{Reference Type}: Journal Article
{Title}: The First Paediatric Use Marketing Authorisation: A Case Study.
{Author}: Watson J;Nowacki K;
{Journal}: Ther Innov Regul Sci
{Volume}: 49
{Issue}: 2
{Year}: Mar 2015
{Factor}: 1.337
{DOI}: 10.1177/2168479014537260
{Abstract}: The first Paediatric Use Marketing Authorisation was approved in Europe in 2011. This article describes the assessment procedure and the key regulatory issues that were addressed.