GDUFA Research Outcomes
Other Generics Research
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to other research relevant to generic products.
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Regulatory Considerations on Dose-Scale Analysis in Assessing Pharmacodynamic Equivalence
Gong, Xiajing
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FDA Initiatives to Stimulate Innovation and Improve Patient Access to Generic Topical & Transdermal Products Part II
Ghosh, Priyanka
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Biopharmaceutics and Bioequivalence a Day in the Life
Wu, Fang
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Complex Drug Products and Potential Challenges to Generic Drug Development
Zhang, Lei
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Opening Remarks
Zhang, Lei
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ICH Reflection Paper: Further Opportunities for Harmonization of Standards for Generic Drugs
Zhang, Lei
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Role of Regulatory Science in Generic Drug Development and Application Assessment
Zhang, Lei; Lee, Sau
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GDUFA II: Pre-ANDA Program and Meetings for Complex Generic Products
Zhao, Liang
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Applications and Advance in Using Modeling and Simulation (M&S) to Support Drug Product Life Cycle Management
Zhao, Liang
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Overview of GDUFA II-funded Modeling and Simulation Grants/Contracts
Zhao, Liang