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HEPATITIS C RNA PANEL SHOULD BE DEVELOPED TO TEST NEW ASSAYS, PANEL SAYS; DCLD DEVELOPING GUIDANCE ON VARIOUS HEPATITIS A, B, C TESTS AND INDICATIONS

This article was originally published in The Gray Sheet

Executive Summary

FDA should develop a panel of hepatitis C virus RNA specimens to challenge new qualitative HCV RNA assays, the agency's Microbiology Devices Panel recommended at its Feb. 12 meeting in Gaithersburg, Maryland. The group was convened to assist FDA's Center for Devices and Radiological Health in efforts to develop a guidance that will prescribe clinical study guidelines for hepatitis A, B, or C tests for diagnosis and/or monitoring indications.
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