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出自识林

2016-08-31 Lachman CONSULTANTS

虽然在更新数据方面没有太多新的数据或趋势，但很显然美国FDA仿制药办公室（OGD）正在发布更多完全回应函（CRL）。OGD 7月份发布169封CRL，成为2016财年次高的月份（4月份最高190封）。这些数字也比过去几年显著更高。

Activities Report of the Generic Drug Program (FY 2016)

这意味着两件事情，1）FDA正在加快审评和CRL发布速率，2）仿制药企业正在被信息请求（IR）和易更正缺陷（ECD）函所淹没，并且不能在限定时间框架内回复，即使时间延长到迫使FDA发布CRL。企业也可以内部优先处理对企业最重要产品的IR和ECD回复，而留下其它未决回复迫使FDA发布CRL。

今天公布的数字还显示了OGD 7月拒绝接收（RTR）14件ANDA，比到目前为止2016财年的月平均量22件有所下降。这令仿制药企业看起来有了希望，尽管在审评指示板上的数字经常有波动。7月份DMF完整性审查量为86，比2016财年月平均批准量80件略低。

7月变更待批（CBE）补充申请共357件，成为2016财年第二低的月份，到目前为止月平均量为447件。7月份提交的之前获批申请的补充申请共33件，比2016财年月平均提交量37.4件有所降低。

很显然，OGD仍有很多工作需要做，企业也是如此。平衡IR和ECD和回复CRL的需求是递交新的ANDA。距离对2016年10月1日及之后提交的原始ANDA的GDUFA目标上升至10个月内完成90%的审评仅剩一个月的时间了。OGD能实现更多的首轮批准以帮助审评过程变得更有效率吗？企业能够及时地回复IR和ECD吗？这些都有待观察。在这一点上，我们将继续关注我们所看到的数字和报告。我们也正等待FDA关于第三年队列提交的首轮批准量和百分比的更新。

Lachman CONSULTANTS - Bob Pollock先生
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Report on Activity of the Generic Drug Program Updated for July
By Bob Pollock | August 29, 2016 原文地址

While there is not much new or trendy in the updated figures, it is clear that OGD is issuing more Complete Response Letters (CRLs). July saw the second highest number of CRLs for FY 2016 with 169 (highest was 190 in April). These numbers are also significantly higher than those in previous years.

This means one of two things, 1) either FDA is stepping up their rate of reviews and CRLs, or 2) generic firms are being overwhelmed by Information Requests (IRs) and Easily Correctible Deficiencies (ECDs) letters and cannot respond within the proscribed time frame, even with an extension which forces FDA to issue a CRL. Firms may also internally be prioritizing IR and ECD responses for products with the most importance to the company, thus leaving others unanswered and also forcing the FDA to issue a CRL.

Figures released today also show that Office of Generic Drugs Refused to Receive (RTR) 14 ANDAs in July down from a monthly average of 22 for FY 2016 to date. That is promising, even though these numbers seem to jump around all over the board. DMF reviews were at 86 for July, a bit below the 2016 monthly average 80 for FY 2016.

Changes Being Effected Supplements hit their second lowest monthly total for FY 2016 at 357, as compared to a monthly average of 447. There were 33 Prior Approval Supplements submitted in July down a tad from the 2016 monthly average of 37.4.

It is clear that OGD still has a lot of work to do and industry does too. Balancing IRs and ECDs and responses to CRLs is the need to file new ANDAs. We are just over a month when the GDUFA goal for original ANDAs submitted on or after October 1, 2016 ramps up to 90% reviews completed within 10 months. Can OGD get more first-cycle approvals to help the process become more efficient? Can firms respond in a timelier manner to IRs and ECDs? That remains to be seen. In that regard, we will continue to watch the numbers and report what we see. We are also awaiting an update from FDA on the numbers and percentages of first-cycle approvals for cohort year 3 submissions. We will see what comes down the pike.