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There is great excitement following the announcements by the FDA and EMA around streamlining the biosimilar trial process. They promise to reduce the burden on developers and therefore increase the number of more afford...

2025 has seen both the EMA and the FDA publish new position papers and opinions on streamlining the trial process for biosimilars. On the surface, reducing reliance on comparative efficacy trials has the potential to sav...

The EU is moving toward MoA-based pediatric planning, following the precedent set by the RACE Act in the US. This approach promises better outcomes for children and more innovative medicines, but it requires early, integ...

The EU is moving toward MoA-based pediatric planning, following the precedent set by the RACE Act in the US. This approach promises better outcomes for children and more innovative medicines, but it requires early, integ...

Learn the pros and cons of different AI models for SaMDs. The right model and data training sets are essential to develop your AI-enabled device. Our latest whitepaper lays out the best practices for data and AI models...

What should you consider when choosing a training dataset for your AI-enabled SaMD? Our whitepaper has the answers. Learn about AI models and data best practices and plan for your FDA Pre-Sub. Download it today. https://...

PubsHub Journals & Congresses makes it faster and easier for your team to identify the ideal publication venue for your work. With advanced search capabilities across 5,500+ journals and 4,400+ congresses, and over 50 me...

PubsHub Journals & Congresses makes it faster and easier for your team to identify the ideal publication venue for your work. With advanced search capabilities across 5,500+ journals and 4,400+ congresses, and over 50 me...

Fast‑moving regulation demands clear, compliant storytelling. Ground campaigns in approved labelling and use the FDA’s newly published CRLs to pre‑empt pitfalls and sharpen claims—across every channel. Read ICON’s lat...

“Change is accelerating — and it shows no signs of slowing down. For pharmaceutical companies, this environment does not call for panic, it calls for preparation.” Fast‑moving regulation demands clear, compliant storyt...

ICON received a range of prestigious awards and brand recognition in 2025. Learn more: https://ow.ly/T0kr50XSPGH

ICON received a range of prestigious awards and brand recognition in 2025. Learn more: https://ow.ly/sBME50XSPGK