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‘Give Us More On Warning On Publishing Our Clinical Data,’ Industry Implores EMA

Executive Summary

Drug companies are worried that the European Medicines Agency is not giving them enough advance notice on when it will contact them to submit their redacted clinical reports under Europe’s landmark transparency policy on proactively publishing clinical data. The EMA, meanwhile, says it is considering a possible solution, that it is taking care to nurture companies that are going through the submission process, and that it is not too bothered about industry missing deadlines.

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Industry Wants Fixes To EMA’s Guidance on Clinical Data Publication

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