Open Access. Powered by Scholars. Published by Universities.®

Medicine and Health Sciences Commons

Open Access. Powered by Scholars. Published by Universities.®

2020

Translational Medical Research

Doctor of Philosophy in Translational Health Sciences Dissertations

Articles 1 - 1 of 1

Full-Text Articles in Medicine and Health Sciences

Modelling Cross-Disciplinary Integration In Fda Multidisciplinary And Interdisciplinary Reviews For New Drug Products: A Phenomenological Descriptive Comparative Case Study, Kevin Bugin Dec 2020

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 …