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The FDA Modernization Act 3.0 would require the Food and Drug Administration to update its regulations to allow alternatives to animal testing in the drug approval process. Specifically, the bill would mandate that the FDA publish new rules replacing references to animal tests, data, studies, models, and research with references to nonclinical tests and alternatives throughout its regulations governing investigational new drug applications. This change would implement a provision from the 2023 Consolidated Appropriations Act that authorized such alternatives.
The bill would require the FDA to complete and publish these updated regulations as an interim final rule within one year of the bill becoming law, with the new rules taking effect immediately. This means the FDA would need to move quickly to revise its drug approval procedures to accommodate non-animal testing methods.
For everyday citizens, this bill could mean faster and potentially more ethical drug development processes. By allowing alternatives to animal testing, pharmaceutical companies might be able to bring new medications to market more efficiently, potentially reducing development costs and timelines. The change reflects growing scientific acceptance of non-animal testing methods for evaluating drug safety and effectiveness.
The bill has already passed the Senate and is currently being debated in the House of Representatives. If enacted, it would represent a significant modernization of how the FDA evaluates new drugs for investigational use.
AI-generated summary
Received in the House.
Dec 17, 2025
Held at the desk.
Dec 17, 2025
Received in the House.
Dec 17, 2025
Held at the desk.
Dec 17, 2025
Congress
119th Congress
Introduced
Feb 3, 2025
No CBO cost estimate has been published for this bill.
