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FDA To Create Quality Metrics To Help Fine-Tune Risk-Based Enforcement

This article was originally published in The Tan Sheet

Executive Summary

FDA will work with stakeholders to identify quality indicators that drug firms would track and report to help the agency improve surveillance and fine-tune risk-based criteria for inspections and enforcement, FDA’s Sklamberg said. CDER’s Office of Compliance also is focused on improving supply chain oversight and clarifying contract manufacturer responsibilities.

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