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FDA Cannot Claim Regulatory Authority Over LDTs – But Labs Must Be Mindful, and Public Health Remains a Priority

by admin | Aug 24, 2020 | News

FDA Cannot Claim Regulatory Authority Over LDTs – But Labs Must Be Mindful, and Public Health Remains a Priority On August 19, 2020, HHS settled a debate that began nearly 30 years ago: FDA cannot regulate laboratory developed tests (LDTs) until and unless the agency...

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