FDA in Drafting Phase for LDT Oversight | GenomeWeb

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration is currently drafting its plans for regulating laboratory-developed tests and is considering available options, such as using a risk-based approach for oversight and a registry of tests to know what services are available, an FDA official told the Secretary's Advisory Committee for Genetics, Health, and Society today.

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