Rise for Animals examines the FDA’s September 21, 2026 direct final rule, which replaces terms like “animal tests” and “animal studies” with “nonclinical tests” and “nonclinical studies” throughout key drug-safety regulations, aligning agency regulations with the FDA Modernization Act 2.0 passed by Congress in December 2022. The organization describes the rule as a concrete win while cautioning that it is not final, can be reversed by future agency action, leaves animal research permissible, and may not change industry practice. The analysis calls for passage of the FDA Modernization Act 3.0 to place the change on statutory footing.
Key Highlights #
- The direct final rule is open for public comment until December 7, 2026; if the FDA receives significant adverse comments, it will withdraw the rule and proceed through the standard notice-and-comment process.
- The rule would not take effect until, at the earliest, February 4, 2027, and only if it survives public comment.
- The FDA Modernization Act 3.0 passed the U.S. Senate in December 2025, and the House passed its version in July 2026; the two chambers must still agree on a single bill before it can go to the President.
- The FDA Modernization Act 3.0 would direct the FDA to update its regulations to match the 2022 statutory changes within a year of enactment, regardless of how the comment period goes, and would make the change harder to undo than a reversible agency rule.
- The article criticizes Acting FDA Commissioner Kyle Diamantas’s framing of new approach methodologies (NAMs) as “complements” to animal studies, noting a double standard in which animal tests are presumed appropriate while NAMs must earn their place through validation.
- Rise for Animals urges supporters to contact their Senators to pass the House-approved FDA Modernization Act 3.0 without amendment so it can go directly to the President for signature.
Statements #
This is a concrete win, and it belongs to everyone who fought to make the FDA Modernization Act 2.0 law. But our work isn’t finished… The rule isn’t final. It can be reversed. Animal research remains just as permissible. Industry practice may not change.
- Lindsey Soffes, Rise for Animals
By turning a discretionary agency action into a congressional mandate, the FDA Modernization Act 3.0 would back FDA’s language with the force of law.
- Rise for Animals
About the Organizations #
Rise for Animals is a nonprofit organization working to end the use of animals in laboratories through advocacy, policy engagement, and public education.
Learn More #
Article: FDA Wants to Drop “Animal” from Its Rules. Let’s Lock It In.
FDA Press Announcement: FDA Updates Regulations to Advance Innovative Alternatives to Animal Testing