Posts in FDA qualification pathway

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
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 13, 2026

NAMs Developers’ Number One Mistake: Poorly Defined Scope

2026 is already promising to be another huge year for the advancement of New Approach Methodologies […]
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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
December 10, 2025

NAM Your Price: Will the Next Biotech Investment Trend be New Approach Methodologies?

Qualification of New Approach Methodologies will improve investor appeal.
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by Michael Phelan
November 18, 2025

Microphysiological Systems (MPS) Are Beating Organoids in the NAMs Qualification Race

Microphysiological Systems (MPS) Are Beating Organoids in the NAMs Qualification Race
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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 21, 2025

Quality Systems: The Backbone of New Approach Methodologies Qualification

The qualification of a New Approach Methodology (NAM) through the FDA’s ISTAND Program represents a significant […]
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