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MHRA Updates Comprehensive Guidance Framework for Clinical Trials in the UK (October 2025)
The UK’s Medicines and Healthcare products Regulatory Agency ( MHRA ) has issued a coordinated update to its suite of clinical trial...

Sharan Murugan
Oct 53 min read
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EMA Guidance: European Commission’s (EC) New Variations Guidelines
On 22 September 2025 , the European Commission published new variations guidelines  in the Official Journal of the European Union. These...

Sharan Murugan
Sep 222 min read
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USFDA Draft Guidance on Safety Labeling Changes: Streamlining Section 505(o)(4) Implementation
On September 19, 2025, the U.S. Food and Drug Administration (FDA) released its revised draft guidance, “ Safety Labeling...

Sharan Murugan
Sep 213 min read
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