This bill updates the rules for testing drugs and treatments by replacing animal testing references with nonclinical testing. This change aims to modernize the process and improve how new medical products are evaluated.
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, and may make other changes to the regulations as appropriate. The rule must be published within one year of the bill’s enactment, and must take immediate effect as an interim final rule.
