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Se requiere monitorizacin en pacientes con insuficiencia renal, aunque no se requieren ajustes de dosis especficos por funcin renal

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The agency explained that the informal adjudication process is more consistent with its drug shortage authority than with rulemaking because the agency is applying the statutory standard for drug shortages to the relevant facts here, where such application does not create new law, and because the temporary nature of drug shortage determinations

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