FDA2015财年仿制药行动数据部分更新
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FDA2015财年仿制药行动数据部分更新
笔记 2015-10-16 Lachman CONSULTANTS 2015财年仿制药行动报告的部分更新最近已经公布,我们看到最近批准数量的激增,完全回应函(CRL)的签发数量看起来在整个前3年GDUFA队列年中变化不大。
* - 截至2015年8月 这张图表向我们展示了2015财年仿制药办公室(OGD)做出了什么样的进展呢?
解析数据很容易对趋势做出草率的观察,但我真的不认为我们拥有足够的数据点来作出任何合理的全面性概括。我有点惊讶于全年总的CRL数量,也许这个数字会更高,如果OGD没有试图推动ANDA获得批准而不是仅发布一封CRL。然而,我们必须记住,GDUFA招聘和培训已经持续三年。约600人直接在审评岗位,另外300多人在OGD和药品质量办公室(OPQ)之外仿制药审评支持岗位,这些资源还没有转化为显著增加的可见输出。我们肯定会给OGD和OPQ一些信心,采取措施改善交流、审评效率和流程透明度,以及解决GDUFA目标函之外的问题,但众所周知,事实胜于雄辩。我们将密切关注这些数字,相信他们将继续提高。 Lachman CONSULTANTS - Bob Pollock先生 2015-10-12 ANDA Approvals Are Ticking Up but CRLs Do Not Appear to be Rising Partial updates to the Generic Activity Report for FY 2015 were recently published and, while we see a recent surge of approvals, the number of Complete Response Letters (CRLs) issued appears to be flat across all of the first three GDUFA Cohort years.
*- thru August 2015 What does this chart tell us about FY 2015 and the progress the Office of Generic Drugs (OGD) has made?
Parsing the numbers, it is easy to make casual observations about trends, but I don't really think that we have enough data points yet to make any reasonable overall generalizations. I am a bit surprised at the CRL total for the year; maybe they would be higher if OGD was not trying to drive ANDAs to approval instead of just issuing a CRL. However, we must remember that hiring and training under GDUFA was really over a three-year span. Thus, some 600 direct review positions and another 300 + generic drug review support positions outside of OGD and Office of Product Quality (OPQ) has not yet translated into significantly increased visible output. We will definitely give OGD and OPQ credit for taking steps to improve communication, review efficiency, and processes transparency and address issues outside of the GDUFA Goals Letter, but, as we all know, numbers speak louder than words. We will keep an eye on these numbers and we do believe they will continue to improve. |