This bill tells the FDA to update its rules so drug makers can use certain non-animal methods (like lab-grown cells or computer models) to support early-stage drug testing. The FDA must publish these changes within one year, and the updates take effect right away once published. The rule also swaps out many mentions of “animal” tests in FDA regulations with “nonclinical” tests and adds a clear definition of “nonclinical test” to several FDA rule parts. This may reduce animal testing while keeping safety checks in place .

It does not change who approves drugs or lower safety standards; it focuses on how early evidence can be gathered. The FDA may make additional related edits to keep all the rules consistent .

• Key points
  • Who is affected: Drug developers, researchers, and indirectly patients and animals .
  • What changes: FDA must allow certain non-animal “nonclinical” tests and update many regulations to reflect that; definition of “nonclinical test” is added to multiple rule sections; FDA can make other needed edits .
  • When: The rule must be published within one year of enactment and takes effect immediately upon publication as an interim final rule .