FDA Modernization Act 3.0
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Summary
The FDA Modernization Act 3.0 requires the FDA to publish an interim final rule within one year that replaces references to 'animal' tests with 'nonclinical' tests in FDA regulations governing drug development and approval. The rule would amend multiple sections of the Code of Federal Regulations to align with amendments made by the Consolidated Appropriations Act of 2023, which expanded the types of nonclinical testing methods the FDA can accept for drug applications. The bill also makes a technical correction to resolve a duplicate subsection designation in the Federal Food, Drug, and Cosmetic Act.
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