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A Pediatric Research Imperative: Addressing Neonates in Drug Development Through Understanding Neonatal Clinical
An N Massaro1, Elimika Pfuma Fletcher2, Rajanikanth Madabushi2
1Office of Pediatric Therapeutics, Office of the Chief Medical Officer, Office of the Commissioner, US FDA (DG, ANM), Silver Spring, MD.
Abstract:
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.
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