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.

• All(113)
• Posters(9)
• Presentations(91)
• Papers(13)

• Challenges for Industry in Implementing New Computational Methods that Arise from Regulatory Science Initiatives

  Liang, Zhao

• GDUFA II: Pre-ANDA Program and Meetings for Complex Generic Products

  Le, Christine

• Opportunities Provided by the ICH Reflection Paper for Generics

  Lionberger, Robert

• Product-Specific Guidances for Complex Generic Drugs

  Luke, Markham

• Generic Ophthalmic Drug Products, Physical Characteristics, and Bioequivalence

  Kozak, Darby

• Navigating Q1/Q2 for Complex Generics

  Jiang, Xiaohui

• Challenges and Opportunities for Innovation in Complex Generic Drug Product Development

  Jiang, Xiaohui

• Challenges and Opportunities for Innovation in Complex Generic Drug Product Development

  Jiang, Xiaohui

• Complex Injectable and Implantable Drug Products: Bioequivallence Considerations

  Jiang, Wenlei

• “Genericize” the Complex Drug Product Landscape

  Jiang, Wenlei