FDA report outlines approach to personalized medicine
In a detailed new report, the U.S. Food and Drug Administration has outlined its approach for regulating new personalized therapies and devices. The report, Paving the Way for Personalized Medicine: FDA's Role in a New Era of Medical Product Development, outlines the fundamental ways in which the FDA has modified its traditional approaches to drug and device regulation in the new era of products that are tailored toward specific patient subtypes, rather than broad diagnostic groups.
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