Federal Legislation and the Advancement of Neonatal Drug Studies

The Journal of Pediatrics: 10/29/12

The directive from the US Congress, through laws and regulations mandating that manufacturers of pharmaceuticals demonstrate proof that new drugs are both safe and efficacious in target groups, has been in place for 50 years.12 However, children and, in particular, neonates remain disproportionately underrepresented in the majority of drug clinical trials. To date, federal legislation has been slow to respond to the need for improvement in this regard, and it has only been in the last one and a-half decades that attempts have been made to rectify this unacceptable situation. Children remain therapeutic orphans, and it has taken the might of the federal government to include them in drug development processes.Read More