Dec 10, 2021· Comment from Medical Imaging & Technology Alliance· FDA-2020-N-1459-0019
The Medical Imaging & Technology Alliance (MITA) appreciates the opportunity to comment on the Generic Drug User Fee Act. Promoting an efficient and appropriately funded review process is in the best interest of the public health and the generic drug industry which supports and promotes public health. In MITA's comments originally posted on August 20, 2020, we stated our support for 1) Reauthorization of GDUFA, 2) Continued exclusion of all user fees for PET drug manufacturers, and 3) Continued self-identification for PET drug manufacturers with a simplified electronic process.