The FDA Modernization Act 2.0 was unanimously passed through the United States Senate on September 29, 2022, and officially passed through the United States House of Representatives on December 23, 2022 and was signed into law by President Joe Biden. It is a bipartisan bill, sponsored by both the Republican Party and Democratic Party. The FDA Modernization Act 2.0 removes a requirement from the original Food, Drug, and Cosmetic Act of 1938 (FDCA) that mandates animal testing for new drugs approved by FDA and includes a provision to eliminate a similar mandate for biosimilars regulated by the U.S. Public Health Service.

This bill also introduced $5 million to support an FDA alternative methods program to reduce animal testing.