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FDAnews Drug Daily Bulletin
July 31, 2012 | Vol. 9 No. 149
Pharmacovigilance Audits Will Take a Risk-Based Approach, EMA Says
Drugmakers whose products are authorized in the EU can expect regular, risk-based and independent audits of their pharmacovigilance systems, and they should be prepared to communicate any safety risks with regulators and health professionals, according to two new guidelines related to the 2010 pharmacovigilance law that took effect July 2.
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