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Unleashing the Mini-Sentinel

Nature Reviews Drug Discovery volume 11, pages 255–257 (2012)Cite this article

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First data from the FDA's new active surveillance programme highlight how the system might influence drug development programmes.

The European Medicines Agency (EMA), meanwhile, is implementing new pharmacovigilance legislation later this year. Although its new rules have a broad scope (Box 1), they importantly also include measures to improve active surveillance. “The age of enhanced and active pharmacovigilance is here,” says Peter Arlett, head of pharmacovigilance and risk management at the EMA.

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  1. Asher Mullard
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Mullard, A. Unleashing the Mini-Sentinel. Nat Rev Drug Discov 11, 255–257 (2012). https://doi.org/10.1038/nrd3713

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