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出自识林

2014-12-03 Lachman CONSULTANTS

今天检查过FDA官网关于仿制药批准的更新后，我失望的看到FDA仿制药办公室（OGD）在11月份仅批准了11件ANDA。在此之前，批准数量最低的月份是2014年7月，仅批准18件ANDA。继10月OGD令人鼓舞的批准了45件ANDA之后，11月的批准又跌入谷底。

如果我们回忆一下仿制药丑闻的日子，批准量从每月50-60件下降到每月10件或更少，直到1991财年底事情才开始改善（如下图所示）。

眼下，批准数据是与OGD效率相关的唯一信息，而公开可获得的仿制药月度行动报告看来已经成为新的CDER IT平台的受害者（相关资讯请见这里）。批准数据显然不能代表OGD所做的全部工作，例如（除其它工作外）对受控函的回复、完全回应函、行业会议、政策和规程的制定，但在仿制药企业衡量OGD成功工作标准的列表上，批准数据肯定位居榜首。

根据行动报告显示，11月最后的一件批准发生在2014年11月24日。感恩节周末假期照例影响了11月底的工作，而且众所周知12月底（圣诞节假期）同样也令OGD批准相对缓慢，但通常不会影响企业竞相在年底之前将申请递交到OGD。但是，今年在CDER的IT人员弄清楚如何生成可公开传阅的必要报告之前，我们可能甚至不会知道这些提交的数据。不幸的是，这是仿制药计划的另一个挫败，我们不知道新的IT平台问题实际上会如何影响OGD在GDUFA下跟踪所需数据的效率或能力。

Lachman CONSULTANTS - Bob Pollock先生 2014-12-02
编译：识林-椒 2014-12-03
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November 2014 Generic Approvals at Lowest Point since GDUFA Implementation
Written by Bob Pollock • December 02, 2014

After checking the generic drug approvals on FDA’s website today, I was disappointed to see that OGD only approved 11 ANDAs in the month of November. Prior to this, the lowest month was July 2014 when OGD approved only 18 ANDAs. This comes after October’s encouraging numbers, with OGD issuing 45 ANDA approvals.

If we take a walk down memory lane, back to the days of the generic drug scandal, approvals fell from 50-60 per month to a mere trickle of about 10 or less a month, until things started improving towards the end of FY 1991 (as depicted by the chart below).

Right now, approval data is the only information relative to OGD productivity that is publically available as the Generic Drug Monthly Activity Report apparently fell victim to the new CDER IT platform (see previous story here). The approval figures are obviously not representative of the total body of work that OGD produces as that includes (among other things) responses to controlled correspondence, Complete Response Letters, industry meetings, policy and procedure development, but it is certainly at the top of the list as the number one output product by which the generic industry gauges OGD success.

According to the Activity Report, the last approval for the month of November was issued on November 24, 2014. The holiday and vacation over the Thanksgiving weekend routinely impacts the end of November, and we know that the end of December is also relatively slow for OGD approvals, but usually not so for submissions as firms race to the end of the year to get their applications into OGD. But, this year, we may not even know what those submissions numbers look like until the IT folks in CDER can figure out how to generate the necessary reports that can be publically disseminated. Unfortunately, this is another setback for the Generics program and we don’t even know how the new IT platform problem actually impacts OGD productivity or ability to track required data under GDUFA.