Articles tagged with “new-approach-methodologies”

FDA Oncology Biologics Guidance: Nonclinical Safety Studies

This analysis explains the May 2026 FDA draft guidance on nonclinical safety studies for oncology biologics, single-species toxicology, and WoE approaches.

50 min read

5/15/2026

fda guidance oncology biologics nonclinical safety animal testing reduction weight of evidence single-species toxicology new approach methodologies

AI Predictive Tools and Animal-Free Drug Discovery

Learn how AI predictive tools and animal-free testing methods (NAMs) are advancing drug discovery. Read this technical review of AAPS NBC 2026 innovations.

40 min read

5/3/2026

ai drug discovery animal-free testing new approach methodologies predictive toxicology in silico modeling organ-on-a-chip machine learning

FDA NAM Roadmap: In Silico Models and Animal-Free Testing

Analyze the FDA NAM roadmap for animal-free drug approval. Learn how advanced in silico models, AI tools, and organ-on-chip systems replace animal testing.

40 min read

4/18/2026

fda nam roadmap in silico models animal-free testing new approach methodologies organ-on-chip preclinical safety drug development fdama 2.0