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)

• An FDA Perspective on Best Practices for Comparative Analyses: Challenges & Opportunities

  Feibus, Katherine; Fine, Andrew; Flint, Jason

• Drug-Device Combination Products

  Feibus, Karen

• 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

• Device Considerations for Pre-ANDA Meeting Requests for Complex Drug-Device Combination Products

  Conti, Denise

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

  Conti, Denise

• Emerging Technologies for Bioequivalence of Generic Complex Drug-Device Combination Products

  Conti, Denise

• Determining “Other Design Differences” and Ways to Support Generic Substitutability

  Conrad, Megan; Privitera, Mary Beth

• Pre-ANDA Opportunities for Generic Drug-Device Combination Product Development

  Clerman, Andrew

• Quality Considerations for Injectable Drug-Device Combination Products in Abbreviated New Drug Applications (ANDAs)

  Chang, Richard