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2014-11-24 Lachman CONSULTANTS

我们进入2015财年已近两个月，这是GDUFA指标的第一年，但你是否注意到10月份的仿制药计划的“行动报告”还没有发布？据我们了解，在GPhA（仿制药协会）秋季技术研讨会上Woodcock博士指出新的OGD/CDER IT平台存在一些问题，或许这就是罪魁祸首。

不知“行动报告”何时能够再次上线，但缺少获取数据的途径肯定让企业在GDUFA指标的第一年理清和跟踪OGD（仿制药办公室）的进展时更加焦心。尽管人们仍可以在另外的CDER网页查看每日更新的批准数量（顺便说一句，本月到11月23日为止仅有8件ANDA获得批准），而完全回应函的数量、ANDA接收量和其它包含在每月行动报告中的关键信息的访问似乎将被搁置，需等待IT人员在新的IT平台下找到如何产生这些报告。看起来新的IT平台可能有些不稳定。

直到新报告可以开始访问，OGD的透明度窗口又多关闭了一些。希望这个临时的小故障能够迅速得以解决，以使得行业能够一窥OGD的效率。

Lachman CONSULTANTS - Bob Pollock先生 2014-11-24
编译：识林-椒 2014-11-24

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Transparency Window Shuts Further At OGD – Hopefully Only Temporarily
Written by Bob Pollock • November 24, 2014

We are almost two months into FY 2015 and the first year of metrics for GDUFA, but have you noticed that the Generics Activity Report of the Generic Drug Program has not yet published for the October? As we understand it, the new OGD/CDER IT platform, noted by Dr. Woodcock as having some problems at the GPhA Fall Technical Workshop, is perhaps the culprit.

It is not known when the Activity Report will be published again, but the lack of access to its data certainly will give industry more heartburn when trying to make sense and track OGD's progress in year one of the GDUFA metrics. While one can still view the number of approvals updated daily on a different CDER web site (oh, and by the way, so far this month there have only been 8 ANDA approvals through November 23), seeing the number of Complete Response Letters, the number of ANDA receipts and other critical information that was included in the monthly activity report appears to be on hold until the IT folks can figure out how to generate those report under the new IT platform. Sounds like the platform may be a bit shaky.

Until the new reports begin, the window on transparency at OGD closes a bit more. Let’s hope this temporary glitch can be corrected quickly so the industry can have a peek into the productivity of OGD.