FDA Releases New Guidance Recommending Alternatives to LLNA

22 Apr FDA Releases New Guidance Recommending Alternatives to LLNA

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.