Momentum behind New Approach Methodologies (NAMs) has accelerated rapidly in recent years. Regulators, industry, and academia […]
Qualification of New Approach Methodologies will improve investor appeal.
Microphysiological Systems (MPS) Are Beating Organoids in the NAMs Qualification Race
New Approach Methodologies are revolutionizing drug development.
Confused about what “NAM” really means? Explore the many definitions of New Approach Methodologies (NAMs), why regulators are standardizing terminology, and what it means for safer, more ethical drug development.
The qualification of a New Approach Methodology (NAM) through the FDA’s ISTAND Program represents a significant […]
Every successful regulatory submission for a New Approach Methodology (NAM) qualification is built around a clear, precise Context of Use (COU).
Explore the FDA ISTAND snapshot. See how NAMs, AI, and organ-on-a-chip technologies are advancing qualification under the FDA’s roadmap to reduce animal testing.
The FDA has made ISTAND a permanent qualification program. Learn how to qualify NAMs and novel Drug Development Tools and strengthen your FDA submissions.