Medical Literature Monitoring (MLM) – Current Status
The 1st September 2015 saw the rollout of the European Medicines Agency’s (EMA’s) much anticipated medical literature monitoring (MLM) service. The service was launched in summer 2015, focusing on the top 50 active chemical substance groups. Since last September, the...
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FDA Seeks Input on New Technology for Conducting Clinical Trials
Last October saw the publication of a request for comments from the FDA on new technologies and methods for conducting clinical trials. As clinical trials continue to evolve, the FDA wishes to identify new opportunities to study investigational products and...
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Periodic Safety Update Single Assessment (PSUSA) – An Overview
In this blog, we look at the Periodic Safety Update Single Assessment or PSUSA.
2015: Good Pharmacovigilance Practice (GvP) and Social Media
Editor’s Note: This article about GvP and social media is one of the most read articles ever on our website. With that in mind, we updated it in 2019 to take into account the myriad changes that had occurred in...
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CE Marking a Medical Device
CE marking a medical device and placing it on the market in the EU requires several steps that need to be taken. In this blog article, we look at the steps and the questions that you need to ask.
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Update on the new EU In Vitro Diagnostic Medical Device Regulation: Seven Key Changes
Editor’s note: This post was first published in November 2015. Since then we have written extensively on the issue of medical devices and the MDR/IVDR. You can read more about devices here. You will see that some of our comprehensive...
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EDMA Publishes a Position Paper on New EU IVD Regulation
In 2012, the European Commission proposed draft text for a new EU IVD regulation to replace the IVD directive 98/79/EC. Since publication, the text has undergone rounds of negotiation and revision, with the latest amendments being made by the European...
Acorn Regulatory to Exhibit at Med in Ireland – Dublin, October 29th 2015
Med in Ireland – October 29th 2015, Dublin Convention Centre, Ireland Acorn Regulatory is delighted to attend the Med in Ireland conference and exhibition on October 29th 2015. This biennial event is Enterprise Ireland’s largest medical technologies event, bringing together...
Medical Device Post-Market Obligations, a European Perspective: Part 2 – Assessing Product Changes
Last week, in the first part of this series, we outlined the post-market obligations for Manufacturers under the European IVD and medical device directives. In the second part of this series we are going to discuss another post-market topic – change...
DCP Applications To Be Accepted Only in eCTD format from July 1st 2015
Looking back on how far we have progressed from the standard paper submission one thing is clear – the age of the electronic common technical document is upon us. For instance, according to the eSubmission roadmap published, as of the 1st...
