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Early benefit assessment of new drugs in Germany: Framework for submission of dossiers by pharmaceutical companies - Volume 22, Issue

For the early benefit assessment of new drugs in Germany, medical writers are involved in the preparation of dossiers submitted by pharmaceutical companies to the main decision-making body of the German statutory healthcare system, the Federal Joint…

Early benefit assessment of new drugs: The impact on healthcare in Germany - Volume 30, Issue

The early benefit assessment of new drugs was introduced in Germany in 2011. The main rationale was to support pricing negotiations between the statutory health insurance (SHI) system and the pharmaceutical industry. The early benefit assessment…

Some considerations on the safety evaluation section of clinical study reports for studies with anticancer drugs - Volume 21, Issue

The International Conference on Harmonisation (ICH) guideline E3 describes the structure and content of clinical study reports (CSRs). However, this standard structure should be interpreted according to the type of study and data, including…

New treatments for type 2 diabetes - Volume 21, Issue

Type 2 diabetes (T2D) has become a burden for society, and the incidence of the disease continues to increase. A range of therapies is available to control glycaemia in T2D patients; however, these drugs have undesired side-effects and there is a…

EMWA News - Volume 26, Issue

The 45th EMWA Conference in Cascais, Portugal, has recently finished and we are all waiting for the upcoming annual event in Barcelona, Spain, next Spring. In the meantime, the Executive Committee is working hard on improving what EMWA has to offer…

Preclinical research in drug development - Volume 26, Issue

The process of developing a novel drug is time consuming and costly. To increase the chances of successfully completing a clinical trial leading to the approval of a new drug, the choice of appropriate preclinical models is of utmost importance.…

Did minor flaws in a new drug reveal major flaws in company publication practices? - Volume 23, Issue

Pradaxa, a new drug for the treatment of blood clots, has been revealed to produce some negative side effects on a minor population of patients, according to a new study. However, the road leading to the publication of this study revealed that…

News from the EMA - Volume 26, Issue

Conditional marketing authorisations give patients access to important new medicines earlier January 23, 2017 – Conditional marketing authorisation (CMA) can speed up access to medicines for patients with unmet medical needs in the European Union…

Ins and outs of environmental risk assessments (ERA) of medicinal products for human use - Volume 31, Issue

An environmental risk assessment (ERA) is the process of evaluating the effects of drugs for human use on the environment. ERAs must accompany all new drug market authorisations in Europe. In this article, we discuss the current guidelines on ERAs…

The Webscout - Volume 23, Issue

What happens pre-approval? The theme of this issue made me wonder what it is that happens before approval of a new medication. Of course, it is clinical development, notably phase II and phase III studies. But many years have already passed before…

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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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