Our Life Sciences Regulatory & Compliance team has launched a new resource page, keeping you up-to-date on the latest regulatory developments affecting laboratory developed tests (LDTs). Our dedicated LDT page provides foundational materials, legislative and regulatory history, and updates and analyses regarding initiatives to increase oversight over LDTs, including FDA’s LDT Proposed Rule (October 2020).
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FDA’s Proposed Rule for Oversight of Laboratory Developed Tests: Part II: FDA’s Proposed Phaseout Policy – Key Considerations & Open Questions
FDA’s Proposed Rule for Oversight of Laboratory Developed Tests: Part I: Underpinnings of FDA’s Proposed Rule
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