GDUFA Research Outcomes

Drug-Device Combo Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to considerations impacting the device constituent of generic drug-device combination products.

• All(38)
• Posters(2)
• Presentations(36)
• Papers(0)

• Mechanistic Drug Delivery Models

  Zhao, Liang

• Mechanistic Drug Delivery Models

  Zhao, Liang

• Mechanistic Drug Delivery Models

  Zhao, Liang

• Mechanistic Drug Delivery Models

  Zhao, Liang

• GDUFA Regulatory Science and Research on Generic Drug-Device Combination Products

  Witzmann, Kimberly

• Comparative Analyses: Device and User Interface Considerations

  Witzmann, Kimberly

• Overview of Regulatory and User-Interface Considerations, and the Role of Comparative Analyses, in Developing a Generic Drug-Device Combination Product in an ANDA

  Witzmann, Kimberly

• Overcoming Barriers to Entry for Complex Generic Oral Inhalation Drug Products

  Witzmann, Kimberly

• The Role of Comparative Analyses for Evaluation of Generic Drug-Device Combinations in an ANDA

  Witzmann, Kimberly

• Computational Fluid Dynamics (CFD) Modeling for Optimization of Device Design and Understanding of Product Performance

  Walenga, Ross