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FDAnews Drug Daily Bulletin
June 15, 2012 | Vol. 9 No. 118
EMA Chided Over Lack of Transparency in Pediatric Trials Waiver Process
The EU Ombudsman June 4 criticized the European Medicines Agency’s (EMA) lack of transparency and guidelines for deciding when to require drugmakers to carry out pediatric clinical trials. Ombudsman P. Nikiforos Diamandouros said the EMA was within its authority when it asked for a trial of candesartan to treat heart failure in children, but did not require similar studies of losartan and valsartan. However, the agency failed to ensure adequate transparency of its process and reasons for the decisions, Diamandouros said.
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