FDA updates rule to encourage alternatives to animal testing
Posted on September 30th, 2026
FDA is increasingly encouraging alternatives to animal testing during preclinical product development.
On Sept 22, 2026, FDA updated its regulations to “clarify that non-animal methods can be used where appropriate for testing” drugs prior to or alongside clinical testing. The rule introduces the term “nonclinical testing” to replace “animal testing” as well as terms like “preclinical” and “in vitro” to indicate that multiple methods can be used to generate safety information for regulatory submissions. As innovative methods like organs-on-chips, in silico models, and other new approach methodologies (NAMs) are progressed and validated, FDA is recognizing that it needs to keep up with technology development in its regulation and evaluation of new products.
In addition, CDER released guidance suggesting areas where “streamlined nonclinical programs” can be used during drug development, including the use of NAMs for safety and toxicology studies.
Through these updated regulations, FDA and CDER are aiming to reduce the use of animal testing in drug development, a goal the agency set in April 2025.
What constitutes a nonclinical test?
Read more in the FDA announcement here.
Permalink: https://sparkmed.stanford.edu/fda-updates-rule-to-encourage-alternatives-to-animal-testing/