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In this section: Generic Drugs

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 2023 GDUFA Science and Research Priorities (PDF - 153KB)
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

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)

Scientific Workshops & Meetings

FDA and Center for Research on Complex Generics Co-Hosted Workshop: Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches (September 30 – October 1, 2021)
SBIA 2021 Workshop- Advancing Generic Drug Development: Translating Science to Approval – Virtual Workshop (September 21-22, 2021)
In Vitro Release Test (IVRT) and In Vitro Performance Test (IVPT) Methods: Best Practices, Regulatory Standards, and Scientific Considerations – Virtual CRCG Workshop (August 18-20, 2021)
Upcoming: Advancing Innovative Science in Generic Drug Development Workshop (September 29-30, 2020)
Complex Generic Drug Product Development Workshop (September 25-26, 2019)
New Insights for Product Development and Bioequivalence Assessments of Generic Orally Inhaled and Nasal Drug Products (January 9, 2018)
FDA-DIA Workshop on Complex Generic Drug-Device Combination Products (October 9-10, 2018)
Complex Generic Drug Product Development Workshop September 12-13, 2018
Overcoming Barriers to the Development of, and Improving Patient Access to, Topical Dermatological Generic Drug Products (October 20, 2017)
Demonstrating Equivalence of Generic Complex Drug Substances and Formulations: Advances in Characterization and In Vitro Testing (October 6, 2017)
Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review (October 2-3, 2017)
Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation Workshop (May 19, 2016)

Awarded Projects

FY 2022 Awarded GDUFA Science and Research Contracts and Grants (PDF - 160KB)
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 Group Meeting – March 23, 2022
Bi-Annual Industry Regulatory Science Group Meeting – September 24, 2021
Bi-Annual Industry Regulatory Science Group Meeting - March 12, 2021
Bi-Annual Industry Regulatory Science Group Meeting - February 10, 2020
Bi-Annual Industry Regulatory Science Work Group Meeting – September 17, 2019
Bi-Annual Industry Regulatory Science Work Group Meeting – February 25, 2019
Bi-Annual Industry Regulatory Science Work Group Meeting – November 1, 2018
Bi-Annual Industry Regulatory Science Work Group Meeting – April 10, 2018

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