Posts in NAMs regulatory acceptance

by Michael Phelan
March 10, 2026

What NAMs Can’t Do (Yet): Identifying Gaps

Momentum behind New Approach Methodologies (NAMs) has accelerated rapidly in recent years. Regulators, industry, and academia […]
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by Michael Phelan
February 12, 2026

Eliminating Animals in Research Is the Goal. Even If We Fail.

The flurry of attention New Approach Methodologies (NAMs) have recently received has come with a range […]
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by Michael Phelan
January 21, 2026

ISTAND SNAPSHOT: What ISTAND Technologies Reveal About the Future of NAMs

The FDA’s Innovative Science and Technology Approaches for New Drugs (ISTAND) Program is one of the clearest windows into […]
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by Michael Phelan
January 5, 2026

New Approaches, New Opportunities: NAMs News to Watch in 2026

Medical research saw a tectonic shift in 2025. The promise of New Approach Methodologies (NAMs) to […]
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by Michael Phelan
December 16, 2025

Animal-Free Medicine: NAMs Are Powering Human Clinical Trials Without Animal Research

How NAMs are powering animal-free clinical trials.
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by Michael Phelan
November 5, 2025

NAMs Crash Course: Everything You NEED to Know About New Approach Methodologies

New Approach Methodologies are revolutionizing drug development.
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by Michael Phelan
October 27, 2025

What’s in a NAM: Defining New Approach Methodologies in Regulatory Science

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.
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by Michael Phelan
October 6, 2025

FDA ISTAND Snapshot: The Future of Qualified NAM Technologies

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.
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by Michael Phelan
October 3, 2025

FDA Makes ISTAND Permanent: A Clear Pathway for NAMs and Novel Drug Development Tools

The FDA has made ISTAND a permanent qualification program. Learn how to qualify NAMs and novel Drug Development Tools and strengthen your FDA submissions.
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