评估与PREA安全豁免相关的FDA标签变化
Jason Krastein1, Denise Pica-Branco1, Matthew A Bacho1
1Division of Pediatrics and Maternal Health, Office of Rare Diseases, Pediatrics, Urologic, and Reproductive Medicine, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Therapeutic innovation & regulatory science
|June 30, 2023
概括
美国食品和药物管理局 (FDA) 始终在药物标签中包括安全信息,当根据"儿科研究公平法案" (PREA) 放弃儿科研究时. 这确保了关于儿科药物安全性的透明度.
科学领域:
- 药物监督 药物监督 药物监督
- 监管科学 监管科学
- 儿科药物开发 儿科药物开发
背景情况:
- 儿科研究公平法案 (PREA) 要求对药物和生物制剂进行儿科研究.
- 在特定情况下,PREA允许放弃这些研究,包括安全问题.
- 当安全豁免被授予时,PREA要求在产品的标签上记录识别的安全问题.
研究的目的:
- 评估与PREA豁免相关的安全信息被纳入药物和生物标签的速度.
- 评估随着时间的推移,关于儿科安全豁免信息的标签实践的一致性.
主要方法:
- 对2003年12月至2020年8月期间发布的与安全相关的儿科研究豁免的FDA数据库的审查.
- 分析相应的产品标签,以确定是否包括与豁免相关的安全信息.
- 在四个不同的时间群中进行描述性比较 (2003-2007,2008-2011,2012-2015,2016-2020).
主要成果:
- 总共有116个安全豁免签发了84种独特的药物或生物制品.
- 绝大多数与豁免相关的安全问题 (91%) 包含在产品标签中.
- 安全豁免最常用于17岁以下的患者和抗感染产品.
结论:
- 自2003年12月PREA成立以来,FDA一直在药物和生物标签中包括与豁免相关的安全信息.
- 这表明他们对儿科药物安全信息的透明度有持续的承诺.
- 这些发现支持PREA对安全豁免的标签要求的有效性.
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