FDA Builds Quality Dashboard To Focus CMC Reviews And Inspections On Greatest Risks
A dashboard tool US FDA is developing promises to liberate key information from the agency’s trove of CMC review documents, enabling greater consistency among reviews and a greater emphasis on the manufacturing issues that pose the greatest risks.
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US FDA will establish mandatory quality metrics reporting through a formal rulemaking process that could take years. Meanwhile, a revised draft guidance lays out plans for voluntary quality metrics reporting that could begin by January 2018.
A risk-ranking pilot went so well that FDA’s Office of Generic Drugs has swiftly expanded use of the technique to help focus the attention of reviewers, swamped by GDUFA deadline-studded, QbD-packed ANDAs, on the quality issues that will have the greatest impact on patient safety.