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)

• Device and User Interface Assessment Recommendations in Drug-Device Combination Product PSGs

  Natarajan, Karthika

• Generic Drug-Device Combination Product Assessment

  Luke, Markham C; Berry, Karyn L; Ren, Ke

• Drug Device Combination Products and Similarity

  Luke, Markham

• Drug-Device Combination Products Breakout Session

  Luke, Markham

• Closing Remarks

  Lionberger, Robert

• Complex Drug Product Landscape

  Jiang, Wenlei

• Understand Best Practices of User Interface Assessment for Generic Drug-Device Combination Products

  Hartka, Kathryn

• Pre-ANDA Program Support of Generic Drug-Device Combination Products

  Hartka, Kathryn

• Comparing Device User Interfaces and Seeking Advice in the Pre-ANDA Period

  Hartka, Kathryn

• User Interface Design Taxonomy: A Systematic and Repeatable Method for Identifying and Classifying Design Differences in Combination Products

  Feibus, Katharine