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FDA's Proposed Rule on Laboratory Developed Tests: One Small Change to Regulatory Language That Would Mark a Giant Leap in Lab Testing Regulation | Akin Gump Strauss Hauer & Feld LLP

On October 3rd, the Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). Last year, Congress failed...
Akin Gump Strauss Hauer Feld Development Act Drug Administration Public Health Rationale Veterans Health Administration Clinical Laboratory Improvement Amendments

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