This is the first month of GDUFA III and thus the first month of FY 2023! For approval actions posting through October 19th which include approvals posting through October 17th (postings are usually one or two days behind the actions taken), OGD has issued 22 full approval actions and 6 tentative approval actions for a mid-month total of 28 approval actions.
Given the past few months’ history, this represents a rather slow start to October, especially with the past three months averaging just under 70 full approval actions/per month! A slow start to this month could signal OGD taking the time to implement many of the changes introduced under GDUFA III and perhaps some in-house training to kick off the new 5-year cycle of GDUFA. Or maybe we will see a dramatic increase in approvals when the month progresses, who knows. I know what we are hoping for and we will be here to bring you the latest unofficial approval numbers a few days after the month closes out.
