S. 355: FDA Modernization Act 3.0

S. 355 tells the FDA to update its own regulations within 1 year so non-animal testing methods are clearly recognized across the drug review process.

Congress already changed federal law in 2022 so drug sponsors are not locked into animal testing before starting human trials. This bill says the FDA now has to bring its regulations into line by publishing an interim final rule through HHS.

The bill specifically orders the agency to replace references to "animal" tests, studies, models, and research with "nonclinical" language across a long list of drug, biologics, and over-the-counter regulations. It also imports the statutory definition of "nonclinical test" into key FDA definitions.

For companies using organ-on-a-chip systems, computational toxicology, or other alternatives, the practical change is clarity: the rules on the books would stop signaling that animal data is the default path.

The rule would take effect immediately once issued. That matters because it prevents a long lag between publication and use, though sponsors would still need the FDA to accept their evidence in practice.

The bill also makes a technical fix by renaming a duplicate subsection in existing law. The bigger question is not whether the wording changes — it is whether FDA reviewers treat non-animal evidence as a real option once the regulations are updated.