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FDA s Final Rule and LDT Regulation Shift

FDA s Final Rule and LDT Regulation Shift
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FDA Makes Good on Its Promise to Regulate Laboratory-Developed Tests | Sheppard Mullin Richter & Hampton LLP

Yesterday, the Food & Drug Administration (“FDA” or “the Agency”) issued a highly anticipated – and highly controversial – final rule, which rolls out a four-year, five-stage plan that.

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FDA tightens scrutiny of lab-developed tests with new rule

The Food and Drug Administration (FDA) on Monday tightened regulations for clinical laboratories with a new rule that gives it more oversight of diagnostic tests developed by them.

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FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests - Oskaloosa News

FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests - Oskaloosa News
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US FDA Issues Final Rule on LDTs as Medical Devices

US FDA Issues Final Rule on LDTs as Medical Devices
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