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.
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Opeing Remarks
Zhang, Lei
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Generic Drug Development For Respiratory Products, US Food And Drug Administration Update
Newman, Bryan
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Comparative Analyses: Device and User Interface Considerations
Witzmann, Kimberly
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Generic Drug Development for Respiratory Products: US Food and Drug Administration Update
Witzmann, Kimberly
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Critical Importance of Excipients in Generic Product Development- Now and in the Future
Witzmann, Kimberly
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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
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Generic Drug Development For Respiratory Products, US Food And Drug Administration Update
Witzmann, Kimberly
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The Role of Comparative Analyses for Evaluation of Generic Drug-Device Combinations in an ANDA
Witzmann, Kimberly
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Overcoming Barriers to Entry for Complex Generic Oral Inhalation Drug Products
Witzmann, Kimberly
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Predictive Dissolution Methods fro OINDPs
Witzmann, Kimberly