How CDC is promoting a clear communication culture - Volume 24, Issue

Both the federal Plain Writing Act and the mission of the US Centers for Disease Control and Prevention (CDC) to protect and promote people's health require CDC to communicate clearly so that people can understand and act on the important health…

News from the EMA - Volume 23, Issue

Update from the European Medicines Agency on development of its policy on publication and access to clinical-trial data   From the European Medicines Agency, 13 November 2013 – The European Medicines Agency is currently reviewing and analysing…

Regulatory writing - Volume 21, Issue

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…

My First Medical Writing - Volume 27, Issue

We all have been at the first stages of our careers, knowing what we want to do but without much experience. This is the case of many aspiring medical writers who come out of academia with a burning desire to becomemedical writers but without much…

The Light Stuff - Volume 22, Issue

A call to abandon the useless anachronism of the ‘define at first use’ rule for abbreviations Definitions CTD – Common Technical Document (dossier submitted for marketing authorization) eCTD – Electronic Common Technical Document QC – Quality…

Working with authors to develop high-quality, ethical clinical manuscripts: Guidance for the professional medical writer - Volume 23, Issue

One measure of career success for clinical researchers is reporting their findings in a peer-reviewed journal. Writing a clinical manuscript that has impact and relevance to their intended audience is crucial for publication success. However,…

ICMJE requirements for sharing individual participant data from interventional clinical trials - Volume 28, Issue

Sharing of deidentified/anonymised individual participant data is rapidly becoming the norm. The International Committee of Medical Journal Editors recently implemented requirements for data sharing as a condition for considering publication of…

Do you have what it takes to be a mentor or be mentored? - Volume 30, Issue

A skilled mentor can positively impact a mentee’s personal and professional development. A successful mentor-mentee relationship is contingent on mentor and mentee attributes, trust, and respect, and fit based on shared values and working style. To…

Medical Communications and Writing for Patients - Volume 30, Issue

Dear All,

As I write this, at least some of us are likely to still be in some form of lockdown or quarantine. I pray that you and your families are all managing to stay as sane as possible, and I sincerely hope that you all stay safe and healthy.

I…

Allergen immunotherapy in the European regulatory environment - Volume 27, Issue

Allergen immunotherapy (AIT) modulates the immune system to prevent and relieve allergic symptoms. Unlike allergen avoidance and medication to control symptoms, AIT targets the underlying pathophysiology of allergic diseases. AIT is now considered a…