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首页> 外文期刊>Pediatrics: Official Publication of the American Academy of Pediatrics >IOM Review of FDA-Approved Biologies Labeled or Studied for Pediatric Use
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IOM Review of FDA-Approved Biologies Labeled or Studied for Pediatric Use

机译：IOM对FDA批准的标记或研究用于儿科用途的生物的审查

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BACKGROUND: Studies have examined the extent to which public policies such as the Best Pharmaceuticals for Children Act have increased pediatric information in drug labeling. Little attention has focused on pediatric labeling of biologies. This analysis examines the extent to which biologies are labeled for pediatric use or have been studied in children.METHODS; The analysis covers the 96 biologies (excluding vaccines) that were first licensed by the Food and Drug Administration between 1997 and 2010 and were still marketed as of 2010. Product labeling was consulted for information on approved pediatric uses, pediatric studies, or pediatric safety warnings based on analyses of adverse events. The online database ClinicalTrials.gov was searched for registered pediatric studies of these biologies. A separate analysis examined labeling and studies for 55 vaccines.RESULTS: For ~60% of the 96 biologies, labeling shows approved pediatric use or pediatric study information or both. Approximately 85% of the biologies have >=1 registered pediatric trial completed, underway, or planned. Overall, -90% are labeled for pediatric use, have pediatric information in the label, have a registered pediatric study, or have some combination of these characteristics. For the 55 analyzed vaccines, the corresponding figure is 95%.COiCLUSliiS: A majority of biologies approved in the past 15 years include some pediatric information in their labeling, and pediatric trials have been registered for a substantial majority, of these products.
机译：背景：研究检查了诸如“儿童最佳药品法”之类的公共政策在多大程度上增加了药品标签中的儿科信息。很少关注集中在小儿生物标签上。该分析检查了将生物学标记为儿科用途或已在儿童中进行研究的程度。该分析涵盖了1997年至2010年间首次获得美国食品药品监督管理局（FDA）许可并于2010年上市的96种生物制剂（不包括疫苗）。已咨询产品标签以获取有关已批准的儿科用途，儿科研究或儿科安全警告的信息。基于对不良事件的分析。在在线数据库ClinicalTrials.gov上搜索了这些生物学的注册的儿科研究。一项单独的分析检查了55种疫苗的标签和研究结果。在96种生物制剂中，约60％的标签显示已批准的儿科用途或儿科研究信息，或两者兼而有之。大约85％的生物制剂已完成，正在进行或计划中的注册儿科试验> = 1。总体而言，-90％的标签被标记为用于儿科，在标签中包含了儿科信息，已注册了儿科研究，或具有这些特征的某种组合。对于分析的55种疫苗，对应的数字为95％。用途：过去15年中批准的大多数生物制剂在其标签中都包含一些儿科信息，并且这些产品中的绝大部分已注册了儿科试验。

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