What Is the Biggest Barrier to Wider Adoption of New Approach Methodologies (NAMs) in Drug Development?

New Approach Methodologies (NAMs), including cell-based models, organoids, organ-on-chip systems and computer modeling, are playing a larger role in efforts to reduce animal testing in drug development.

In March 2026, the FDA issued draft guidance outlining how developers can validate NAMs for use in regulatory submissions. The framework focuses on intended use, relevance to human biology, technical reliability and the ability to support regulatory decisions.

In April, the FDA introduced a searchable resource showing where streamlined nonclinical approaches may be acceptable and outlined further collaboration with international regulators. In May, the Agency proposed reducing or replacing some animal studies for certain oncology drugs through weight-of-evidence assessments that may incorporate NAMs.

Putting these approaches into practice still raises questions around validation, technical capabilities, regulatory expectations and confidence in how well they predict human responses.

What do you believe is the biggest barrier to wider adoption of NAMs in drug development? Cast your vote below and join the conversation.