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FDA noted that one of the incoming components used in its manufacturing is known to be high-risk for contamination and Sante relied on the supplier's certificate of analysis rather than conducting its own testing to ensure the component met requirements

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2017;35:30143014 American Society of Clinical Oncology (ASCO)

Among Phase 3 trials, reporting of results was completed in at least 60 percent of industry-funded and NIH-funded trials between 2008 and 2019, with trials funded by other federal agencies and other entities achieving lower reporting compliance