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.
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Evaluating 3D-Printed Pre-separator Inserts in a Fast Screening Impactor for Physicochemical Characterization of Fine Particle Dose Release from Dry Powder Inhalers
Reed, Nathan; Dar, Roee; Holtgrewe, Nicholas; Cao, Leo N Y; Liu, Xiaofei; Conti, Denise S; Newman, Bryan; Bielski, Elizabeth; Rodriguez, Jason D; Guo, Changning
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Development of Drug-Device Combination Products and Generic Substitution in the United States: An Overview
Srivastava, Ila; Lee, YoonJung; Feibus, Katharine; Bielski, Elizabeth; Sterrett, Lolita; Harris, Danielle; Luke, Markham
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Seeking a Common Human Factors Language for the Development and Testing of Injection Devices
Conrad, Megan O; Laird, Molly E; Privitera, Mary Beth; Lemke, Melissa R.; Story, Molly Follette
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Survey Analysis on Comparative Use Human Factors Processes
Conrad, Megan; Privitera, Mary Beth; Laird, Molly E; Lemke, Melissa R
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Ophthalmic Drug-Device Combination Products – Comparative Analyses
Kim, Shinae
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A Taxonomy for Categorizing User Interface Design in Medical Device Development: Human Factors Application, Development Opportunities, and Potential Integration of AI and Machine Learning
Conrad, Megan O; Privitera, Mary Beth
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Perspectives on Current Quality and Bioequivalence Challenges for Complex Products
O’Reilly Beringhs, Andre; Delvadia, Renishkumar
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FDA’s Role in Regulating Products for Dermatology, Including Drugs, Biologics, Devices, and Cosmetics – With a Special Focus on Generic Drugs
Luke, Markham
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Establishing Equivalence of TDS and OIDPs
Ghosh, Priyanka
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FDA’s Role in Regulating Products for Dermatology, Including Drugs, Biologics, Devices, and Cosmetics – With a Special Focus on Generic Drugs
Luke, Markham