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Home » Medical Testing Methods Subject of Two Draft Guidances
Medical Testing Methods Subject of Two Draft Guidances
September 8, 2006
The FDA issued two draft guidances Sept. 7 on medical testing: one covering a new type of medical test called in vitro diagnostic multivariate index assays (IVDMIAs), and the other clarifying the rules for commercially distributed active ingredients of medical tests called analyte specific reagents (ASRs).