FDA Modernization Act 2.0 allows for alternatives to animal testing

Abstract

AbstractOn December 29, 2022, President Biden signed into law the FDA Modernization Act 2.0. The bill essentially refutes the Federal Food, Drug, and Cosmetics Act of 1938, which mandated animal testing for every new drug development protocol. While for the past century, the mandate was intended to ensure certain quality and safety standards for drugs and medical devices, recent advancements in science have begun to offer increasingly viable alternatives to animal testing. For certain areas such as organ replacement therapies, non‐animal testing may not prove to be an adequate alternative in the foreseeable future.