Generic Drug Research Priorities & Projects

Each year, FDA consults with industry and the public to develop a list of regulatory science initiatives on generic drugs in accordance with the Generic Drug User Fee Amendments (GDUFA). These priorities are discussed and developed in public meetings and workshops and result in several awarded projects each year. Research Priorities FY 2026 GDUFA Science and Research Priorities (PDF - 139 KB) FY 2025 GDUFA Science and Research Priorities (PDF - 145 KB) FY 2024 GDUFA Science and Research Priorities (PDF - 126 KB) FY 2023 GDUFA Science and Research Priorities (PDF - 153 KB) FY 2022 GDUFA Science and Research Priorities (PDF – 143 KB) FY 2021 GDUFA Science and Research Priorities (PDF – 123 KB) FY 2020 GDUFA Science and Research Priorities (PDF – 107 KB) FY 2019 GDUFA Science and Research Priorities (PDF – 113 KB) FY 2018 GDUFA Science and Research Priorities (PDF – 113 KB) FY 2017 GDUFA Science and Research Priorities (PDF – 113 KB) FY 2016 GDUFA Science and Research Priorities (PDF – 116 KB) FY 2015 GDUFA Science and Research Priorities (PDF – 113 KB) FY 2014 GDUFA Science and Research Priorities (PDF – 113 KB) FY 2013 GDUFA Science and Research Priorities (PDF – 113 KB) GDUFA Regulatory Science Initiatives Public Workshops & Meetings FY2025 Generic Drug Regulatory Science Initiatives Public Workshop (June 3-4, 2025) FY2024 Generic Drug Regulatory Science Initiatives Public Workshop (May 20-21, 2024) FY2023 Generic Drug Regulatory Science Initiatives Public Workshop (May 11-12, 2023) FY2022 Generic Drug Regulatory Science Initiatives Public Workshop (May 9-10, 2022) FY2021 Generic Drug Regulatory Science Initiatives Public Workshop (June 23, 2021)​ FY 2020 Generic Drug Regulatory Science Initiatives Public Workshop (May 4, 2020) FY 2019 Generic Drug Regulatory Science Initiatives Public Workshop (May 1, 2019) FY 18 Generic Drug Research Public Workshop (May 24, 2018) FY 2017 Generic Drug Research Public Workshop (May 3, 2017) FY 2016 Regulatory Science Initiatives Part 15 Public Meeting (May 20, 2016) FY 2015 Regulatory Science Initiatives Part 15 Public Meeting (June 5, 2015) FY 2014 Regulatory Science Initiatives Part 15 Public Meeting (May 16, 2014) FY 2013 Regulatory Science Initiatives Part 15 Public Meeting (June 21, 2013) Awarded Projects FY 2024 Awarded GDUFA Science and Research Contracts and Grants (PDF - 162 KB) FY 2023 Awarded GDUFA Science and Research Contracts and Grants (PDF - 173 KB) FY 2022 Awarded GDUFA Science and Research Contracts and Grants (PDF - 160 KB) FY 2021 Awarded GDUFA Science and Research Contracts and Grants (PDF – 197 KB) FY 2020 Awarded GDUFA Science and Research Contracts and Grants (PDF – 182 KB) FY 2019 Awarded GDUFA Science and Research Contracts and Grants (PDF – 182 KB) FY 2018 Awarded GDUFA Science and Research Contracts and Grants (PDF – 196 KB) FY 2017 Awarded GDUFA Science and Research Contracts (PDF – 98 KB) FY 2016 Awarded GDUFA Science and Research Contracts and Grants (PDF – 98 KB) FY 2015 Awarded GDUFA Science and Research Contracts and Grants (PDF – 143 KB) FY 2014 Awarded GDUFA Science and Research Contracts and Grants (PDF – 98 KB) FY 2013 Awarded GDUFA Science and Research Contracts and Grants (PDF – 98 KB) GDUFA Implementation Bi-Annual Industry Regulatory Science Working Group Meeting - November 17, 2025 Bi-Annual Industry Regulatory Science Working Group Meeting - August 6, 2025 Bi-Annual Industry Regulatory Science Working Group Meeting - October 30, 2024 Bi-Annual Industry Regulatory Science Working Group Meeting - August 28, 2024 Bi-Annual Industry Regulatory Science Working Group Meeting - November 17, 2023 Bi-Annual Industry Regulatory Science Working Group Meeting - August 30, 2023 Bi-Annual Industry Regulatory Science Working Group Meeting - December 8, 2022 Bi-Annual Industry Regulatory Science Working Group Meeting - March 23, 2022 Bi-Annual Industry Regulatory Science Working Group Meeting - September 24, 2021 Bi-Annual Industry Regulatory Science Working Group Meeting - March 12, 2021 Bi-Annual Industry Regulatory Science Working Group Meeting - February 10, 2020 Bi-Annual Industry Regulatory Science Working Group Meeting - September 17, 2019 Bi-Annual Industry Regulatory Science Working Group Meeting - February 25, 2019 Bi-Annual Industry Regulatory Science Working Group Meeting - November 1, 2018 Bi-Annual Industry Regulatory Science Working Group Meeting - April 10, 2018