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These include high costs, variability in the quality and engraftment efficiency of human liver tissue, the limited lifespan of human hepatocytes in the mouse liver, and incomplete reconstitution of the human immune system

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9711, otherwise known as the Food and Drug Administration Act of 2009, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited