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.
TGA Expands Recognition of UK Approved Bodies for Medical Devices and IVDs
The Australian TGA has updated its guidance to recognise UK Approved Bodies as comparable overseas regulators, potentially simplifying ARTG submissions for medical device and IVD manufacturers.