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

Area of Science:

• Neonatal pharmacology and medical device innovation.

Background:

• Drug and device development for neonates lags significantly behind other patient populations.
• Current clinical practice often involves using medications and devices without sufficient evidence of safety and efficacy in newborns.

Purpose of the Study:

• To highlight the critical need for dedicated drug and device development programs for neonates.
• To emphasize the necessity of novel approaches and multi-stakeholder collaborations in this field.

Main Methods:

• Review of legislative efforts impacting neonatal drug and device development.
• Analysis of infrastructure, clinical trial methodologies, and international collaborations.
• Identification of key stakeholders, including neonatologists, clinicians, and parents.

Main Results:

• Legislative actions, improved infrastructure, refined trial methods, and global partnerships have advanced neonatal product development.
• Despite progress, substantial work remains to ensure optimal safety and efficacy for neonatal therapeutics and devices.

Conclusions:

• Dedicated development programs are essential for advancing neonatal care.
• Continued collaboration among neonatologists, healthcare providers, and parents is vital for implementing necessary changes and improving outcomes for newborns.