An amendment that will impact regulations for testing the safety & efficacy of drugs and ingredients
Yesterday, the US Senate unanimously approved the FDA Modernization Act 2.0,
which was previously approved by the Lower House. This new bill which is expected to become a law soon aims to reduce testing with mammals, becoming a change accelerator for NemaLife, and increasing adoption of our cruelty-free platform.
This bill allows an applicant for market approval for a new drug to use methods other than animal testing to establish the drug's safety and effectiveness. Under this bill, these alternative methods may include cell-based assays, organ chips and microphysiological systems, sophisticated computer modeling, and other human biology-based test methods.
We invite companies in the foodtech, pharma, nutraceuticals, and microbiome space to reach out to us on how to obtain non-mammalian in vivo data and prepare for these changes in the regulatory landscape.