Federal drug regulators require certain safety testing — often involving animal studies — before new drugs can move into human clinical trials. A 2022 law already allows drug developers to use alternative methods instead, such as computer modeling or lab-grown tissue, but the FDA has not yet updated its regulations to match. This bill requires the FDA to publish a rule within one year replacing references to "animal" testing with the broader term "nonclinical testing" across roughly twenty sections of federal drug-review regulations. Drug and biologic companies, researchers, and patients waiting on new treatments would all be affected by the change. Notably, the bill lets the FDA issue this rule as immediately effective, skipping the normal requirement to justify bypassing advance public comment.
Transparency & Accountability
- Rulemaking public-comment safeguard — FDA can skip the usual good-cause justification for this rule
Congressional Summary
FDA Modernization Act 3.0This bill requires the Food and Drug Administration (FDA) to publish an interim final rule implementing a provision of the Consolidated Appropriations Act of 2023 that authorized the use of certain alternatives to animal testing to support investigational use of a new drug. The rule must replace references to animal tests, data, studies, models, and research with references to nonclinical tests, data, studies, models, and research throughout the FDA’s regulations governing investigational new drug applications. The rule must be published within one year of the bill’s enactment, and must take immediate effect as an interim final rule.
Legislative Subjects
Details
- Congress
- 119th
- Chamber
- House
- Status
- summarized
- Action
- Introduced in House
- Action Date
- 2025-04-10
- Date Added
- 2026-07-16
- Source
- Congress.gov →
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