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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Workshop Introduction
Lionberger, Robert
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Harmonization of Bioequivalence FDA Perspective
Lionberger, Robert
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Keys to Success for Complex Generics
Lionberger, Robert
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FY 2019 GDUFA Regulatory Science Initiatives Public Workshop
Lionberger, Robert
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Closing Remarks – May 1, 2019 Generic Drug Research Public Workshop
Lionberger, Robert
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Innovative Approaches for Complex Generics
Lionberger, Robert
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Path to Bioequivalence for Complex Products: Past, Present and Future
Lionberger, Robert
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Challenges for Industry in Implementing New Computational Methods that Arise from Regulatory Science Initiatives
Liang, Zhao
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GDUFA II: Pre-ANDA Program and Meetings for Complex Generic Products
Le, Christine
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Opportunities Provided by the ICH Reflection Paper for Generics
Lionberger, Robert