Duration of Pediatric Clinical Trials Submitted to the US Food and Drug Administration

JAMA Pediatrics
January 2019, Vol 173, No. 1, Pages 3-112
http://archpedi.jamanetwork.com/issue.aspx

Original Investigation
Duration of Pediatric Clinical Trials Submitted to the US Food and Drug Administration
Kanecia O. Zimmerman, MD, MPH; P. Brian Smith, MD, MPH, MHS; Ann W. McMahon, MD, MS; et al.
JAMA Pediatr. 2019;173(1):60-67. doi:10.1001/jamapediatrics.2018.3227
This study characterizes the duration of clinical trials submitted to the US Food and Drug Administration for pediatric drug approvals, with a focus on drugs used for long-term therapy.
Safety and Immunogenicity of Early Bacillus Calmette-Guérin Vaccination in Infants Who Are Preterm and/or Have Low Birth Weights- A Systematic Review and Meta-analysis
Shiraz Badurdeen, MRCPCH; Andrew Marshall, DPhil; Hazel Daish, MRCPCH; et al.
open access
JAMA Pediatr. 2019;173(1):75-85. doi:10.1001/jamapediatrics.2018.4038
This systematic review and meta-analysis examines the safety and efficacy of bacillus Calmette-Guérin vaccination at birth or later points in infants who are preterm and/or had low birth weights compared with ones who are full term and/or had normal birth weights.