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US FDA lightens rules for diagnostics R&D that uses human specimens

This article was originally published in Clinica

Executive Summary

A new guidance under development at the US FDA will exempt diagnostics manufacturers from meeting patient-informed consent requirements when conducting studies that use only leftover human specimens that are not individually identifiable. The existing informed consent requirements "are bringing a halt to a class of very valuable research that can produce new diagnostic tests, without appreciably adding protection for human subjects," the agency said in a Federal Register notice on January 9.

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