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

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

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

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

Fred Schwaller. A mental-health crisis plagues PhDs — these evidence-led initiatives offer help. Nature. 2025. doi:10.1038/d41586-025-01083-2

U.S. National Institutes of Health. NIH to prioritize human-based research technologies. https://www.nih.gov/news-events/news-releases/nih-prioritize-human-based-research-technologies. Published 2025.

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

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

Kristifor Sunderic, Andrew M. Wright, Nicole Kleinstreuer, et al. Complement-ARIE: Catalyzing the development and adoption of new approach methodologies. NAM Journal. 2025;1:100026. doi:10.1016/j.namjnl.2025.100026

Andrea C. del Valle. Organs on chips could make biomedical research more equitable. Nature. 2025;644(8076):338-338. doi:10.1038/d41586-025-02569-9