GDUFA Research Outcomes
Inhalation Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the inhalation route, including orally inhaled products.
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FDA Perspective on Scientific and Regulatory Considerations for MDIs Transitioning to a Low Global Warming Potential Propellant
Newman, Bryan; Luke, Markham
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Day 2 Overview
Newman, Bryan
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Design Considerations for Alternative Bioequivalence Approaches for Generic Orally Inhaled Drug Products
Newman, Bryan
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Challenges & Considerations for the Transition to Low Global Warming Potential (LGWP) Propellants with Metered Dose Inhalers
Newman, Bryan
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Designing Alternatives to Comparative Clinical Endpoint and Pharmacodynamic Bioequivalence Studies – Does One Approach Fit All for Generic Orally Inhaled Drug Products?
Newman, Bryan
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Nasal Products: Current Landscape and Recent Advancements
Newman, Bryan
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Overview of Complex Generic Orally Inhaled Drug Products
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