GDUFA Research Outcomes
Vaginal Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the vaginal route, including vaginal gels and creams.
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Leveraging Modeling and Simulation to Make Regulatory Impacts for Long-Acting Generic Drug Approvals
Zhao, Liang
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From Bench to Approval: the Role of GDUFA Research in Promoting Complex Generics
Wang, Yan
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Considerations and Expectations for in Vitro Release Testing of Complex Formulations
Wang, Yan
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Development of Generic Long Acting Injectables: Regulatory Challenges and Considerations
Wang, Yan
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Characterization of Complex Excipients and Formulations
Wang, Yan
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Long Acting Injectable and Implantable Drug Product Development Regulatory Challenges and Considerations_GSK-CRS Conference
Wang, Yan
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Challenges Associated with Development of Generic PLGAPLA Based Drug Products
Wang, Yan
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Liposomes: Physicochemical Characterization and In Vitro Drug Release Testing
Manna, Soumyarwit
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Navigating Formulation Assessments: General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness
Kozak, Darby
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Development of Model-Informed Bioequivalence Evaluation Strategies for Long-Acting Injectable Products (LAI)
Karlsson, Matt; Chen, Xiaomei; Hooker, Andrew