Official Makes Case in Favor of FDA LDT Guidance

IN THIS EXCLUSIVE NEWS COVERAGE of a public appearance by a key FDA official, THE DARK REPORT provides lab executives and pathologists with a more nuanced understanding about the thinking behind the proposed FDA LDT guidance. Among the interesting insights are that FDA officials will not be surprised if some labs file a lawsuit challenging …

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Official Makes Case in Favor of FDA LDT Guidance

Despite criticism from clinical labs, he says FDA will continue to pursue regulation of lab-developed tests

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