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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Enhanced Analytical Tools for Bioequivalence Evaluation of Nasal Spray Drug Products
Rodriguez, Jason
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Development of Enhanced Analytical Tools for Evaluation of Complex Generic Products
Rodriguez, Jason
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Nasal Products: Current Landscape and Recent Advancements
Newman, Bryan
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Addressing the Challenges with Orally Inhaled and Nasal Drug Products (OINDPs) Through the Pre-ANDA Meeting Process
Newman, Bryan; Dhapare, Sneha; Walenga, Ross; Feng, Kairui
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Overview of Complex Generic Inhalation and Nasal Drug-Device Combination Products
Newman, Bryan
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PSG Recommendations and Updates for OINDPs
Newman, Bryan
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Bioequivalence Considerations for Conducting Bridging Studies with Orally Inhaled and Nasal Drug Products
Ma, Tian
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Generic Drug Development For Respiratory Products, US Food And Drug Administration Update
Luke, Markham; Witzmann, Kimberly; Conti, Denise
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Session 3: Realistic Models for Prediction of Regional Drug Deposition from Orally Inhaled and Nasal Drug Products (OINDPs)
Luke, Markham
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Generic Drug Development For Respiratory Products, US Food And Drug Administration Update
Luke, Markham; Witzmann, Kimberly; Conti, Denise