Generic Drug Activities Report Updated for August 2016

FDA has just updated the Activities Report of the Generic Drug Program with additional data from August 2016.  FDA notes that it Refused-to-File 17 ANDAs in August, which is slightly below the average of 21/month so far this Fiscal Year (FY). OGD issued 167 Complete Response Letters (CRL) in August, above the monthly average of 139 this FY.  FDA has issued a total of 1532 CRLs in the 11 months ending on August 31 with the largest numbers coming in the latter half of the year, which appear to indicate an increased output.

DMF reviews continue to fall and were at the lowest for FY 2016 at only 38 thus far in FY 2016.  This is to be expected, as many DMFs are pre-reviewed and multiple applicants can cite a single DMF.  CBE Supplements were at 519 vs. a monthly average of 453, but Prior Approval Supplements hit an FY 2016 high of 71 for the month of August vs. a monthly average of 40.

August controlled correspondence submissions were at 154 with an 11-month average of 156 in FY 2016.  The one thing I am surprised about is the number of post-CRL requests for teleconferences, which average just 3 a month.  I hear lots of complaints about CRLs being unreasonable or unclear, yet there have only been a total of 34 post-CR meeting requests in the first 11 months of FY 2016.  Go figure!