这是CDER传统上处理新药审评和批准活动方式的巨大变化，且很可能在新办公室落成之前扰乱CMC审评效率。FDA White Oak园区的办公空间严重短缺将使其很难让新同事了解彼此。我们希望这将不会进一步拖延仿制药批准，虽然我非常怀疑。令人不解的是，CDER将所有这些重大变化置于重要的新使用者付费计划GDUFA的中间时期实施。
Janet Woodcock Launches the Office of Product Quality
Written by Garth Boehm • October 17, 2014
“If you want a job done properly, do it yourself” as the saying goes. On October 16 Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) sent an email to all Center staff officially launching the new Office of Product Quality (OPQ) after a gestation period of just over 2 years! Apparently the new “Super Office” will begin working on January 1, 2015 (probably without any staff since this day is a public holiday). More unexpected is that Woodcock herself will be the Acting Director of the new Super Office! It is rumored that there is considerable opposition within CDER to this new arrangement, so like I said “if you want a job done properly …”. Laurence Yu will be the Deputy Director.
Details of the new office staffing are on the brand new OPQ web page.
There are 8 Offices in the new OPQ Super Office. This is a major change to the way CDER handles New Drug Approvals and Product Lifecycle activities. The following major (and very probably disruptive) function changes are occurring.
Many of the personnel currently in the Office of Pharmaceutical Science will move to OPQ.
Key among these staff for Generic Drugs are all the CMC review staff
The Office of Compliance will cede its Preapproval and Routine Surveillance activities to OPQ.
This means that the inspectors companies will see in future will come from OPQ
Bioequivalence/Bioavailability and non-clinical inspectional activities will move to the Office of Transitional Sciences
This is a huge change in the way that CDER traditionally handled New Drug Review and Approval activities and is likely to be disruptive to CMC review productivity until the new office settles down. This will not be helped by the critical shortage of office space at FDA's White Oaks Campus which will make it difficult for the new co-workers to get to know each other. We hope that this will not further delay Generic Drug Approvals, but I fear that it will. It is puzzling that CDER would make all these major changes literally in the middle of a major new User Fee program, GDUFA.
One last observation. Six of the eight Office leaders within the new OPQ are women perhaps indicating that women are less stubborn than men when it comes to adapting to major change – maybe that is true!!
