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AI-enabled software as a medical device is advancing rapidly, but regulatory expectations are becoming more demanding across every major market. Our latest whitepaper explores: - FDA Pre-Submission expectations for AI-...

Latest issue now available. Join thousands of subscribers who have discovered the convenience of our free monthly publication, by signing up today. https://ow.ly/hTYQ50Zu7sT Compiled and collated by ICON’s Regulatory I...

The European Health Data Space (EHDS) is set to transform how real-world evidence is generated across Europe. In this article, ICON authors explore how CROs must adapt to a new landscape of secure data access, interoper...

As we recognise National Immunisation Awareness Month (#NIAM), it's important to remember that vaccine decisions for rare autoimmune conditions should be made on an individual basis. Discover key elements of a vaccine sc...

The second article in MedTech Insight's PPWR series explores one of the most misunderstood concepts in the EU's Packaging and Packaging Waste Regulation: the distinction between a packaging manufacturer and a producer. ...

The rapid emergence of immunotherapies in autoimmune disease is creating new opportunities and new statistical challenges. At this year's ASA Biopharmaceutical Section Regulatory Industry Statistics Workshop, Patricia A...

From MS to NMOSD to early Alzheimer's disease, neurologic mAbs are delivering proven clinical benefit. But as efficacy becomes less of a differentiator, what determines whether these therapies reach patients? In this art...

Great managers can make all the difference to your career and your day to day experience at work. At ICON, our managers play an important role in supporting people to grow, share their expertise and build confidence in ...

Europe is emerging as an attractive route to global market access for Chinese sponsors. Early consideration of EMA requirements can help avoid costly delays and improve approval success. Read the article: https://ow.ly...

Every successful clinical trial starts long before the first participant is enrolled. Site Selection and Activation is one of the most important, yet often overlooked, stages of clinical research. From identifying the r...

The EU's Packaging and Packaging Waste Regulation (PPWR) is set to transform how medical device packaging is managed across Europe. While some contact-sensitive packaging benefits from targeted exemptions, medical devic...

Preparing for Italy's new serialisation framework requires more than regulatory awareness. Marketing authorisation holders, manufacturers and supply chain partners will need to assess packaging configurations, validate ...