Well summertime and its usual vacation schedule has not put a damper on ANDA approval actions and thus, I am happy to report that posting through August 16th reveal that OGD has issued 41 full approval actions and 7 tentative approval actions.  If this pace keeps up for the rest of August, this will be another good month for OGD’s approval output.

With only a month and a half left in FY 2023, everyone is anxious to see how the first year of GDUFA III will turn out in terms of productivity both from FDA as well as industry.  With application and program fees going up considerably for FY 2024 (see here) I am expecting a big rush to get the end of FY ANDA submission into OGD before September 30! We will see how the industry reacts to the new fees and if they push for pre-October 1 submissions or just decide to pay the new freight. Time will tell!