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Home » Medical Testing Methods Subject Of Two Draft Guidances
Medical Testing Methods Subject Of Two Draft Guidances
October 5, 2006
Medical test manufacturers should look for two recent FDA draft guidances: 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).