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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Product-Specific Guidances for Complex Generic Drugs
Luke, Markham
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Generic Ophthalmic Drug Products, Physical Characteristics, and Bioequivalence
Kozak, Darby
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Navigating Q1/Q2 for Complex Generics
Jiang, Xiaohui
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Challenges and Opportunities for Innovation in Complex Generic Drug Product Development
Jiang, Xiaohui
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Challenges and Opportunities for Innovation in Complex Generic Drug Product Development
Jiang, Xiaohui
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Complex Injectable and Implantable Drug Products: Bioequivallence Considerations
Jiang, Wenlei
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“Genericize” the Complex Drug Product Landscape
Jiang, Wenlei
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Generic Drug Science & Research Priorities for Fiscal Year (FY) 2023
Raney, Sameersingh
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GDUFA II: Pre-ANDA Program and Meetings for Complex Generic Products
Sarago, Caliope
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Approach to a Comparative Analysis When the RLD is Unavailable
Soukup, Stephanie