H.R. 2821
The FDA Modernization Act 3.0 (H.R. 2821) is a proposed law introduced in April 2025 by Representative Earl L. 'Buddy' Carter. Its main goal is to update existing regulations to allow drug developers to use alternative testing methods instead of traditional animal testing when assessing the safety and effectiveness of new drugs and medical devices. The bill requires the Secretary of Health and Human Services to publish an interim final rule within one year of enactment. This rule would update specific sections of the Code of Federal Regulations to replace references to 'animal' tests with 'nonclinical' tests and define 'nonclinical test' in various parts of the drug approval process.