An FDA spokeswoman defended the agency's handling of the review, saying that "overall, this is the most transparent manner ever used for a new animal drug application."

一个FDA的发言人这样为FDA的立场辩护：“说到底，这已经是一个新的兽药申请审批中从没有过的透明度了。”

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AIM: To introduce the concept of bridging study and its strategies in clinical trials for new drug application.

目的：介绍新药临床试验中桥接试验的概念和实施策略。

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Objective: To study the macrolide antibiotic adverse reaction and safety of drug application.

目的：探讨大环内酯类抗生素的不良反应及用药安全性。

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Merck and Schering-Plough filed a new drug application for Zetia with the FDA in December 2001.

FORBES: Schering-Plough And Merck's New Hope

The gamble paid off, as Merck was able to file a new-drug application six weeks before Novartis.

FORBES: Health

All signals point to this being one of the best times to submit a new drug application in years.

FORBES: Why Presidents Don't Shape The FDA