Tag
lab-developed tests
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What journalists should know about lab-developed tests
In March, a federal court invalidated FDA regulations on lab-developed tests. Your audience needs to know the implications of this…
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FDA to regulate lab-developed tests, citing safety issues raised by journalists
News articles about lab-developed tests contributed to the FDA’s “growing body of evidence” that inaccurate tests threaten public health.
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Debate over regulating lab-developed tests about to heat up
Sometime this year, the U.S. Food and Drug Administration is expected to issue guidance to clinical laboratories that produce lab-developed…
