The Generic Drug User Fee Amendments (GDUFA) help the FDA fulfill its mission of protecting the public health and accelerating innovation in the industry. Specifically, it aims to promote access to safe, effective and high-quality generic products.
GDUFA enables FDA to assess industry user fees to bring greater predictability and timeliness to the review of generic drug applications. More specifically, the program holds all foreign and domestic companies to consistently high-quality standards, speeds the availability of low-cost, high-quality generic drugs through more predictable review processes for Abbreviated New Drug Applications (ANDAs) and increases transparency between manufacturers and the FDA by requiring the identification and registration of all facilities involved in the manufacturing of generics and their active ingredients.
Similarly, the Biosimilar User Fee Amendments (BsUFA) establish the framework for using the best processes and science available to approve new safe, effective and more affordable biosimilar medicines.
AAM and its members share and fully support GDUFA and BsUFA objectives and will continue to work with the FDA and the generic and biosimilar industries to provide timely access to safe, effective, high-quality affordable generic and biosimilar medicines.
- FDA: Generic Drug User Fee Amendments
- FDA Approvals: Good News for Patients, More Work to Do (Blog)
- Division of User Fee Management and Budget Formulation: GDUFA | BsUFA User Fees Updates