Accelerating adoption of new approach methodologies in regulatory decision making: an industry perspective

Andrew S. Robertson, Nahid Latif, Imein Bousnina, Donna Boyce, Kevin Carl, Sean P. Curtis, Jennifer Dudinak, Carlos O. Garner, Michael Garvin, Sabine Luik, Koen Nauwelaerts, Eddie Reilly, Michelle Rohrer, Katrin Rupalla, Jacintha Shenton, Jerry Stewart, Mark Taisey, Axel Vicart, Raymond C. Votzmeyer, Matthew P. Wagoner, Max Wegner, Kathy Williams
Nature Reviews Drug Discovery. 2025;24(6):401-402. doi: 10.1038/d41573-025-00038-6

Clear and harmonized regulatory guidelines are needed to realize the potential of new approach methodologies for improving the predictivity of nonclinical drug candidate assessment.

https://www.nature.com/articles/d41573-025-00038-6
Keywords
biomedicine
Biotechnology
Cancer Research
Medicinal Chemistry
Molecular medicine
Pharmacology/Toxicology
general
Library Collection(s)
Ethics, policy, and legislation
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