OGD 12月批准行动仍不容乐观
出自识林
OGD 12月批准行动仍不容乐观
笔记 2014-12-19 Lachman CONSULTANTS 几天前,Cook发出一封关于新的人事变动以及OGD将如何推动申请批准愿景的备忘录。计划看起来不错，我相信我们将在未来一年（GDUFA第3年还剩9.5个月）看到进步。但到12月15日为止，我们仅看到本月有一件批准。 我知道这听起来有些善变，先写OGD正在改进，又写似乎缺乏产出，因为我们都知道这需要一些时间。我的本意并非如此，但是读者此时只有非常有限的渠道了解OGD的效率数据。或许这个假期会用年底一连串的批准带给我们惊喜；然而，每年的这个时候，随着许多OGD和OPQ人员的休假，在仿制药领域时间因欢乐假期而逐渐减少。 我们都听过“耐心是一种美德”和“我的神经非常脆弱”，这两句话加在一起差不多总结了仿制药企业的担忧程度。2014年即将结束，让我们期待2015年批准能够纷至沓来。 Lachman CONSULTANTS - Bob Pollock先生 2014-12-15 Look in Those Stockings – Is it Coal or a New Approval? Just a few days ago, I posted a memo from Cook (Acting Director, Office of Generic Drugs [OGD]) about the new personnel changes there and the vision of how OGD will drive applications to approval. The plan sounds good and I believe we will see movement in the coming year (remaining 9.5 months of GDUFA year three). But today is December 15th and, thus far, we have seen only one approval in December. I know that sounds a little fickle to write about OGD improvements in process and then write about the apparent lack of what is coming out of the pipe, because we all know that it will take some time. I don't mean to be that guy, but the readers have very limited access to the productivity numbers from OGD at this point in time. Maybe the holiday season will surprise us with a rush of approvals towards the very end of the year; however, at this time of year, and with a lot of OGD and Office of Product Quality (OPQ) staff taking holiday vacation, time is dwindling for a Happy Holiday in the generic drug arena. We have all heard the phrases “patience is a virtue” and “my nerves are wearing thin,” but these two phrases together pretty much sum up where the generic industry is on the worry scale. So, let's sit tight as 2014 comes to a close and keep our socks on to warm our toes and dream of 2015 where the approvals flow like a stream. Sorry, but I had to do it! Happy holidays to all and to all a good night – well, I may be back before December 19th, but our offices are closed from December 20-January 2, 2015 - if I don't get to write to you before then, have a happy, healthy and safe New Year! |