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.

• All(24)
• Posters(5)
• Presentations(16)
• Papers(3)

• Leveraging Modeling and Simulation to Make Regulatory Impacts for Long-Acting Generic Drug Approvals

  Zhao, Liang

• From Bench to Approval: the Role of GDUFA Research in Promoting Complex Generics

  Wang, Yan

• Bioequivalence of Polymeric Long Acting Drugs

  Wang, Yan

• Considerations and Expectations for in Vitro Release Testing of Complex Formulations

  Wang, Yan

• Development of Generic Long Acting Injectables: Regulatory Challenges and Considerations

  Wang, Yan

• Long Acting Injectable and Implantable Drug Product Development Regulatory Challenges and Considerations_GSK-CRS Conference

  Wang, Yan

• Characterization of Complex Excipients and Formulations

  Wang, Yan

• Challenges Associated with Development of Generic PLGAPLA Based Drug Products

  Wang, Yan

• Liposomes: Physicochemical Characterization and In Vitro Drug Release Testing

  Manna, Soumyarwit

• Navigating Formulation Assessments: General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness

  Kozak, Darby