The FDA launched AEMS, a unified platform that replaces fragmented legacy databases to enable real-time adverse event reporting.

On March 11, the FDA launched a unified platform for analyzing adverse event reports, replacing a fragmented infrastructure that had long-impeded effective postmarket surveillance.¹ Known as the FDA ...

The FDA has launched a new adverse event reporting system that will consolidate several systems it has for reporting different types of adverse events, the agency announced Wednesday. The new system, ...

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Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have revolutionized the management of metabolic diseases, offering substantial benefits in glycemic control, weight reduction, cardiovascular ...

Every life sciences company knows that patient safety is non negotiable, but the way safety is managed—and the value ...

What Is Safety Data Overload in Pharmacovigilance?Safety data overload in pharmacovigilance refers to the situation where drug‑safety teams are inundated with an ever‑increasing volume of individual ...

Novo Nordisk issued a response to an FDA warning letter that cited serious violations in how the company tracked and reported adverse drug events for several of its medicines. Included in the ...

COVID-19 and prevalence of venous thromboembolism among cancer patients: A nationwide inpatient sample analysis. This is an ASCO Meeting Abstract from the 2023 ASCO Annual Meeting I. This abstract ...

Naqash et al 1 reported major adverse cardiac events (MACEs) with immune checkpoint inhibitors (ICI) through the clinical trial database of the National Cancer Institute (NCI). As underlined by the ...