Dr. Kathleen (Cook) Uhl said there would be good months and not-so-good months. Well, although the official numbers for November are not yet posted, it looks like OGD will have another good month. Not a record breaker, but close, unless there are at least 4 more not yet reported approval actions lurking somewhere in the IT reporting system. According to the FDA All Approval list (here), there appear to be 124 total approval actions in November (96 full approval and 28 tentative approval). That number fall just 4 short of the October record of 128 approval actions (110 full approval and 18 tentative approval [TAs]).
The positive trend that we have seen recently thus appears to continue. And with the number of TAs increasing, it appears that OGD is also now teeing up more ANDAs to be ready for final approval at the first available date of full approval. Good work OGD, OPQ Office of Compliance, General Counsel, and all the other Offices that have to touch the ANDAs along the way.
Cook will leave behind a true legacy at her retirement in February, as she has certainly led the program to great success. While there is still work to be done, in my opinion, the core is now solidified. Could GDUFA II keep things moving in the right direction? We have just under 4 more years to fully answer that question.