Last mentioned: Mar 20, 2026
Hybrid Submission Standards
Expected formalization of regulatory pathways that prioritize NAM data over animal data for specific drug classes.
OOC Commercialization
Widespread adoption of organ-on-a-chip systems in early-stage pharmaceutical R&D for toxicity screening.
EU Regulatory Shift
The European Parliament and EMA accelerate roadmaps for the phase-out of animal use in regulatory testing.
FDA Modernization Act 2.0
President Biden signs legislation removing the requirement for animal testing for biosimilars and new drugs.
The pharmaceutical industry is navigating a historic shift as the FDA Modernization Act 2.0 removes the mandate for animal testing in drug development. However, while technologies like organ-on-a-chip and AI offer higher human predictivity, they currently lack the systemic complexity required to fully replace animal models in late-stage safety assessments.