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
International Pharmaceutical Regulatory Monitor