Peer-reviewed publication of clinical trials completed for pediatric exclusivity
DK Benjamin, PB Smith, MD Murphy, R Roberts… - Jama, 2006 - jamanetwork.com
ContextMuch of pediatric drug use is off-label because appropriate pediatric studies have
not been conducted and the drugs have not been labeled by the US Food and Drug …
not been conducted and the drugs have not been labeled by the US Food and Drug …
Is pediatric exclusivity working?
JS Li, PB Smith, RM Califf, DK Benjamin - Pediatric Health, 2007 - Taylor & Francis
Most drugs prescribed for children have not undergone pediatric testing; therefore, the data
on dosing, efficacy and safety that are available for adults are not usually available for …
on dosing, efficacy and safety that are available for adults are not usually available for …