Bravo, FDA For Retiring 'Animal Testing' In Favor Of 'Nonclinical'
By Ray Dogum, Chief Editor, Drug Discovery Online
On September 21, 2026, the HHS announced its shift to accelerate human-based research. This is a momentous moment for practical drug discovery. For many people working in this field, animal studies have been the ‘gold standard’ of preclinical research.
The NIH, FDA, CDC, and ARPA-H have made related statements supporting the move with their own initiatives. And there is a new webpage that lists 47 related HHS milestones that have been announced since 2025.
Remember, the graduation rate of your drug going from successful animal studies to FDA approval is generously less than 10%. The rise of NAMs has been a persistent effort by scientists and humanitarians worldwide. It’s good to see policymakers aligned with researchers like this.
FDA Rules To Replace “Animal” with “Nonclinical”
The FDA issued a direct final rule titled Nonclinical Testing Terminology, which aims to remove references to animal testing and implement the FDA Modernization Act, effective February 4, 2027.
All references of “animal” tests or studies will be replaced with “nonclinical”.
The rule also substitutes “nonclinical” for “preclinical” and “in vitro” for consistency in terminology.
The FDA doesn’t anticipate any adverse comments from the community on this rule because they deem the change “noncontroversial” and “not expected to affect industry practice.”
It will certainly affect industry practice; but not in a negative way. It doesn’t mean animal testing will disappear overnight but this paves a path for NAMs to become more significant in IND enabling studies.
Bring on the Organoids At The NIH
The NIH is backing this shift with real infrastructure: more than $88 million for biomedical research facilities, a $7 million challenge for quantum-enabled measurement in lab-based new approach methodologies, and a new Clinical Center laboratory combining standardized human organoids with robotics, AI, and advanced data tools.
It is also recruiting grant reviewers with human-based science expertise, exploring an annual public report on vertebrate animal use in NIH-funded research, and has closed its last intramural beagle laboratory while allowing grant funds to support animal retirement or rehoming.
CDC and ARPA-H Put New Approaches Into Practice
The CDC is substantially reducing its laboratory animal colony, working to place healthy non-human primates in a qualified sanctuary, and conducting more than a dozen studies using new approach methodologies to strengthen the nation’s response to public health threats.
ARPA-H, through its CATALYST program, is applying AI and computational modeling to predict drug safety earlier, optimize dosing, and reduce reliance on preclinical animal studies.
What These Changes Mean
Confidence around NAMs has yet to peak, but all this support from the HHS will certainly drive organoid and organ-on-chip adoption in the near-term and long-term future.
Now, when a biotech startup CSO or CMO is asked if they have leveraged any NAMs data in their IND package, they won’t, as confidently, be able to say “we just do what the FDA deems necessary” with a smirky smile as if these NAMs are toys for toxicology enthusiasts.
This transition will take time to permeate the scientific culture of biopharma R&D. But the direction is now difficult to dismiss. Human-based methods are moving from the margins toward the mainstream, and drug developers will increasingly need these more predictable models.