A Pediatric Research Imperative: Addressing Neonates in Drug Development Through Understanding Neonatal Clinical Pharmacology

Drug development in the neonatal population remains an unmet need in health care. While incentives and legislative mandates have had some impact on increasing drug development in pediatric patients, the advancement of neonatal therapeutics faces unique challenges. This review summarizes relevant regulatory history, clinical, pharmacological and ethical considerations that characterize the landscape of drug development in neonates. Research priorities and future directions for advancing safe and effective medicines for the vulnerable neonatal population are discussed.