GDUFA Research Outcomes

Nasal Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the nasal route, including nasal sprays.

• All(136)
• Posters(22)
• Presentations(67)
• Papers(47)

• Comparative Analyses: Device and User Interface Considerations

  Witzmann, Kimberly

• Critical Importance of Excipients in Generic Product Development- Now and in the Future

  Witzmann, Kimberly

• Generic Drug Development for Respiratory Products: US Food and Drug Administration Update

  Witzmann, Kimberly

• Generic Drug Development For Respiratory Products, US Food And Drug Administration Update

  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

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

  Witzmann, Kimberly

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

  Witzmann, Kimberly

• Predictive Dissolution Methods fro OINDPs

  Witzmann, Kimberly

• Sensitivity of Charcoal Block PK Metrics to Differences in Regional Deposition for Budesonide and Formoterol Fumarate Dihydrate

  Walenga, Ross; Tsakalozou, Eleftheria; Chopski, Steven; Fang, Lanyan (Lucy); Liang, Zhao

• Complex Nasal Suspensions: Utilization of In Silico Studies to Support Development and Approval

  Walenga, Ross