Through the last posting on the daily approval list on September 16, OGD has reported only 16 full approval actions and one tentative approval action.  If this rate keeps up through the rest of the month, we are likely to see the fewest number of monthly approval actions since the beginning of the GDUFA program.

This might be a bit of an overreaction, as there were no approval actions reported on the daily approvals page (here) (at least not by 10:30AM ET today) for September 14, 15, or 16.  This is an unusual scenario to see three (3) consecutive days with no approvals, so I am hoping that there has been a delay of some sort in the postings.  If not, this could raise more than a few eyebrows from industry, especially since the GDUFA III negotiations have just closed.

We will continue to monitor these numbers and let you know how things are going towards the end of this month (which will close out FY 2021).