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.

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.

The FDA has released new guidance on postapproval pregnancy safety studies for drugs and biologics, highlighting pregnancy registries, real-world evidence, and postmarketing surveillance expectations for manufacturers.

Health Canada eliminates reconsideration requests for priority review and NOC/c decisions from April 2026. Key regulatory impacts for drug sponsors explained.