Challenges and opportunities for improving access to approved neonatal drugs and devices

• Published in: Journal of perinatology Vol. 42; no. 6; pp. 825 - 828
• Main Authors: Lewis, Tamorah, Wade, Kelly C., Davis, Jonathan M.
• Format: Journal Article
• Language: English
• Published: New York Nature Publishing Group US 01-06-2022; Nature Publishing Group
• Subjects: 692/308/575; 692/700/1538; Advocacy; Biological products; Clinical trials; Consent; Consortia; Design; Drug development; Drugs; Electronic health records; Families & family life; Hospitals; Humans; Infant, Newborn; Infrastructure; Innovations; International organizations; Leadership; Medical equipment; Medicine; Medicine & Public Health; Mortality; Neonates; Newborn babies; Parents; Patients; Pediatric Surgery; Pediatrics; Perspective; Product development
• ISSN: 0743-8346; 1476-5543
• DOI: 10.1038/s41372-021-01304-2

Neonatal drug and device development has lagged behind other patient populations. Oftentimes, providers are using drugs and devices without adequate study of safety and efficacy. Neonates deserve dedicated drug and device development programs, which will require novel approaches and unique collaborations between multiple key stakeholders. Legislative efforts, infrastructure, clinical trial methodology, and international collaborations have all contributed to improvements in neonatal drug and device development, but more work is still needed. Leadership from neonatologists, clinical care providers, and parents is essential to implement needed changes.