Applying Regulatory Science to Develop Safe and Effective Medicines for Neonates: Report of the US Food and Drug Administration First Annual Neonatal Scientific Workshop, October 28-29, 2014. (September 2015)

• Record Type: Journal Article
• Authors: Offringa, Martin; Davis, Jonathan M.; Turner, Mark A.; Ward, Robert; Bax, Ralph; Maldonado, Sam; Sinha, Vikram; McCune, Susan K.; Zajicek, Anne; Benjamin, Daniel K.; Bucci-Rechtweg, Christina; Nelson, Robert M.
• Is Part Of: Therapeutic innovation & regulatory science. Volume 49:Number 5(2015:Sep.)
• Page Start: 623
• Page End: 631
• Publication Date: 2015-09
• Subjects: extrapolation -- biomarkers -- clinical outcomes -- adaptive designs -- pediatric trials; Drugs -- Periodicals; Pharmacology -- Periodicals; Drugs -- Research -- Periodicals; Drugs -- Testing -- Periodicals; 615.1
• DOI: 10.1177/2168479015597730
• Languages: English
• ISSNs: 2168-4790

Abstract

The First Annual Neonatal Scientific Workshop focused on the needs of the neonate by addressing the basic question: what information is required to inform decision making both at the regulatory level and at the bedside? Priority therapeutic areas include neonatal lung, brain, and gastrointestinal injury, retinopathy of prematurity, sepsis, and neonatal abstinence syndrome. Scientific progress in these therapeutic areas, regulatory standards, and the acceptable design and conduct of clinical trials must be aligned. This report will review potential approaches to enhancing neonatal drug development.