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

Year: 2025

Type: article

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.

Source: The Journal of Pediatric Pharmacology and Therapeutics

DOI: 10.5863/1551-6776-30.1.8

Authors: An N. Massaro, Elimika Pfuma Fletcher, Rajanikanth Madabushi, Gerri Baer, Dionna Green

Institutions: United States Food and Drug Administration, Center for Drug Evaluation and Research

Language: English

Topic: Pharmaceutical studies and practices

Subfield: Pediatrics, Perinatology and Child Health

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: green

OpenAlex ID: W4407426914