Volume 23, Issue 3 - Non-Clinical Health Writing
Medical writing for in vitro diagnostics: A different approach for the ‘hidden’ side of healthcare
Author: Alisa M. Davis
Abstract
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.
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References
- Green SF. The cost of poor blood specimen quality and errors in preanalytical processes. Clin Biochem 2013;46:1175–9.
- Ec.europa.eu. European Union: Competitiveness and Innovation Programme (CIP) of the European Commission, 2007–2013 [cited 2014 April 28]. Available from: http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/about-ce-marking/index_en.htm
- Proposal for a Regulation of The European Parliament and of the Council on in vitro diagnostic medical devices. COM(2012) 541 final. Brussels: European Commission [26 Sep 2012].
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