Elizabeth Caruso

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FDA’s Proposed Rule for Oversight of Laboratory Developed Tests: Part I: Underpinnings of FDA’s Proposed Rule

On October 3, 2023, the U.S. Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). The proposed rule and policy are the latest in an over...more

10/9/2023  /  Clinical Laboratories , Comment Period , Diagnostic Tests , Food and Drug Administration (FDA) , Laboratory Developed Tests , Medical Devices , Proposed Rules , Regulatory History , Regulatory Oversight

The ABCs of DCTs: New FDA Guidance Provides Recommendations for the Conduct of Decentralized Clinical Trials

On May 2, 2023, the U.S. Food and Drug Administration (“FDA”) published draft guidance titled “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” (the “Draft Guidance”). ...more

5/10/2023  /  Clinical Trials , Comment Period , Digital Health , Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Medical Research , Pharmaceutical Industry , Prescription Drugs
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