October is the first month of the fiscal year 2023 and, while not necessarily a bellwether of things to come, it is certainly the starting point of GDUFA III. The unofficial tally looks good as OGD issued 58 full approval actions and 11 tentative approval action for a total of 69 total approval actions. While the 58 is 2 below last FY’s monthly average of 60 for full approval actions, it beat last October’s 49.
The magic occurs when the total of approval actions is over the mid-70s so we are very close out of the starting gate. We will update these numbers after OGD releases the official data for October which will probably be in about a week or two.
