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QUOTED. 23 September 2020. US FDA

Executive Summary

Tests used to detect cytomegalovirus in organ transplant patients may face an easier path to market under a proposed rule that the US Food and Drug Administration released on 18 September. See what the regulatory agency said about it here.

“Health care professionals managing transplant patients with CMV DNAemia or CMV infection often have substantial clinical experience with quantitation of CMV DNA such that patient risks are reduced when these tests are used for clinical management.” – US FDA

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