%0 Journal Article
%T The First Paediatric Use Marketing Authorisation: A Case Study.
%A Watson J
%A Nowacki K
%J Ther Innov Regul Sci
%V 49
%N 2
%D Mar 2015
%M 30222413
%F 1.337
%R 10.1177/2168479014537260
%X 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.