Medical Countermeasures Development for Neonates

Author:

Humeniuk Rita1,Green Dionna1

Affiliation:

1. Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.

Abstract

As a nation, we remain vulnerable to threats posed by the intentional or unintentional use of chemical, biological, radiologic, and nuclear agents or emerging infectious diseases. Children represent an at-risk population and are particularly vulnerable to the effects of these agents because of their unique anatomical and physiologic features. Hence, it is imperative that their unique needs be considered and prioritized. In the current article, we highlight the status of medical countermeasure product development for children, with a specific emphasis on the neonatal population. The aim of this article is to discuss the evidence that has been used to support pediatric approval of medical countermeasure products by the US Food and Drug Administration under various regulatory pathways. Understanding the strengths and limitations of the data that support labeling of medical countermeasures for pediatric patients will help guide health care professionals providing care in the event of a chemical, biological, radiologic, and nuclear agent–related incident or emerging infectious disease outbreak.

Publisher

American Academy of Pediatrics (AAP)

Subject

Pediatrics, Perinatology, and Child Health

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