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)

• Potential Types of Model Master Files

  Zhao, Liang

• Leveraging Model-Integrated Evidence for Generic Drug Development and Approval

  Zhao, Liang

• FDA Product-Specific Guidance Program Overview

  Bengston, Karen

• Quantitative Methods and Modeling in Regulatory Science

  Zhao, Liang

• Model Integrated Evidence as Pivotal Information for Drug Regulatory Decision Making: When, Where, and Why From Generic Drug Perspective

  Zhao, Liang

• Pioneering Modeling Methodologies in Generic Drug Development

  Zhao, Liang

• Application of Quantitative Methods and Modeling to Generic Drug Development

  Zhao, Liang

• GDUFA III Teleconferences and Meetings

  Zhang, Lei

• Bridging the Difference: Case Studies that Demonstrate Bioequivalence Assessments for Approved Suitability Petitions

  Boyce, Heather

• Newly Approved Complex Drug Products and Potential Challenges to Generic Drug Development

  Zhang, Lei