NEWS, REPORTS & POSITION STATEMENTS 1. Challenges and opportunities for human OOC in FDA assessments and pharma pipelines The US Food and Drug Administration recently announced a plan to phase out animal-testing requirements for drug assessments based on advances in […]
NEWS, REPORTS & POSITION STATEMENTS 1. Endotoxin testing milestone reached with European Pharmacopoeia’s animal shift From 1 January 2026, EU pharmaceutical manufacturers will need to use advanced alternatives such as the Monocyte-Activation Test (MAT) or the Bacterial Endotoxins Test (BET) […]
NEWS, REPORTS & POSITION STATEMENTS 1. Mapping existing NAM‑related training initiatives across Europe Training and capacity building are essential for the successful regulatory uptake of New Approach Methodologies (NAMs), which is also a core focus of the NAMWISE project. CEHTRA […]
NEWS, REPORTS & POSITION STATEMENTS 1. U.S. Senate passes FDA Modernization Act 3.0 Last December, U.S Senate Republicans and Democrats united to pass the FDA Modernization Act 3.0 (FDAMA 3.0), reaffirming strong bipartisan support for the government-wide shift toward modern, […]
NEWS, REPORTS & POSITION STATEMENTS 1. Opportunities and insights from pharmaceutical companies on the current use of NAMs in nonclinical safety assessment To foster broader adoption of NAMs, the Biotechnology Innovation Organization surveyed pharma/biotech companies about NAM usage and collected […]