EMA NAM Data Pilot: Eligibility and Evidence Readiness
A 2026 guide to EMA NAM pilot eligibility, four regulatory applicability areas, pathway selection, Module 2.4 package design, and evidence-readiness scoring.
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Articles tagged with “new-approach-methodologies”
Organ-on-a-Chip FDA Qualification: Current Sponsor Use
A 2026 data report on organ-on-a-chip FDA qualification, covering the ISTAND pathway, Emulate's Liver-Chip Letter of Intent, IND cases from Sanofi, Dianthus, and argenx, and FDA Modernization Act 2.0/3.0 status.
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This analysis explains the May 2026 FDA draft guidance on nonclinical safety studies for oncology biologics, single-species toxicology, and WoE approaches.
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.
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.