Ethics, policy, and legislation

Sarah A Carratt, Christina L Zuch de Zafra, Elias Oziolor, et al. An industry perspective on the FDA Modernization Act 2.0/3.0: potential next steps for sponsors to reduce animal use in drug development. Toxicological Sciences. 2025;203(1):28-34. doi:10.1093/toxsci/kfae122

Andrew S. Robertson, Nahid Latif, Imein Bousnina, et al. Accelerating adoption of new approach methodologies in regulatory decision making: an industry perspective. Nature Reviews Drug Discovery. 2025;24(6):401-402. doi:10.1038/d41573-025-00038-6

Tessel B. Wijne, Wouter P. C. Boon, Anne S. Kienhuis, Ellen H. M. Moors, Jarno Hoekman. Pursuing societal impact in research projects on NAM development: An analysis of routes to impact. NAM Journal. 2025;1:100050. doi:10.1016/j.namjnl.2025.100050

Ruxandra Malina Petrescu-Mag, Mathieu Vinken, Dacinia Crina Petrescu. Mapping the ethical and sustainable transition in toxicology: a bibliometric analysis and a review of new approach methodologies. Archives of Toxicology. 2025. doi:10.1007/s00204-025-04209-7

Jimin Liu, Xiang Zai, Xiaqing Tian, Jiaxuan Li, Shipeng Yan, Taiyi Wang. Practical implementation and impact of the 4R principles in ethnopharmacology: Pursuing a more humane approach to research. Frontiers in Pharmacology. 2025;16. doi:10.3389/fphar.2025.1543316

Angela Bearth, Nicolas Roth, Tom Jansen, et al. New approach methodologies in human health risk assessment across European regulatory frameworks: Status quo, barriers and drivers for regulatory acceptance and use. Environment International. 2025;196:109279. doi:10.1016/j.envint.2025.109279

Maximilian Andreas Storz, Elizabeth Dean. Status of animal experimentation in nutrition and dietetic research: Policies of 100 leading journals and new approach methodologies. Accountability in Research. 2025;32(8):1545-1563. doi:10.1080/08989621.2024.2398104

ISoOR Insight Team. Major Shift in U.S. Research Policy: CDC to End All Nonhuman Primate Experiments by 31 December 2025. Journal of Organoid and Bioscience. 2025;3(1). https://jobs.isoor.org/index.php/journal/article/view/60.

ISoOR Insight Team. NIH Shift Away from Animal-Only Research Signals a Major Opportunity for Organoids. Journal of Organoid and Bioscience. 2025;3(1). https://jobs.isoor.org/index.php/journal/article/view/61.

Maria D. Cabrera, Andrea C. del Valle. Organs-on-a-chip for global equity: a perspective from Guatemala on advancing biomedical research in resource-limited settings. Frontiers in Lab on a Chip Technologies. 2025;4. doi:10.3389/frlct.2025.1669220