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At the time the protocols were finalized, trial results for SURPASS-CVOT were not yet available

The firm acknowledged that releasing OOS compounded preparations reflects a deviation from internal quality assurance procedures and obligation to notify patients and prescribers. But the FDA found that no corrective actions were provided to address the failure to notify patients and prescribers when OOS results were identified

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En siete de estos estudios, el objetivo principal fue la evaluacin de la eficacia glucmica, mientras que en el estudio restante el objetivo principal fue la evaluacin de la seguridad cardiovascular

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The longer youre on it, the more the costs accumulate