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And so FDA is going to need to use a different lens. Unlike FDA approval of a new drug, which requires years of clinical trials demonstrating safety and effectiveness, placement on the 503A Bulks List answers a different regulatory question
Fourman LT, Stanley TL, Billingsley JM, et al
Attempts to increase exposure to UA have been made previously in the context of ischaemic stroke, one study finding that fewer patients underwent early ischaemic worsening after intravenous UA administration 54
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