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Don't Let Sponsors Downplay Genuine Safety Concerns At Public Hearings, HAI Tells EMA

This article was originally published in SRA

Executive Summary

After the European Medicines Agency's pharmacovigilance committee (PRAC) finalized rules on how it would conduct public hearings to support the safety review of certain marketed medicines earlier this month1-3, medicines advocacy group Health Action International said that it welcomed the move, but warned that drug sponsors should not be allowed to downplay genuine safety concerns at such hearings.


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