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Personalized Medicine Food and Drug Administration (FDA) Genetic Testing

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Collaborative Review of Scientific Evidence Announced By FDA

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Personalized medicine selects the best therapy or course of treatment for each patient based on diagnostic testing. In one aspect, personalized medicine uses pharmacogenetic testing to provide information regarding: 1) how an...more

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The Era of Personalized Medicine Has Arrived - PMC’s Annual Progress and Outlook Report

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The Personalized Medicine Coalition (PMC) released its annual “Personalized Medicine At FDA: A Progress & Outlook Report” (Report) that monitors current successes and challenges in bringing personalized therapies to market....more

Mintz - Health Care Viewpoints

Genetic Testing, Genome Sequencing, and the FDA

In recent years, the Food and Drug Administration has been struggling with how to adapt the regulatory paradigm for in vitro diagnostic devices (IVDs) – any test that detects a disease, condition, or infection – to the...more

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Three Pressing Challenges for Personalized Medicine

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Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

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