Post-marketing drug assessment is now onset in our country, and the research is unsubstantial.

我国的药品上市再评价刚起步，在该领域的研究非常薄弱。

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Establishment of assessing model suitable to drug management is vital to settle post-marketing drugs.

因此建立适应药品管理的规范评价模式是再评价的重点，也是需要解决的难点。

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To identify the key points of post-marketing drug evaluation and provide technical support for related guidance.

探讨药物上市后评价的关注点，为药物上市后评价指导原则的构建提供技术参考。

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"While I don't think that a separate office for post-marketing surveillance is likely, a strengthened Office of Drug Safety is almost a certainty, " says David Kessler, a former FDA commissioner who is now a dean at the University of California, San Francisco.

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The FDA gave the drug accelerated approval, and Pfizer is conducting post-marketing clinical trials to further evaluate its clinical benefit.

FORBES: Bristol-Myers, Pfizer Announce Positive Results; An FDA Approval for Pfizer