The contributions of the European Medicines Agency and its pediatric committee to the fight against childhood leukemia.

ABSTRACT:

Background

Although the diagnosis of childhood leukemia is no longer a death sentence, too many patients still die, more with acute myeloid leukemia than with acute lymphoblastic leukemia. The European Union pediatric legislation was introduced to improve pharmaceutical treatment of children, but some question whether the European Medicines Agency (EMA) approach is helping children with leukemia. Some have even suggested that the decisions of EMA pediatric committee (PDCO) are counterproductive. This study was designed to investigate the impact of PDCO-issued pediatric investigation plans (PIPs) for leukemia drugs.

Methods

All PIPs listed under "oncology" were downloaded from the EMA website. Non-leukemia decisions including misclassifications, waivers (no PIP), and solid tu

SUBMITTER: Rose K 

PROVIDER: S-EPMC4640230 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature