FDA Gets an Earful During Public Meeting on Guidance Document for IVD-MIAs

Feb 9, 2007 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Management & Operations

Yesterday’s public forum conducted by the Food and Drug Administration (FDA) on proposed guidance to regulate a certain category of molecular diagnostic assays drew a surprisingly large and diverse number of presentations and comments from the laboratory, biotech, and healthcare industries. When the FDA recently released two draft guidelines, one for commercially distributed analyte specific regents (ASRs) and another for IVD multivariate index assays (IVD-MIAs), it was hoping to address...
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