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40 articles
Warnings The FDA maintains a rigorous post-market surveillance system to protect public health through advanced Pharmacovigilance. Central to this is the FAERS (FDA Adverse Event Reporting System), a critical…
Trending topics In the current pediatric healthcare landscape, ensuring medication safety for children remains a critical challenge for global medical science. While adverse drug reactions (ADRs) are a major concern,…
Important Intranasal esketamine has been a focal point of psychiatric innovation for treatment of resistant depression, yet its transition from controlled clinical trials to broad real-world use continues to…
Important The European Medicines Agency (EMA) has updated its post-authorization guidance in November 2025, clarifying variation classifications for marketing authorization holders. These revisions address administrative, quality, clinical, and editorial…
Important The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has reaffirmed the strong safety profile of hepatitis B vaccines routinely given to all babies. These shots, part of…
Trending topics The U.S. Food and Drug Administration (FDA) has qualified the first artificial intelligence tool for drug development, specifically AIM-NASH, designed to aid pathologists in evaluating metabolic dysfunction-associated steatohepatitis…
Important Active safety surveillance plays a vital role in ensuring the safety of vaccines and medicines after they are approved and introduced into clinical use. This is especially important…
Trending topics The U.S. Food and Drug Administration (FDA) has announced the rollout of agentic artificial intelligence (AI) tools to all of its employees, marking a significant expansion of the…
Warnings An Expert Working Group (EWG) of the Commission on Human Medicines (CHM), advising the Medicines and Healthcare Products Regulatory Agency (MHRA), has completed an in‑depth review of how…
Important The Saudi Food and Drug Authority (SFDA) has signed a landmark agreement with Sweden’s Uppsala Monitoring Centre (UMC), connecting Saudi Arabia’s national pharmacovigilance database to the World Health…
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