CIOMS Publishes Updated Glossary of ICH Terms and Definitions
The Council for International Organizations of Medical Sciences (CIOMS) has published Version 10 of its Glossary of ICH Terms and Definitions, consolidating terminology from current ICH guidelines and supporting greater consistency in regulatory communication across the life sciences sector.
Health Canada summarizes feedback on Draft Guidance for Decentralized Clinical Trials
Health Canada published feedback from its public consultation on Decentralized Clinical Trials, including topics related to digital technologies and data management.
FDA Adopts ICH M11 CeSHarP Guidance: What Sponsors Need to Know About the Future of Clinical Trial Protocols
The FDA has adopted ICH M11 CeSHarP, introducing a harmonized framework for clinical trial protocols. Discover the impact on sponsors and global studies.
ANVISA Publishes 2024–2025 Good Clinical Practice Inspection Metrics: What Clinical Trial Sponsors and Manufacturers Should Know
ANVISA’s new 2024–2025 GCP inspection report highlights critical findings in clinical trials, data integrity, electronic systems, SOPs, and investigational product management. Learn what manufacturers and sponsors should review.
FDA Launches One-Day Inspectional Assessments Pilot
The FDA has launched a pilot program introducing one-day inspectional assessments across medical products, biologics, clinical research, and food sectors to support more targeted and efficient oversight.
FDA launches consultation on AI use in early-phase clinical trials
FDA opens consultation on a pilot program to assess artificial intelligence in early-phase clinical trials, focusing on efficiency, safety, and decision-making.