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Translational Medical Research Commons™
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Himmelfarb Health Sciences Library, The George Washington University
Doctor of Philosophy in Translational Health Sciences Dissertations
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Modelling Cross-Disciplinary Integration In Fda Multidisciplinary And Interdisciplinary Reviews For New Drug Products: A Phenomenological Descriptive Comparative Case Study, Kevin Bugin
Doctor of Philosophy in Translational Health Sciences Dissertations
Cross-disciplinary integration is a key feature of interdisciplinary research and the collaborative form is often one of the desired outcomes of Team Science endeavors. In 2019 the FDA began rolling out a new interdisciplinary approach to their cross-disciplinary assessment of marketing applications, with the key feature being integrated, collaborative review documents (Woodcock et al., 2020). FDA’s assessment of new drug products to allow them to enter the marketplace is a critical translational activity to protect the US public’s health that requires team-based integration and transparency (Woodcock, 2018). And, while increased cross-disciplinary integration through enhanced collaboration and communication is sought through …