FDA roadmap to reducing animal testing: a regulatory and scientific paradigm shift in nonclinical safety assessment - PubMed
3 hours ago
- #animal-testing-reduction
- #FDA
- #NAMs
- The FDA roadmap aims to reduce animal testing in drug development by shifting to human-centric New Approach Methodologies (NAMs) like organoids, organs-on-chips, and AI tools.
- This paradigm shift addresses challenges of animal models, including poor translation, high costs, ethical issues, and biological differences, which contribute to clinical failures and delays.
- Key advancements include the permanent ISTAND program, human-centric validation principles, streamlined frameworks for biologics, and global regulatory alignment.
- Persistent challenges include uneven validation of toxicological endpoints, incomplete data sharing, and cultural inertia, requiring strategies to accelerate safe NAM adoption.