News from the EMA - Volume 32, Issue

Anuradha Alahari (section editor)   EMA recommends revocation of authorisation for sickle cell disease medicine Adakveo OPEN framework extended to a wider range of medicines Global regulators agree on way forward to adapt COVID-19 vaccines to…

Regulatory Matters - Volume 26, Issue

Medical writers are often involved in the preparation of submission documents such as clinical overviews and clinical summaries. The submission of the application (or, in the case of drugs already approved, a variation or supplement) is an important…

Regulatory Writing - Volume 23, Issue

Regulatory documents are complex beasts, often requiring input from many different authors. Sometimes, different departments will be responsible for authoring certain sections and the role of the medical writer could perhaps be more accurately…

Medical Education - Volume 25, Issue

Regulatory Public Disclosure - Volume 27, Issue

Welcome to Medical Writing’s first regular section on regulatory public disclosure (RPD). In this fast-evolving area, individuals can feel it’s almost impossible to keep up with developments.

Regulatory Public Disclosure - Volume 28, Issue

In the world of regulatory public disclosure (RPD) things rarely stay the same for long. This regular RPD section in Medical Writing and EMWA’s RPD SIG help you keep up.

Regulatory Public Disclosure - Volume 34, Issue

This section provides important updates in the evolving world of the complex writing environment for regulatory medical writers.  Medical Writing. 2025;34(2):100–106. https://doi.org/10.56012/qbev3223

Update of the Consolidated Health Economic Evaluation Reporting Standards: CHEERS 2022 - Volume 31, Issue

If economic evaluations are to be used by researchers and healthcare decision makers, they need to be adequately reported. This article discusses the update of the Consolidated Health Economic Evaluation Reporting Standards (CHEERS 2022), the main…

Value of medical writing: The regulatory writer's perspective - Volume 31, Issue

The American Medical Writers Association formed a working group in 2020 focused on understanding and communicating the value that regulatory medical writers contribute to project teams, companies, and the wider research community. The working…

Gained in Translation - Volume 24, Issue

Welcome to my second Gained in Translation editorial! Translation consulting networks are an interesting ‘assisted-translation tool’, which have had a remarkable appeal for professionals in the field since the late 1990s. Newsgroups, online…