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US FDA Agrees To CLIA Waiver Process Reforms, But More Is Needed, Coalition Says

Executive Summary

Despite FDA's efforts to centralize CLIA waiver reviews and bring more consistency to the process, one reform group tied to the diagnostics industry says the agency is not addressing the real problem: the fundamental standard for a waiver determination that FDA established in a 2008 guidance.

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Coming Together On CLIA Waivers? Industry Hopes To Recruit Patients, Providers To Push Reform

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