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美国和英国的药品监管:醋酸甲羟孕酮案例

Drug regulation in the United States and the United Kingdom: the Depo-Provera story.

作者信息

Richard B W, Lasagna L

出版信息

Ann Intern Med. 1987 Jun;106(6):886-91. doi: 10.7326/0003-4819-106-6-886.

Abstract

In 1984, both the United Kingdom and the United States received recommendations from panels of experts specifically convened to consider the merits of Depo-Provera (depot medroxyprogesterone acetate [DMPA]) as a long-term contraceptive agent. This study compares the final reports written by these panels. We explore why, despite access to essentially the same data, the U.K. panel recommended marketing approval but the U.S. Public Board of Inquiry did not. We conclude that differing national policies helped shape the interpretation of the data and thus the divergent outcomes.

摘要

1984年,英国和美国都收到了专门召集的专家小组的建议,这些专家小组旨在审议醋酸甲羟孕酮长效避孕针(Depo-Provera,即醋酸甲羟孕酮[DMPA])作为长效避孕剂的优点。本研究比较了这些专家小组撰写的最终报告。我们探讨了为什么尽管获取的数据基本相同,但英国专家小组建议批准上市,而美国公共调查委员会却没有。我们得出结论,不同的国家政策有助于形成对数据的解读,从而导致了不同的结果。

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