Author(s): Vinhas de Souza M, KellerStanislawski B, Blake K, HidalgoSimon A, Arlett P,
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Abstract The occurrence of severe adverse events such as progressive multifocal leukoencephalopathy (PML) has the potential to limit the benefits of highly efficacious medicines being developed to fulfill unmet clinical needs across therapeutic areas. Following an Expert meeting in London in July 2011 (http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/09/WC500111562.pdf), a research agenda, highlighting methodological, clinical, and communication elements, to mitigate the risk and improve the management of drug-induced PML has been agreed upon.
This article was published in Clin Pharmacol Ther
and referenced in Journal of Vaccines & Vaccination