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The EMA, the FDA, and Health Canada head to head A recent issue of the New England Journal of Medicine carried an article comparing the regulatory review times of novel therapeutics by three different regulatory agencies (FDA, EMA, and Health…
An estimated 85% of efforts in biomedical research are wasted due to inefficiencies. This wastage represents a global financial loss of greater than US$200 billion per year, a barrier to practicing evidence-based medicine, and a considerable amount…
Patient-centred medicine has come out of the increasing importance of patients’ voices in disease management. As part of this, health related quality of life (HR-QoL) has become an important part of assessing treatment outcome and the quality of…
How results are reported influences how they are interpreted. Although P values have been granted great importance, they have no clinical interpretation. Rather, they are a measure of chance as an explanation for the results. Their either or…
Post-authorisation safety studies (PASS), whether interventional or, more commonly, non-interventional (NI), can be used by entities such as the European Medicine Agency´s Pharmacovigilance and Risk Assess ment Committee to oblige drug companies to…
The European Medicine Agency's draft policy on the publication of clinical trial data for consultation (POLICY/0070, EMA/240810/2013) is causing quite a stir. The draft policy provides for the publication of large parts of the clinical study reports…
Race and ethnicity are not clearly defined in biomedical literature and misaligned with genomics and epigenomic findings; the guidelines for consistent reporting in publications and regulations from health authorities are lacking. Minority…
As the authors of this book, Koen Cobbaert and Gert Bos, state “software joins the dots, by connecting patients with healthcare professionals and breaking down the boundaries between everyday objects, medical devices, and medicine.” As a medical…
Deadly Medicines and Organised Crime: How big pharma has corrupted healthcare by Peter Gøtzsche; Radcliffe Publishing, 2013. ISBN: 978-184619-884-7 (paperback). 24.99 GBP. 310 pages. Mastering Scientific and Medical Writing: A Self-help Guide by…
Brexit and the European Medicines Agency The British government has formally triggered Article 50, setting in motion Brexit and negotiations can begin in earnest. If before, politicians could gloss over the complexities, they are now obliged to…
Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.
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