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FDA Puts LDT Guidance on Ice

by | Nov 25, 2016 | Laboratory Industry Report, Top of the News-lir

Whether you dreaded it or craved it, final guidance from the U.S. Food and Drug Administration (FDA) on laboratory-developed tests (LDT) will not be issued in December. The FDA confirmed that it will instead work with the new administration on appropriate reforms to ensure LDTs are safe and effective. According to a statement from the […]

Whether you dreaded it or craved it, final guidance from the U.S. Food and Drug Administration (FDA) on laboratory-developed tests (LDT) will not be issued in December. The FDA confirmed that it will instead work with the new administration on appropriate reforms to ensure LDTs are safe and effective. According to a statement from the…

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