AMP Offers Proposal for Regulation of Laboratory Developed Tests
Last month in Compliance Perspectives, we highlighted the current status of the Food and Drug Administration’s proposed regulation of laboratory-developed tests (LDTs). While the FDA’s proposed framework remains to be finalized, other stakeholders are proposing alternative oversight models. This month, the Association for Molecular Pathology issued a proposal for modernizing CLIA regulations. The proposal reiterates […]
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