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www.fdanews.com/articles/127275-eu-ombudsman-asks-ema-to-improve-transparency

EU Ombudsman Asks EMA to Improve Transparency

May 21, 2010
The European Medicines Agency (EMA) should review a 2008 citizen request for information on adverse drug reactions associated with a popular acne drug and take steps to make the reports publicly available, EU Ombudsman Nikiforos Diamandouros says in a draft recommendation. The agency also should consider possibilities for providing public access to the requested reports in any form, including electronic, he adds.
International Pharmaceutical Regulatory Monitor