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Medical writing for in vitro diagnostics: A different approach for the ‘hidden’ side of healthcare

Authors: Alisa M. Davis

Medical writing for in vitro diagnostics differs from writing for pharmaceutical products in several ways. The shorter development time and lifecycle of diagnostic assays, different regulatory requirements and approval times, and upcoming changes to European Economic Area regulatory requirements are a few challenges. In addition, the type of data from in vitro diagnostic studies and relevant forums for presenting scientific diagnostic data (independently from patient data) can significantly differ from data collected in pharmaceutical clinical trials.

Medical Writing. 2014;23(3):204–206

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