Risk, responsibility, and generic drugs.

Risk, responsibility, and generic drugs.
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DOI:
10.1056/nejmp1208781
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发表时间:
2012-11-01
期刊:
The New England journal of medicine
影响因子:
--
通讯作者:
Greene JA
Greene JA
中科院分区:
其他
文献类型:
--
作者:
Kesselheim AS;Avorn J;Greene JA

文献摘要

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最高法院裁定,仿制药制造商不能因没有更新标签上的新警告而承担责任,这在后期出现的安全问题上留下了责任空白。一个关于药物不良事件的中央数据库可以帮助解决这个问题。
A Supreme Court ruling that generic-drug manufacturers can't be held liable for not updating their labels with new warnings leaves gaps in responsibility over late-arising safety issues. A central repository of data on adverse drug events could help address the problem.