Remote work by the generic drug program staff did not seem to negatively impact the approval actions for ANDAs in March. The entire generic drug program staff was likely feeling the same (or even higher) anxiety that we are all feeling, with the stay at home orders in place. Speaking from experience, the coordination for getting the approval packages for applications is not easy when the staff is all together in one location and it is easy to walk down the hall to ask a question or get a signoff. And with all of that being done mostly remotely, OGD managed to issue 58 full approval actions and 13 tentative approval actions for a total of 71 approval actions, which represents the third highest total of FY 2020 thus far. Of course, these numbers are unofficial and may change when OGD issues its official count sometime later this month.
While the numbers may not be where industry wants them to be, kudos have got to go to OGD and OPQ and the other contributors to the generic drug review and approval process in these hard times. We will update you further once the February stats are complete and when the March approval and receipt numbers are officially posted on the Generic Drugs Program Activities Report – Monthly Performance Fiscal Year 2020, which can be found here.