Is the FDA approving drugs too fast?. Probably not--but drug recalls have sparked debate.
作者信息
Kleinke J D, Gottlieb S
出版信息
BMJ. 1998 Oct 3;317(7163):899. doi: 10.1136/bmj.317.7163.899.
Abstract
摘要
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Is the FDA approving drugs too fast?. Probably not--but drug recalls have sparked debate.美国食品药品监督管理局批准药物的速度太快了吗？可能并非如此——但药品召回引发了争论。
BMJ. 1998 Oct 3;317(7163):899. doi: 10.1136/bmj.317.7163.899.
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FDA approves drugs even when experts on its advisory panels raise safety questions.即使食品药品监督管理局咨询小组的专家们提出了安全问题，该局仍会批准药物。
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本文引用的文献
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Approval of new drugs in the United States. Comparison with the United Kingdom, Germany, and Japan.美国新药审批情况。与英国、德国和日本的比较。
JAMA. 1996 Dec 11;276(22):1826-31.
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