HAI Europe Urges EMA Not to Backtrack on Commitments to Clinical Trial Data Transparency

The European Ombudsman has publicly expressed her concerns about an apparent “significant change of policy” by the European Medicines Agency (EMA) regarding clinical trial data transparency. In a letter to the EMA on 13 May, 2014, and a subsequent press release on 16 May, the Ombudsman refers to draft documents produced by the EMA that indicate a turn in the Agency’s long-held commitment to the proactive publication of clinical trial data.

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