The FDA has released draft guidance for NAMs Validation – Now what?

On March 18^th, the FDA published draft guidance on validating new approach methodologies (NAMs), including complex in vitro models (CIVMs). For a field long operating without a clear regulatory benchmark, this is significant and it demands a collective response. Crucially, this is still a draft, and the feedback window is a genuine opportunity to adjust the guidance, so it reflects real-world scientific practice.

Context of use:

AbbVie, Biogen, Incyte and Vertex will share how they align model development with research timelines, ensuring deployment decisions are deliberate so your team can close the gaps in IND submissions before they become blockers.

Human biological relevance:

Technical characterization:

Fit-for-purpose:

The 3Rs Collaborative's DILI Project will reveal how direct collaboration with the FDA is establishing confidence in fit-for-purpose models, accelerating the kind of industry-wide CIVM adoption your organization can get ahead of now.

Beyond the sessions themselves, the summit gives you a dedicated space away from a busy day in the lab to review the guidance with peers, consolidate your thinking, and submit comments that help the FDA build something the industry can work with.

Learn more about what’s on the agenda here: https://ter.li/yhnxk6s6

Source:

Hanson Wade Group - 11^th 3D Tissue Models Summit 2026