BioCentury
ARTICLE | Politics & Policy

EU Ombudsman critical of EMA decision in pediatric waiver case

June 8, 2012 12:28 AM UTC

The EU Ombudsman concluded EMA failed to provide adequate transparency and reasoning in its decision to waive pediatric trial requirements for only two of three angiotensin II receptor (type AT1) antagonists. The Ombudsman recommended drafting guidelines for how EMA's pediatric committee analyzes waiver requests and improving documentation of committee decisions. ...