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)

• Mechanistic Drug Delivery Models

  Zhao, Liang

• Future Challenges: Electronic Devices, Drug Use Related Software, and Impacts on Generic Development and Substitution

  Ballard, Betsy

• The Impact of Actuator Device Design on Metered Dose Inhaler (MDI) In Vitro Performance

  Bielski, Elizabeth

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

  Chang, Richard

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

  Conti, Denise

• 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

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

  Witzmann, Kimberly

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

  Witzmann, Kimberly

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

  Hartka, Kathryn