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, children are frequently excluded from Clinical Research due to ethical complexities. This lack of dedicated data often forces clinicians to rely on adult safety data. However, a […]
Healthcare systems today generate enormous volumes of data from electronic health records, medical imaging, wearable devices, genomic databases, and real-time patient monitoring. While this data offers unprecedented opportunities to improve care, its real value emerges only when it is effectively analyzed. Big data analytics, combined with machine learning, is enabling healthcare systems to transform raw […]
The U.S. Food and Drug Administration (FDA) has announced a significant update to its approach to real-world evidence (RWE), removing a major limitation that has long restricted its use in drug and medical device reviews. Under new guidance for certain medical device submissions, the FDA will now accept RWE without requiring the routine submission of […]
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 (MASH) during clinical trials. This cloud-based system analyzes liver biopsy images to score key features like fat buildup (steatosis), liver cell damage (hepatocellular ballooning), inflammation levels, and […]
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 agency’s AI capabilities. Agentic AI refers to advanced systems capable of orchestrating complex, multi-step workflows by planning, reasoning, and executing tasks while adhering to built-in guidelines and […]
The U.S. Department of Health and Human Services (HHS) today took a historic step to bring evidence-based science back to women’s health. Following over 20 years of fear and misinformation around hormone replacement therapy (HRT), the U.S. Food and Drug Administration (FDA) is beginning the process of removing broad “black box” warnings from menopause-related HRT […]
A recent study carried out by UK’s Medicines and Healthcare products Regulatory Authority (MHRA) has revealed a huge variability in research methods associated with microbiome studies performed internationally. Therefore, making setting global standards for microbiome research methods a necessity that can’t be ignored. The study performed involved 23 laboratories across 4 continents and 11 countries […]
The Saudi Food and Drug Authority (SFDA) has launched the Regulatory AI System for Incoming Drugs (RASID), a smart service utilizing artificial intelligence to regulate controlled medications carried by travelers. Unveiled at the Global Health Exhibition (held in Riyadh from October 27–30), RASID marks a shift from traditional monitoring to proactive, data-driven protection. Developed by […]
The Saudi Food and Drug Authority (SFDA), led by CEO Dr. Hisham S. Aljadhey, has launched the Electronic Integration of Medications Risk Minimization Measures (RMMs) with several prominent hospitals. These hospitals include King Fahad Medical City, King Saud Medical City, Security Forces Hospital, King Abdulaziz Medical City, and Johns Hopkins Aramco Healthcare. This initiative was […]
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched three government-funded initiatives that aim to make medicine development and regulation safer and more efficient through the use of artificial intelligence (AI). Among these projects is a pioneering study focused on predicting harmful side effects that arise from interactions between multiple drugs before they reach […]
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