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CVM Improves Its Cumulative Adverse Drug Experience Summaries Website

机译:CVM改进了其累积的不良药品经历总结网站

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There is a new look to the "Cumulative Adverse Drug Experience Summaries" on the Center for Veterinary Medicine's (CVM) website. The revised format should improve readers' interpretation of adverse drug experiences associated with specific animal drugs. New animal drugs are evaluated for safety and effectiveness before they are approved by the Food and Drug Administration (FDA). However, testing is done in a limited number of animals and in controlled settings. Less common adverse drug events that could arise during real-world usage might not be detected during pre-approval testing. CVM scientists use reports of adverse drug experiences (ADE) to monitor a new animal drug after it is approved. The ADE reports are assembled into an ADE database. The ADE database helps CVM scientists decide whether there should be changes to product labeling or other regulatory action.
机译:兽药中心(CVM)网站上的“累积不良药物经历摘要”有了新的外观。修订后的格式应改善读者对与特定动物药物有关的不良药物经历的解释。在获得美国食品药品监督管理局(FDA)批准之前,对新动物药进行安全性和有效性评估。但是,测试是在有限数量的动物和受控环境中进行的。在实际使用期间可能会发生不太常见的不良药物事件,而在批准前的测试中可能无法检测到。 CVM科学家使用不良药物经历(ADE)的报告来监视新动物药物的批准。 ADE报告被组装到ADE数据库中。 ADE数据库可帮助CVM科学家确定是否应更改产品标签或其他监管措施。

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