We have successfully completed fertility and early embryonic development toxicity studies in rats and mice, embryonic–fetal development toxicity studies in rats, mice, and rabbits, and perinatal development toxicity studies in these species, with data accepted by the U.S. FDA. In addition, we have conducted enhanced perinatal development toxicity (ePPND) studies in cynomolgus monkeys, also accepted by the FDA. These accomplishments demonstrate that our comprehensive, reliable reproductive and developmental toxicity data comply with global regulatory standards and have supported the successful development of hundreds of innovative drugs.