The FDA has adopted ICH M11 CeSHarP, introducing a harmonized framework for clinical trial protocols. Discover the impact on sponsors and global studies.

The FDA has released a major update to its Bioequivalence Statistical Guidance, replacing the 2001 version. The new document introduces adaptive designs, modern statistical methods, guidance for highly variable drugs, NTI products, missing data handling and model-based approaches for generic drug development.

FDA opens consultation on a pilot program to assess artificial intelligence in early-phase clinical trials, focusing on efficiency, safety, and decision-making.