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(25)
• Posters(1)
• Presentations(24)
• Papers(0)

• Closing Remarks

  Lionberger, Robert

• Drug Device Combination Products and Similarity

  Luke, Markham

• Drug-Device Combination Products Breakout Session

  Luke, Markham

• Complex Drug Product Landscape

  Jiang, Wenlei

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

  Walenga, Ross

• Drug-Device Combination Products

  Feibus, Karen

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

  Witzmann, Kimberly

• Considerations for Pre-ANDA Meeting Requests and Case Scenario Setup: Device Constituent of Hypothetical BREATHEATOL Drug Product

  Conti, Denise

• Introduction to Session 4: Device Considerations for Complex Drug-Device Combination Products

  Conti, Denise

• Overview of Complex Generic Inhalation, Nasal and Auto-Injector Drug-Device Combination Products

  Conti, Denise