs benefit from an establishment’s quality metrics program. The new programs provide an opportunity for FDA to continue learning about the advantages and challenges companies have experienced in implementing quality metrics programs....[FDA]

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