2007 年 FDA 修正案是否损害了药物研发？
Has the FDA Amendments Act of 2007 impaired drug development?
机构信息
B&D Consulting, Washington, DC, USA.
出版信息
Clin Pharmacol Ther. 2011 Feb;89(2):169-71. doi: 10.1038/clpt.2010.301.
Perched at the midpoint of "v.4" of the Prescription Drug User Fee Act (PDUFA-4), better known as the US Food and Drug Administration Amendments Act (FDAAA), it seems presumptuous to draw critical conclusions based on an "interim analysis" of this work in progress. Because drug development is a complex process measured in decades, one must rely on "surrogate markers" to impute FDAAA outcomes. Even so, there are many indications that the FDAAA has doused the fires of innovation, in scope, spirit, and interim results.
perched at the midpoint of "v.4" of the Prescription Drug User Fee Act (PDUFA-4), better known as the US Food and Drug Administration Amendments Act (FDAAA), it seems presumptuous to draw critical conclusions based on an "interim analysis" of this work in progress. Because drug development is a complex process measured in decades, one must rely on "surrogate markers" to impute FDAAA outcomes. Even so, there are many indications that the FDAAA has doused the fires of innovation, in scope, spirit, and interim results.
perched 意为“栖息”，而在文中，presumed 指的是“假定”，所以整个短语的意思是“假设”。in progress 是“在进行中”的意思。
因此，整句话的意思是：
在《处方药使用者付费法案》（PDUFA-4）的第 v.4 阶段的中途，也被称为《美国食品药品监督管理局修正案》（FDAAA），根据这项工作的临时分析来得出关键结论似乎是冒昧的。
因为药物开发是一个以数十年为单位的复杂过程，所以必须依靠“替代标志物”来推断 FDAAA 的结果。
即便如此，还是有很多迹象表明，FDAAA 在范围、精神和中期结果方面扼杀了创新之火。
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