Massaro An N, Fletcher Elimika Pfuma, Madabushi Rajanikanth, Baer Gerri, Green Dionna
Office of Pediatric Therapeutics, Office of the Chief Medical Officer, Office of the Commissioner, US FDA (DG, ANM), Silver Spring, MD.
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US FDA (EPF, RM), Silver Spring, MD.
J Pediatr Pharmacol Ther. 2025 Feb;30(1):8-16. doi: 10.5863/1551-6776-30.1.8. Epub 2025 Feb 10.
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.
新生儿群体的药物研发仍然是医疗保健领域未被满足的需求。尽管激励措施和立法要求对增加儿科患者的药物研发有一定影响，但新生儿治疗学的进展面临着独特的挑战。本综述总结了相关的监管历史、临床、药理学和伦理考量，这些考量构成了新生儿药物研发的格局。还讨论了针对脆弱的新生儿群体推进安全有效药物的研究重点和未来方向。
