Acorn Regulatory’s Top 100 Articles

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… Read more

Risk Management Plans

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… Read more

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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… Read more

Medical Literature Monitoring

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…. Read more

DMF Deadline

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… Read more

Periodic Safety Update Single Assessment

Periodic Safety Update Single Assessment (PSUSA) – An Overview

In this blog, we look at the Periodic Safety Update Single Assessment or PSUSA.

CE Marking A Medical Device

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… Read more

In Vitro Diagnostic Medical Device Regulations Acorn Regulatory

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… Read more

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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…. Read more

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