GDUFA Research Outcomes

Human Factors

Research in this area is related to human factors and interactions with the user interface of generic drug-device combination products.

• All(19)
• Posters(2)
• Presentations(15)
• Papers(2)

• 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

• 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

• Device Considerations from User Interface Perspective: Comparative Analyses

  Zhao, Liang

• Facilitating Drug Development Through GDUFA Regulatory Science and Research Opportunities for Collaboration with FDA

  Chakma, Monbi S; Usmani, Omar; Meah, Sally; Biddiscombe, Martyn; Bielski, Elizabeth; Feibus, Katharine; Natarajan, Karthika; Li, Karen; Kinjo, Minori; Illoh, Onyekachukwu; Han, Liangfeng; Newman, Bryan; Murnane, Darragh

• Dry Powder Inhaler (DPI) Resistance: Human Behaviour and Psychology of Patient Inspiratory Effort

  Chakma, Monbi S; Meah, Sally; Biddiscombe, Martyn; Murnane, Darragh; Bielski, Elizabeth; Feibus, Katharine; Natarajan, Karthika; Li, Karen; Kinoj, Minori; Illoh, Onyekachukwu; Han, Liangfeng; Newman, Bryan; Usmani, Omar S