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Other Updates Regulatory Affairs Newsletter Archive

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JALM is open access starting January 2026

I am writing to share a meaningful change coming to The Journal of Applied Laboratory Medicine (JALM). Starting with the January 2026 issue, JALM will become a fully open access journal. This new publishing model means changes for both authors and readers. What does this mean for you? Every article will be available for anyone to read, immediately upon publication—no subscriptions required, no login…
Ben Kemp
July 4, 2025
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New from CLSI: POCT16, 1st Edition Emergency and Disaster Point-of-Care Testing

Just Published! POCT16, 1st Edition Emergency and Disaster Point-of-Care Testing   In crises, every second counts. CLSI POCT16 delivers practical, step-by-step guidance for using point-of-care testing (POCT) devices in emergency, disaster, and urgent care settings—helping teams respond faster, more effectively, and with confidence.   Streamlined protocols for high-stress environments Improve patient care during disasters and outbreaks Support regulatory readiness and…
Ben Kemp
May 28, 2025
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WHO webinar: New guidance on WHO post-prequalification and post-EUL listing change applications for IVDs

WHO recently published a revised guidance and application form for reporting changes to WHO prequalified and emergency use listed in vitro diagnostic (IVD) products. A webinar introducing the new guidance took place on 19 May 2025 and gathered over 120 participants. If you couldn’t attend the webinar but are interested in this subject, please access the webinar recording https://who.zoom.us/rec/share/omC-19wYnD1iXMZtP_qbYNmvfEMNBzsMLxl4cuSqEhpVrgoksqf2nLfrUw1IZhKS.VcSuOwaoh6vk1IirPasscode: 7YK=s?3=…
Ben Kemp
May 23, 2025
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UK Research and Innovation Weekly Digest Bulletin

Simple test could better predict risk of heart disease Researchers have shown that a combination of two lipoprotein markers, measured in a simple blood test, can give more accurate information about individual risk of heart disease than the current blood cholesterol test.   Where we live affects our health and how we age Research is showing how environmental factors such…
Ben Kemp
May 23, 2025
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NHS Transformation Bulletin – May 2025

Standardising Preoperative Urine Testing in Urology GIRFT has released a second guide in its preoperative testing series, focused on delivering a standardised approach to screening, managing, and treating urinary infections prior to elective urology surgery. Developed by GIRFT’s anaesthetic and perioperative medicine (APOM) clinical and nursing leads, the guide is aimed at clinicians and managers who work across the elective pathway…
Ben Kemp
May 15, 2025
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