EMA to revoke PIP class waivers in oncology; says more cancer trials needed in children
This article was originally published in SRA
Executive Summary
The European Medicines Agency's paediatrics committee (PDCO) is planning to revoke class waivers for paediatric investigation plans (PIPs) in some conditions on the grounds that the waivers are preventing the agency from requesting studies in children, especially in the field of oncology1,2.