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

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.

test tube

US FDA's process for reviewing test-waiver applications under the Clinical Laboratory Improvement Amendments (CLIA) is set to undergo enhancements based on a draft user-fee reauthorization agreement.

In the deal that was inked last month, the agency says it will establish a centralized management group for CLIA...

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GE HealthCare Announces US Launch Of Longer Half-Life PET MPI Agent For Ischemia Detection

 
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GE HealthCare is pursuing a dual-front imaging strategy with its PET MIP agent Flyrcado for detecting artery disease: It lasts longer than current PET scan tracers and allows patients to do treadmill-based stress tests alongside the scan.