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Now Published: CLSI C65 | Biochemical Tumor Markers

New Publication! Strengthen Tumor Market Testing with CLSI C65   Biochemical tumor marker plays a critical role in diagnosis, monitoring, and clinical decision making. With increasing pressure on laboratories to ensure accuracy and consistency across preexamination, examination, and postexamination processes, the new CLSI C65 standard provides the guidance needed to reduce risk and improve confidence in patient results.   Practical…
Ben Kemp
March 2, 2026
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Use of legislative powers related to recalls and other market actions

Dear Members, TGA Australia have issued an update on use of legislative powers related to recalls and other market actions Guidance to help sponsors understand the legislative powers the TGA can use relating to market actions. View article...
Ben Kemp
February 27, 2026
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WHO Position Note on Accessories

Dear Members, WHO has issued a Position Note on Accessories Position Note on Accessories Published | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control) This provides guidance regarding accessories supplied with WHO Pre-Qualified Devices.
Ben Kemp
February 27, 2026
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NICE – Statement of intent – NICE’s approach ongoing evaluations ahead of proposed changes to NICE’s standard cost-effectiveness thresholds

Dear members, please see below update from NICE - Statement of intent - NICE's approach ongoing evaluations ahead of proposed changes to NICE's standard cost-effectiveness thresholds. Overview | Statement of intent on NICE’s approach to ongoing evaluations ahead of proposed changes to NICE’s standard cost-effectiveness thresholds | Guidance | NICE
Ben Kemp
February 27, 2026
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Consultation: TGA Annual Charge Exemption (ACE) Scheme Compliance Program Updates proposal 2026-27

Consultation: TGA Annual Charge Exemption (ACE) Scheme Compliance Program Updates proposal 2026-27 We have opened a consultation to provide industry and other interested stakeholders with an opportunity to comment on the our proposed updates to the ACE Scheme Compliance Program View article...
Ben Kemp
February 26, 2026
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UKRI strategy builds on UK’s strength and potential in AI

UKRI strategy builds on UK's strength and potential in AI   In its first AI strategy, UKRI sets out a bold plan to build on the UK’s incredible strengths and potential in areas including explainable AI, edge computing, human-in-the-loop systems, agentic AI and sustainable AI systems. The strategy will turn AI research into practical benefits for people – from real-world…
Ben Kemp
February 26, 2026