Features

18 March 2013

Assessing Benefits Versus Risks in Europe--the New Focus in Pharmacovigilance

By Joerg Seebeck & Siegfried Schmitt

Benefit:risk (B:R) assessment is a critical step in the process of approving a drug and in re-assessing an already marketed drug, in the case of newly identified important safety signals. B:R assessment is a holistic process that requires data from different sources to be reviewed to reach a decision on whether a drug’s benefits outweigh its risks. [Read More...]

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22 June 2012

Innovation Leads to Transformation in Regulatory Agencies' Evaluation of Benefit-Risk

By Kiley DePolo and Elaine Taylor

Recent International Conference on Harmonisation (ICH) guidelines, European legislation and proposed elements of US legislation (PDUFA V) are pointing the way to changes in the way regulatory authorities are considering benefit-risk. This article discusses pending innovations at the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), and how they stand to impact the industry. [Read More...]

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