A new era of regulations
We sat down with the FDA and leading industry experts to discuss the groundbreaking shifts in regulations around New Approach Methodologies such as Organ-Chips.
Is phasing out animal testing by 2030 realistic?
On April 10, 2025, the FDA issued an announcement that they plan to phase out animal testing in 3-5 years. In their roadmap for achieving this goal, they specifically cited Organ-Chips as one of the New Approach Methodologies (NAMs) that could help get us there.
To better understand the FDA’s new position, we recently sat down with Dr. Tracy Beth Høeg from the FDA to discuss this announcement and what it means for the pharmaceutical industry.
Here are the key takeaways.
Takeaway #1
There’s never been a better time to use NAMs
Reducing animal testing through the use of more human-relevant NAMs has become a top priority at the FDA, with overwhelming support from experts across all industries.
Takeaway #2
IND applications with NAMs will have priority review
Companies will get an answer within 1-2 months rather than 1-2 years.
Takeaway #3
The FDA wants you to call them
The FDA wants pharmaceutical industry sponsors to proactively reach out and discuss common sense ways to reduce the use of animals in preclinical testing, including the incorporation of NAMs such as Organ-Chips.
Takeaway #4
The FDA wants you to stop wasting money
The FDA is committed to stopping wasteful practices and wants to have proactive conversations with sponsors about how to drive more efficient program spend.
Takeaway #5
Transparency is in
The FDA will publish case studies and examples of how to use a NAM to replace or reduce animal testing in order to make it easier for companies to incorporate them into their own studies.
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