CERSI P.I. and Collaborator: James Polli, Ph.D.
FDA SMEs and Collaborators: Robert Heflich, Ph.D. and Lea McDaniel, MS (NCTR)


Project Overview

A workgroup of the International Life Sciences Institute (ILSI) Health and Environmental Sciences Institute (HESI) is developing an Organisation for Economic Co-operation and Development (OECD) Test Guideline (TG) for the in vivo Pig-a gene mutation assay. The TG will foster regulatory acceptance of the assay for conducting safety assessments.