News for Healthier Living
Video and Transcript Available - FDA Changes to Laboratory Developed Test Regulation: Livestreamed Expert Panel
Live from the annual conference of the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC), experts will discuss how the new FDA rule on laboratory developed tests will hinder patient care. This rule will place these tests under duplicative FDA oversight, even though laboratory developed tests are already regulated by the Centers for Medicare & Medicaid Services. This will force many labs to stop performing these essential tests, which play a critical role in diagnosing rare disorders, such as inherited genetic conditions in newborns.
August 5, 2024
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