The first month of the new fiscal year (FY 2026) appears to have gotten off to a slightly slower start than anticipated with the OGD reporting 23 full approval actions and 12 tentative approval actions. While there were 23 full approval actions, one of these represented a second strength of a previously approved product so it will not count as a separate ANDA approval in the OGD’s monthly statistical report. There were also two reported tentative approvals that will be folded into one ANDA as it was for the same drug but submitted separately because they were for different strengths. So, the numbers reported thus far in October will actually represent 22 original approved applications and 11 tentatively approved applications when they are captured in the monthly statistical report.
The slightly slower start is likely due to the government shutdown and the resultant stress placed upon OGD and OPQ staff. We are now at day 20 of the shutdown and the GRx-Biosims meeting is next week. While it was recently announced by AAM that Commissioner Makary will be a presenter at this meeting, it is not known whether any other FDA personnel will be in attendance. The shutdown, as well as other government actions over the last few years, have impacted the GRx-Biosims meeting in the past. It will be unfortunate if the shutdown does not end this week and other FDAers cannot attend the meeting; it would be a missed opportunity for industry and FDA staff to interact face to face and to share knowledge and ideas.
