November 2016 OGD Stats Updated

OGD posted additional statistics relative to metrics that it routinely tracks by month.  Included in these numbers are data on Refuse-to-Receive (RTR) actions, supplements received, controlled correspondence, etc.

All of FY 2016 monthly RTR actions were in the double digits except for September, which saw only 9 RTR actions.  Well, 2017 seems to be starting in the right direction as the October and November RTR actions were reported at 9 and 8.  Hopefully, this is trend (last three-month average just under 9 RTRs), which can be interpreted to mean that the industry is providing more complete applications.  FY 2016 monthly average was at 20.5.

Prior approval supplements dropped to 27 in November, the lowest since November FY 2015 (22).  CBE supplements totaled 430 for November, down slightly from the 493 submitted in October 2016.

There were 50 DMF reviews completed in the month, about on track with what we have seen over the last few months. Controlled Correspondences (CC) submitted stood at 162 for the month, which is in line with what we have seen over the GDUFA years.  Clearly, there are still a significant number of questions that the industry needs answered to conduct its business.  It may be interesting to see if OGD will provide an update on the types or categories of CCs again this year to see where additional guidance development may be needed.  Remember though, while the Controlled Correspondence figures reported monthly by OGD represent only those meeting the definition of a CC in the MaPP, there are numerous other questions that flow into OGD daily through various web addresses.  I can’t recall seeing any statistics on those recently.

We anxiously await the December numbers, especially those on receipts and approvals to gauge the end-of-year activity from industry and OGD.