FDA ISTAND Archives - InnovApproach Consulting

by Michael Phelan

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

Momentum behind New Approach Methodologies (NAMs) has accelerated rapidly in recent years. Regulators, industry, and academia […]

0

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 […]

0

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 […]

0

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.

0

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.

0

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

0

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.

0

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 […]

0

by Michael Phelan

October 13, 2025

Context of Use: The Three Most Important Words in NAM Qualification!

Every successful regulatory submission for a New Approach Methodology (NAM) qualification is built around a clear, precise Context of Use (COU).

2

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.

0