On December 2,2021 the U.S. (FDA) published the Fiscal Year (FY) 2022 Generic Drug User Fee Amendments (GDUFA) Science and Research Priority Initiatives. FDA determined these priority initiatives in collaboration with industry and the public, and solicited additional feedback on the scientific priorities in the annual Generic Drug Science and Research Initiatives Public Workshop, held in June 2021.
FDA committed to publishing these priority initiatives, which we believe help to further the mission of the generic drug science and research program. This program is important to the development of product-specific guidances and guidances for industry that can aid generic product development. The agency will continue to track and report on these priority initiatives.
FDA provides various collaboration opportunities to align with the GDUFA Science and Research Priority Initiatives and to improve scientific approaches for evaluating generic drugs.
These opportunities include collaborations for potential research contracts and grants in support of the FY 2022 GDUFA Science and Research Priority Initiatives.