FDA Resumes Quality Metrics Effort With Feedback And Site Visit Initiatives
FDA’s quality metrics initiative emerges from hibernation with a two-part feedback program and a site visit program. The agency plans to collect feedback on quality metrics in certain meetings conducted during the application process – and in a pilot program. Agency staff also plan to visit firms to learn how they use quality metrics.
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US FDA officials tell industry that implementing a quality metrics program is an agency priority and that a rejiggered program will incorporate various elements of other quality metrics initiatives being piloted by the agency, industry and academia.