Industry Wants Fixes To EMA’s Guidance on Clinical Data Publication
Executive Summary
As the European Medicines Agency presses on with fine-tuning the guidelines supporting its landmark transparency policy on proactively publishing clinical data, industry says it is not entirely happy with the way that recent revisions have been introduced and will be looking for alternative solutions. Meanwhile, the EMA says there has been “a positive atmosphere of collaboration” with the companies whose data have been published so far and that it is creating a group to tackle the tricky concept of anonymization.
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