This bill aims to update regulations on nonclinical testing methods by amending the Federal Food, Drug, and Cosmetic Act. It tasks the Secretary of Health and Human Services to publish an interim final rule within a year of enactment to replace references to ‘animal’ tests with nonclinical tests in the federal regulations. Also, it encompasses the addition of the definition of ‘nonclinical test’ to specific sections of the Act. The bill also includes technical amendments to the Act by designating a subsection related to clinical trial diversity action plans. If enacted, this bill will impact the methods and terminology used in nonclinical testing for FDA approval processes.
FDA Modernization Act 3.0
This 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.