Lachman CONSULTANTS - Bob Pollock先生 2014-12-15
编译：识林-椒 2014-12-19
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Look in Those Stockings – Is it Coal or a New Approval?
Written by Bob Pollock • December 15, 2014
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!
