FDA仿制药办公室发布4月统计数据
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FDA仿制药办公室发布4月统计数据
笔记 2014-06-03 Lachman CONSULTANTS 通常我专注于以ANDA的接收和批准数量作为仿制药办公室进度的衡量标准。但是这个月仅提一下2014年4月有41份完全批准和7份暂时批准,另外如下表所示,OGD收到74份ANDA。顺便提一下,OGD宣布在2014年4月发布了100份完全回复函。
我希望更仔细的看看这个月收到的增补并向大家指出有关增补的有趣事实。增补或对完全回复函(CRL)的回复表示申请人根据公司认为有必要对ANDA做出变更或需要回复一封CRL而更新ANDA的持续过程。令人感兴趣的是,大多数与增补相关的活动仍集中在2012年10月1日之前的积压ANDA。4月,OGD收到的155份增补中有122份是此类增补。正如你看到的,第1年队列和第2年队列的增补比起积压ANDA的增补来就相形见绌了。这显然反应了对于第1年和第2年队列ANDA采取行动和审评的长等待期。大多数第2年队列增补被假定为某类无谓增补,因为第2年队列ANDA的实际审评很可能刚刚开始,可能并没有发出多少第2年队列的完全回复函。我们无法根据提供的数字知道增补是因CRL而产生,还是仅仅是无谓增补,因此想要真正指出这些行动的性质有些困难。 不用说,如果有更详细的数据公布,或者如果提供ANDA和增补的实际积压数据,将更容易衡量OGD的进度。然而,从表面看,OGD大概除了当年队列的加速ANDA外仅完成了第1年队列申请的CRL。与设定的在仅仅4个月的时间里清还第3年队列ANDA的目标相比,还要有所付出。 另外一个有趣的现象与完全回复函后的会议请求有关。看起来申请人并没有真正利用这个机会澄清CRL中的缺陷或问题,因为,到2014财年的前7个月为止,仅有20个这样的会议请求。这与2013财年总共仅有23个对于CRL后的会议请求相近。不知是OGD的完全回复函写得越来越清楚了,还是企业自身没有利用这个重要的机会对感到困惑的问题的获得来自FDA的澄清。
当回顾下个月的统计数据时,我会尽量把注意力集中在OGD的统计报告中,以努力让您掌握我看到的最新问题,这些重要问题与理解OGD如何工作以及企业在未来一年将如何行动有关。 Lachman CONSULTANTS - Bob Pollock先生 2014-06-02 April OGD Statistics Just Published – Let's Look at the Numbers a Bit Differently Usually I concentrate on ANDAs received and the numbers approved as a measure of the Office of Generic Drugs' (OGD) progress, but this month, let's just mention that there were 41 full approvals and 7 tentative Approvals and, as the table below reveals, OGD received 74 ANDAs in April 2014. By the way, OGD reported issuing 100 Complete Response Letters in April 2014.
I would like to look more closely at the Amendments received this month and point out some interesting facts regarding them. Amendments or responses to Complete Response letters (CRL) represent the ongoing process of updating ANDAs by applicants based on either changes the firm deems necessary to make to the ANDA or in response to a CRL. Of interest is that most of the activity associated with amendments still focuses on the backlog of ANDAs that were before the Agency prior to October 1, 2012. In April, there were 122 such amendments out of a total of 155 received by OGD for the month. As you can see, amendments to Cohort Year 1 and Cohort Year 2 are dwarfed by the number of Backlog ANDA amendments. This obviously reflects the long lead time for Cohort Years 1 and 2 ANDA to be picked up and reviewed. Most of the Cohort Year 2 amendments are presumed to be gratuitous amendments of some sort, as the actual review of Cohort Year 2 ANDA is likely just beginning, thus not many Cohort Year 2 CRL have likely been issued. We cannot tell by the numbers provided if the amendments are in response to CRL or are just gratuitous amendments, so it is a bit hard to really put our finger on the nature of the activity. Needless to say, if there was a bit more granularity in the numbers reported, and if the actual backlog figures were presented for ANDA and Supplements, it might be easier to gauge OGD’s progress. However, from the look of things, OGD is just really getting to CRLs for Cohort Year 1 applications with possibly the exception of expedited ANDA in that Cohort year. With metrics set to kick in for Cohort Year 3 ANDAs in a mere 4 months, something has got to give! One other interesting observation is in relation to the Post-CRL Meeting requests. It appears that applicants are really not availing themselves of the opportunity to clarify deficiencies or issues in the CRL as there have only been a total 20 such requests so far in the first 7 months of FY year 2014. This tracks somewhat closely with a total of only 23 such request for post-CRL meeting in all of FY 2013. Either OGD is getting better at writing clear CRL or industry is just not availing themselves of this important opportunity to obtain clarification from FDA on issues they find confusing.
When I review the statistics for next month, I will try to concentrate on another aspect of the OGD statistical reports in an effort to keep you up to date with issues that I see as important relative to understanding how OGD is doing and how the industry will fare in the coming year. 识林www.shilinx.com,版权所有,如需转载请注明出处 |