The European Medicines Agency has published keenly-awaited revised EU guidance on what measures drug companies can employ to prevent or minimize the risks associated with their products, along with a revised addendum on how to gauge the effectiveness of such measures.
EMA Overhauls Guidance On Risk Minimization Activities
Drug companies may have to adjust their benefit-risk management strategies to ensure compliance with the European Medicines Agency’s newly revised guidance on how to develop and evaluate risk minimization measures.
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