The FDA Modernization Act 2.0: Implications for drug development

By Dr Nicola Davies

On December 23 2022, the FDA Modernization Act 2.0 was passed with full support from both the US House of Representatives and the Senate.1 This act aims to improve the process for approving drugs and commits to significantly reducing the use of dogs, primates, and other animals in laboratory testing.

The FDA Modernization Act 2.0, signed into law by President Biden, includes a provision that repeals a long-standing requirement for animal testing of new drugs approved by the Food and Drug Administration (FDA). It allows researchers to ask the FDA for permission to use non-animal methods, such as cell-based assays and computer models, to study the safety and effectiveness of drugs.2