The FDA recently released new draft guidance on the use of New Approach Methodologies (NAMs) in drug development, marking another important step toward human-relevant, non-animal models. ✨
The guidance outlines how in vitro systems, organ-on-chip models, and computational approaches can be integrated into regulatory submissions, with a strong focus on human relevance, reproducibility, and clearly defined contexts of use. 🔬
A key takeaway is the increasing need for standardized, scalable, and well-characterized systems to generate reliable and actionable data. ⚙️📊
At VitrofluidiX, we are developing integrated organ-on-chip platforms designed to enable reproducible, real-time, and human-relevant data generation – aligned with this broader industry shift.
This development reinforces what many in the field already recognize: the future of drug development will be more predictive, data-driven, and human-centered. 🚀
👉 See the full article:
https://lnkd.in/eB9Nq2UA