The 4th edition of the Guide to Quality in Analytical Chemistry, has been published by Eurachem on 6 February 2026. This widely used guide provides laboratories with practical best-practice guidance for analytical operations, covering both qualitative and quantitative...

The ICH M15 Guideline, General Principles for Model-informed Drug Development, has been adopted (Step 4 of the ICH harmonisation process) and will now enter the implementation phase (Step 5).  Prior to the development of the M15 Guideline, a lack of common standards...

  FDA is issuing this guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality management system. This guidance: · Describes “computer software...

The FDA’s Center for Drug Evaluation and Research (CDER) has released its 15th annual New Drug Therapy Approvals report, offering a useful snapshot of the pace and direction of drug development in 2025. In 2025, CDER approved 46 new drugs never before approved or...