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.
Download the full article
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].
Visit the EMWA website
Search
Articles
Member Login
Links
Editoral Board
Editor-in-Chief
Co-Editors
Managing Editor
Victoria White
Deputy Managing Editor
Alicia Waltman
Associate Editors
Section Editors
Digital Communication
EMWA News
Gained in Translation
Getting Your Foot in the Door
Good Writing Practice
Alison McIntosh / Stephen Gilliver
In the Bookstores
Manuscript Writing
Medical Communications/Writing for Patients
Medical Devices
My First Medical Writing
News from the EMA
Out on Our Own
Regulatory Matters
Regulatory Public Disclosure
Teaching Medical Writing
The Crofter: Sustainable Communications
Veterinary Writing
Editors Emeritus
Lay out Designer
Chris Monk