title: Challenges and opportunities to enhance global drug development in neonates.
abstract: OBJECTIVE
  This study reviews the history of neonatal drug development, recent legislative efforts designed to facilitate the study of therapeutic agents in neonates, and future steps necessary to advance drug development.
  
  
  RESULTS
  Although many federal regulations have been introduced over the past 15 years to encourage pediatric and neonatal drug development, the majority of medications that are used in the Neonatal Intensive Care Unit are not approved by the Food and Drug Administration (FDA) for use in neonates. There are many challenges that investigators encounter in conducting neonatal clinical trials. The Critical Path Institute working in conjunction with the FDA has developed several consortia, including the International Neonatal Consortium and Pediatric Trials Consortium, to address these concerns and facilitate interactions of researchers, regulators, funding agencies, industry, and others across the globe to produce regulatory ready and high quality data for neonatal therapeutics.
  
  
  CONCLUSIONS
  Neonatal drug development is an area which deserves significant attention if we hope to continue to improve outcomes. With the help of international collaborations, it is possible to accelerate efficient and high quality neonatal research through multidisciplinary teams that share data, knowledge, and expertise to advance medical innovation and regulatory science.
authors.affiliation: Department of Pediatrics, Tufts Clinical and Translational Research Institute, The Floating Hospital for Children at Tufts Medical Center, Boston, MA, USA.
authors.forename: Alexandra M
authors.initials: AM
authors.lastname: Smith
authors.forename: Jonathan M
authors.initials: JM
authors.lastname: Davis
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence*; D015195:Drug Design; D055808:Drug Discovery / Q000458:organization & administration*; D004345:Drug Industry / Q000458:organization & administration*; D005260:Female; D014943:Global Health; D006801:Humans; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000188:drug therapy; D008297:Male; D020380:Needs Assessment; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration; D035862:Vulnerable Populations