Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersPharmaceuticalRisk Management
Risk Management Plans – What You Need To Know
To address risk minimisation, healthcare companies are required to have RMPs (Risk Management Plans) in place to document identified and potential risks of a drug. A Risk Management Plan will include an Action Plan outlining risk minimisation activities that are...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticleseCTDFeatured NewsGemma RobinsonPharmacovigilance
Periodic Safety Update Single Assessment Updates
In December 2015, we published a pharmacovigilance article “Periodic Safety Update Single Assessment (PSUSA) – An Overview” which outlined the process the European Medicines Agency(EMA) take to monitor the safety of medicines in Europe. Periodic safety update reports (PSURs) are pharmacovigilance documents submitted...
Risk Management Plans (RMP) for Healthcare Companies
To address risk minimisation, Healthcare companies are required to have RMPs (Risk Management Plans) in place to document identified and potential risks of a drug. A RMP will include an Action Plan outlining risk minimisation activities that are carried out...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesClinical & MedicalFeatured NewsGemma RobinsonIndustry News
A Tightening of Regulations for Phase I Clinical Studies?
The Food and Drug Administration (FDA) has announced that they have launched a safety probe into fatty acid amide hydrolase (FAAH) inhibitors under investigation in the US. The investigation comes in the aftermath of a Phase I clinical trial in France, in which...
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...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesClinical & MedicalFeatured NewsGemma RobinsonPharmaceutical
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...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesFeatured NewsGemma RobinsonHow-To & ExplainersPharmaceuticalPharmacovigilance
Periodic Safety Update Single Assessment (PSUSA) – An Overview
In this blog, we look at the Periodic Safety Update Single Assessment or PSUSA.
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesFeatured NewsHow-To & ExplainersIVD DevicesMDD DevicesMedical Devices
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.
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesFeatured NewsIVD DevicesMDD DevicesMDRMedical Devices
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...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesFeatured NewsIVD DevicesMDD DevicesMedical Devices
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...
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