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Swissmedic Guidnce: A Closer Look at Marketing Authorisation Transfers, DHPC, and RMP Submissions
As the Swiss life sciences sector grows increasingly global and collaborative, Switzerland’s regulatory authority, Swissmedic , continues...

Sharan Murugan
4 days ago2 min read
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EMA’s CTIS Framework: Decoding the EMA Clinical Trial Information System-A Practical Guide for Sponsors
In an era of data-driven drug development, the European Medicines Agency (EMA) has launched a transformative regulatory framework : the...

Sharan Murugan
4 days ago2 min read
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USFDA Guidance: Drug Development for Myelodysplastic Syndromes (MDS)
Myelodysplastic syndromes (MDS) are a group of complex, clonal blood disorders that predominantly affect older adults and may progress to...

Sharan Murugan
Jul 52 min read
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UK Med Dev Guidance: How to Register Medical Devices with the MHRA and Digital Mental Health Technology Regulation
The regulatory landscape for medical devices and digital health technologies in the UK is evolving rapidly, reflecting the growing...

Sharan Murugan
Jul 53 min read
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USFDA’s Draft Guidance: Aluminum Content and Labeling for Small Volume Parenteral Drug Products in Parenteral Nutrition
Aluminum contamination in parenteral nutrition (PN) has long posed a silent but serious risk—especially to vulnerable populations like...

Sharan Murugan
Jul 23 min read
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EMA NDSG Work Plan: Inside the Network Data Steering Group Workplan 2025–2028
In an era where data drives decisions and innovation defines progress, the European Medicines Agency (EMA) and Heads of Medicines...

Sharan Murugan
Jul 23 min read
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