April 2020

FDA Releases New Guidance Recommending Alternatives to LLNA

April 22, 2020
FDA releases new guidance recommending the performance of alternative test methodologies in lieu of the murine-based Local Lymph Node Assay (LLNA) to assess skin sensitization potential for topically-applied drug products. This information can be found at https://www.fda.gov/media/135312/download, pages 7-8. IIVS offers multiple assays and provides guidance to companies and organizations interested in using non-animal approaches to evaluate this endpoint. Learn more about our skin sensitization testing capabilities at https://iivs.org/testing-services/assays/sensitization/ or contact us at clientservices@iivs.org....