This week, the U.S. Food and Drug Administration (FDA) announced a landmark policy shift supporting the use of New Approach Methodologies (NAMs) for drug development — reducing or replacing animal testing in favor of more predictive, human-relevant models such as AI-based simulations, organoids, and global human safety data (FDA, 2025a).
While this initiative currently focuses on monoclonal antibodies and other traditional pharmaceuticals, the American Amnion Association (AaA) strongly recommends that the same regulatory modernization be extended to human-derived biologics — specifically human amniotic membrane.
“The FDA’s progressive move to replace animal testing in the development of monoclonal antibody therapies with more accurate, human-relevant methodologies is a significant and commendable step toward ethical, cost-effective, and scientifically advanced drug development,” Vice President of the AaA Theresa Hong said. “However, we believe the same logic and framework should also be applied to the evaluation and clinical development of human-derived biologics like amniotic membrane-based therapies.”
Human amniotic membrane is a naturally occurring, biologically active material sourced from consenting human donors — making it fundamentally human in origin, unlike monoclonal antibodies which are synthesized and require modeling to predict human compatibility (Niknejad et al., 2008).
“If the FDA is now encouraging non-animal testing methods to evaluate synthetic and engineered drugs, it is both reasonable and scientifically appropriate to extend these same principles to human biologics,” Hong added.
Advancing Innovation: Integrating Amniotic Membrane into NAM Framework
1. Human-Relevant from the Outset
Amniotic membrane is human tissue. Testing it in animals often results in limited translatability, as animal models may fail to replicate human-specific responses, especially in wound healing, immunomodulation, or tissue regeneration (Koob et al., 2014; Niknejad et al., 2008).
Utilizing human-based in-vitro models, such as 3D skin equivalents or organ-on-chip systems, provides a more accurate assessment of therapeutic potential and safety (Marx et al., 2016; Ingber, 2020).
2. Ethical and Logistical Considerations
Like monoclonal antibodies, amniotic products are often used in conditions where safety and efficacy are already supported by clinical use in other countries. Requiring redundant animal testing creates unnecessary ethical concerns and delays access to potentially life-changing therapies (FDA, 2025a).
By allowing NAMs, including real-world evidence, the FDA can facilitate safer, faster approval processes for these human-derived tissues.
3. Cost and Innovation Benefits
Reducing reliance on animal testing for amniotic membrane would lower R&D costs, remove regulatory hurdles, and encourage further innovation in regenerative medicine.
This aligns with the FDA’s stated goals of accelerating therapeutic development and ensuring public access to advanced, affordable treatments (FDA, 2025b).
4. Precedent for Modernization
The FDA’s move signals a broader modernization of regulatory science. If monoclonal antibody developers can now rely on organoid and AI-based methods, the same regulatory latitude should apply to developers of amniotic membrane-based therapies, particularly since the tissue itself is biologically compatible with human systems from inception (Marx et al., 2016; Ingber, 2020).
“If the FDA is ready to embrace a future where AI models, human organoids and global real-world data are central to drug approval, then it is entirely consistent — and necessary — to extend this future-forward approach to human-derived biologics like amniotic membrane, said AaA President Jerry Pascucci. “This shift will not only improve scientific accuracy and patient safety but also align regulation with the ethical and technological standards of modern medicine – a win-win for science and patients.”
References
- FDA. (2025a). FDA Launches NAMs Roadmap to Replace Animal Testing in Monoclonal Antibody Development. U.S. Food and Drug Administration.
- FDA. (2025b). New Approach Methodologies: Transforming Toxicology and Regulatory Science.
- Niknejad, H., Peirovi, H., Jorjani, M., Ahmadiani, A., Ghanavi, J., & Seifalian, A. M. (2008). Properties of the amniotic membrane for potential use in tissue engineering. European Cells and Materials, 15, 88-99.
- Koob, T. J., Lim, J. J., Massee, M., Zabek, N., & Denoziere, G. (2014). Properties of dehydrated human amnion/chorion composite grafts: implications for wound repair and soft tissue regeneration. Journal of Biomedical Materials Research Part B: Applied Biomaterials, 102(6), 1353-1362.
- Marx, U., Andersson, T. B., Bahinski, A., Beilmann, M., Beken, S., Cassee, F. R., … & Roth, A. (2016). Biology-inspired microphysiological system approaches to solve the prediction dilemma of substance testing. ALTEX, 33(3), 272–321.
- Ingber, D. E. (2020). Is it time for reviewer 3 to request human organ chip experiments instead of animal validation studies? Advanced Science, 7(2), 2002030.