FDA published the FY 2027 GDUFA Fee Rates today (here) and it is mostly good news for the industry. While ANDA fees went up by $17,437 and DMFs popped up another $7,315, all facility fees dropped. This is likely because of a lower number of ANDAs that have been submitted over the past year (580) (we predicted about 624 ANDAs to be submitted in FY 2026) with the Agency’s ANDA total projected to be only a slight increase of ANDA submissions to 586 for FY 2027. Manufacturing facilities fees all decreased, which indicates an increase in the number of manufacturing facilities.
Program fees increased only slightly, which is also good news for ANDA applicants.
Based on FDA investigation and facility listing data, the FDA estimated that the FDF and CMO facility denominators are 156 FDF domestic, 332 FDF foreign, 92 CMO domestic, and 155 CMO foreign facilities for FY 2027. In addition, the estimate for the total number of API facilities identified was 753; of that number, 81 were domestic and 672 were foreign facilities. I think you can see how this plays into the Administration’s push for onshoring both FDF and API manufacturing.
The new fees go into effect on October 1, 2026, which is the start of FY 2027. So, while you need to get out those checkbooks, it might not be as painful to write the check for next year’s fees as it has been in previous years!
