Tag Archives: Adverse Events

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The Importance of High-Quality Reporting of an SAE Case Report: The Tale of Two MedWatches

BlogBy Supplement Safety Solutions January 30, 2019

The narrative section of the MedWatch 3500A form is the heart of the SAE report, and should contain all important information about the case, presented in a reader-friendly fashion. The narrative is likely the first part of the MedWatch read by the medical reviewer (and possibly the only part!), and should be concise, well-written, and…

The Importance of Casualty

BlogBy Supplement Safety Solutions September 30, 2018

The assessment of causality – whether the supplement caused the adverse event (AE) – is a very important part of the safety assessment. Although the lawyers out there would argue that it’s very difficult (if not impossible) to prove that a supplement caused an event, there are some factors strongly in favor of causality.…