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Its safety data come from small trials and a substantial body of anecdotal experience rather than the large, controlled trials that FDA-approved drugs require

This technological infrastructure must support rapid and optimal decision-making across the entire value chain, from product development to product marketing and pricing, to supply chain orchestration

This widespread use makes systematic monitoring essential to identify patterns that may not surface in smaller patient populations, as individual lab results contribute to a broader understanding of how real-world patients respond beyond controlled clinical trials

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