Bill > S5002

This bill, known as the FDA Modernization Act 2.0, aims to allow for alternatives to animal testing for the purposes of drug and biological product applications. Specifically, it amends the Federal Food, Drug, and Cosmetic Act to replace the term "preclinical tests (including tests on animals)" with "nonclinical tests" in the requirements for investigational new drug applications. It also defines "nonclinical test" to include in vitro, in silico, and in chemico tests, as well as non-human in vivo tests, including animal tests or non-animal or human biology-based test methods. Additionally, it amends the Public Health Service Act to allow for the assessment of toxicity in biosimilar biological product applications to rely on or consist of such nonclinical tests.

https://www.congress.gov/bill/117th-congress/senate-bill/5002/all-info