Health and Medical Administration Commons^™

Evaluating Integration In Collaborative Cross-Disciplinary Fda New Drug Reviews Using An Input-Process-Output Model., Kevin Bugin, Gaetano R. Lotrecchiano, Michael O'Rourke, Joan Butler

Clinical Research and Leadership Faculty Publications

Background/Objectives: The US Food and Drug Administration (FDA) is responsible for assessing safety (risks) and effectiveness (benefits) of new drug products using the data provided in a Sponsor's new drug product marketing application before they can be marketed. The FDA forms cross-disciplinary review teams to conduct these assessments. Recently, the FDA began implementing more interdisciplinary approaches to its assessments, reducing redundancy in review processes and documentation by increasing team integration around review issues.

Methods: Through a phenomenological descriptive comparative case study, the impact of FDA's new interdisciplinary approach on review team integration was compared with its traditional multidisciplinary review approach. …