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)

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

  Zhao, Liang

• Applications and Advance in Using Modeling and Simulation (M&S) to Support Drug Product Life Cycle Management

  Zhao, Liang

• Overview of GDUFA II-funded Modeling and Simulation Grants/Contracts

  Zhao, Liang

• Risk Assessment and Management for Formulation Change Using Model Integrated Approach

  Zhao, Liang

• Impact of Modeling and Simulation on Drug Product Life Cycle Management

  Zhao, Liang

• Computational Pharmaceutics: Scientific Gaps and Forthcoming Research to Modernize Regulatory Science

  Zhao, Liang

• Pre-ANDA Program

  Arora, Sumit

• The GDUFA II Pre-ANDA Program for Complex Products

  Andre, Kris

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

  Andre, Kris

• Practical Tips on Using the CDER NextGen Collaboration Portal

  Andre, Kris