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Bad Pharma provides a hyper-critical account of the pharmaceutical industry's approach to conducting, publishing and using clinical research and development. However, its attack on the drug regulators is unfair and its examination of the medical…
September 14, 2020 – The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its workplan which sets actions to be delivered in 2020–2021. With the European Medicines Regulatory Network focused on the…
Systematic literature reviews are an essential component of the medical device clinical evaluation process. The EU Medical Device Regulation requirement for regularly updated systematic literature searches will increase the burden on the medical…
Already 1 year has passed since the date of application of the new Medical Devices Regulation (EU) 2017/745 (MDR), replacing the previous Directives 90/385/EEC and 93/42/EEC from 26 May 2021, while for the new In Vitro Diagnostic Medical Devices…
The EU Regulation 536/2014 included a requirement for companies to produce a Protocol Synopsis with a recommendation for a version in lay language. This requirement stated, among other things, a maximum length of two pages. This article outlines the…
Laws, regulations, pharmaceutical industry codes of practice, and other guidelines play an important role in ethical medical communications. When working on medical education prog - rammes and materials, a professional medical writer must not only…
Implantable medical devices (IMDs) have restored viable and meaningful lives to millions of people who would have otherwise continued to be severely restricted or suffered early death due to their pathologies. Research and development of IMDs are…
The EU’s new Medical Devices Regulation and In-vitro Diagnostic Device Regulation has integrated and reinforced the regulatory requirements for pre- and post-market clinical trials and positioned them as vital to ensuring the safety and performance…
The Chinese medical regulatory writing and medical science writing landscapes are chang - ing rapidly. Changes in regulatory reforms continue as China further strives to align its pharmaceutical industry with the world, which necessitates…
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…
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