Acorn Regulatory’s Top 100 Articles

Post authorisation safety studies (PASS) are defined in Article 1(15) of Directive 2001/83/EC as studies carried out after a medicine… Read more

We are taking a look at 4 factors to consider when planning to in-licence an eCTD dossier. When acquiring an… Read more

Type I Variations to a Marketing Authorisation are surprisingly difficult. The procedure that many people perceive to be a simple… Read more

Perhaps one of the most frequently asked questions that our team members get is “how do you get started in… Read more

The introduction of the new medical device regulations in May 2020 will bring significant changes to the way that we… Read more

We consistently receive questions regarding the steps required when applying for a marketing authorisation (MA). In this article we aim… Read more

The advent of the new Medical Devices Regulation (MDR 2017/745) is a cause of much concern for manufacturers and others… Read more

The eSubmission roadmap is filled with significant dates that can impact on your business. Here, we look at developments on… Read more

In 2015 we looked at the emerging role of social media in pharmacovigilance. Revisiting the topic over 3 years later… Read more