FDA Official Makes Case In Favor of LDT Guidance

Despite criticism from clinical labs, he says FDA will continue to pursue regulation of LDTs

CEO SUMMARY: Forty years ago, pathologists in hospital and academic labs worked closely with treating physicians to produce laboratory-developed tests for discrete clinical cases. Seeing that, the FDA decided not to regulate those tests, an FDA official said. Over time, however, use of LDTs became a serious concern when labs developing LDTs were no longer involved …

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FDA Official Makes Case In Favor of LDT Guidance

Despite criticism from clinical labs, he says FDA will continue to pursue regulation of LDTs

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