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UK MHRA Guidance: Use of Real-World Data in Clinical Studies to Support Regulatory Decisions (July 2025 Update)
In July 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released updated and expanded guidance on the use of...
Sharan Murugan
Jul 19, 20253 min read
UK MHRA's Guidance: Use of Real-World Data in Clinical Studies for Regulatory Decisions
The integration of real-world data (RWD) in clinical research is revolutionizing the pharmaceutical landscape. The Medicines and...
Sharan Murugan
May 22, 20252 min read
USFDA Guidance: Evaluation of Sex-Specific Data in Medical Device Clinical Studies (March 2025)
In March 2025, the U.S. Food and Drug Administration (FDA) released a final guidance titled “ Evaluation of Sex-Specific Data in Medical...
Sharan Murugan
Apr 5, 20252 min read
USFDA Guidance Updates: A Comprehensive Look at Recent Policies and Draft Recommendations
The U.S. Food and Drug Administration (FDA) has recently issued several key guidance documents addressing critical areas in...
Sharan Murugan
Jan 7, 20253 min read
USFDA Guidance: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products
FDA announced on Monday (29-January-2024) that a draft guidance for the industry is available titled, "Collection of Race and Ethnicity...
Sharan Murugan
Jan 31, 20241 min read