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News from the EMA - Volume 24, Issue

The articles included in this section are a selection from the EMA's news and press release archive for June–August 2015. More information on the work of the EMA can be found on its website: www.ema.europa.eu

News from the EMA - Volume 27, Issue

The articles included in this section are a selection from the European Medicines Agency’s News and Press Release archive from October 2017 to December 2017. More information can be found on the Agency’s website: http://www.ema.europa.eu/

News from the EMA - Volume 28, Issue

The articles included in this section are a selection from the European Medicines Agency (EMA)’s News and Press Releases archive from April 2019 to June 2019. More information can be found on the Agency’s website: www.ema.europa.eu

News from the EMA - Volume 34, Issue

Section Editor: Anuradha Alahari The items included in this section are a selection from the European Medicines Agency’s News and Press Releases archive. Medical Writing. 2025;34(2):84–86.

News from the EMA - Volume 31, Issue

The articles included in this section are a selection from the European Medicines Agency (EMA)’s News and Press Releases archive. More information can be found on the Agency’s website: www.ema.europa.eu. Anuradha Alahari (editor)

Writing in plain language for the Summary of Safety and Clinical Performance: Communicating medical device safety and performance data to patients - Volume 34, Issue

Effective communication with patients is paramount in the medical field, particularly in the medical device sector, where the complexity of information can create barriers to understanding. The Summary of Safety and Clinical Performance (SSCP) has…

The clinical development plan - Volume 31, Issue

The Medical Device Regulation (MDR) mentions the term “Clinical Development Plan” (CDP) only twice, both of which are in than the MDR into what the CDP entails and to propose the best strategies for a manufacturer to plan their medical…

Clinical evaluation reports: 6 years after the introduction of MEDDEV 2.7/1 revision 4 - Volume 31, Issue

MEDDEV 2.7/1 is the European guideline about the clinical evaluation of medical devices. The 4th revision, in 2016, updated how clinical evaluation should be conducted and reported, thus paving the way for clinical evaluation under the Medical…

Plain language summaries of clinical trial results: What is their role, and should patients and AI be involved? - Volume 33, Issue

Plain language summaries (PLSs) of clinical trial results are vital tools in the clinical development process for enhancing transparency and encouraging and facilitating patient engagement. The production of a PLS is now mandated in the EU for all…

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…

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Scope

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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