FDA rewrites its rules so drug safety testing no longer defaults to animals
The FDA has updated its drug regulations to make clear that developers may use non-animal methods, such as tests on human cells, organs-on-chips and computer models, where appropriate to show a drug or biologic is safe before human trials. The direct final rule, announced Sept. 21, replaces "animal tests" with "nonclinical tests" throughout the rules. It does not ban animal studies, change evidence standards or add costs, the agency said. The FDA also launched a database of 25 examples. Comments are open until Dec. 7; unless significant objections arrive, the rule takes effect Feb. 4, 2027.
The wall: FR notice unread
Tier: Confirmed (dates reported via trade sources)
Sources
- fda.gov/news-events/press-announcements/fda-updates-regulations-advance-innovative-alternatives-animal-testing
- allsci.com/news/regulatory-policy/fda-nonclinical-testing-terminology-issues-direct/
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