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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Incentivizing Generic Drug Competition
Luke, Markham
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What’s Important to Consider When Developing a Complex Drug
Lionberger,Robert
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Bioequivalence and Complex Generics: How to Get Pre-submission Advice
Lionberger,Robert
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GDUFA II Pre-ANDA Program Meetings for Complex Products
Lionberger,Robert
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Using Quantitative Methods and Modeling to Transform Generic Drug Development and Review
Lionberger,Robert
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Complex Generics 2022 Update
Lionberger, Robert
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Overview of the FDA Product-Specific Guidance (PSG) Program
Le, Christine
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Critical Roles of Excipients in the Development of Generic Drug Products
Lionberger, Robert
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Suitability Petitions Enable Generics
Lionberger, Robert
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Complex Generics Town Hall
Lionberger, Robert