EMA makes significant changes to paediatric drugs guide; reissues draft for consultation
This article was originally published in SRA
Executive Summary
The European Medicines Agency has reissued for consultation a draft guideline on the development of paediatric medicines after making important revisions to the initial document in light of feedback from stakeholders1. The new draft guideline is accompanied by a 331-page document in which the EMA outlines the concerns it had received from stakeholders and how it intends to deal with them2.