ATLANTA–(BUSINESS WIRE)–Axion BioSystems today announced that the FDA’s Center for Drug Evaluation and Research (CDER) has accepted the company’s letter of intent (LOI) into the Innovative Science and Technology Approaches for New Drugs (ISTAND) Program for its Human iPSC-Cardiomyocyte MEA Assay for Prediction of Clinical Cardiovascular Repolarization Risk. The submission represents the first stem cell-derived, functional cardiac safety assay accepted into the ISTAND program.
“FDA acceptance marks an important milestone—not just…