Facing the Inevitable: Being Prepared for Regulatory Requirements for Laboratory Developed Tests
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DOI: 10.1093/ajcp/aqy014
Abstract: Objectives We introduce regulatory terms, definitions, and the Quality System Regulation as proposed by the US Food and Drug Administration in the 2014 draft guidance entitled Framework for Regulatory Oversight of Laboratory Developed Tests and… read more here.
Keywords: developed tests; prepared regulatory; inevitable prepared; facing inevitable ... See more keywords