Regulatory

The integration of artificial intelligence (AI) in healthcare is rapidly advancing, promising significant improvements in patient care and operational efficiency. Nonetheless, as this technological leap transforms medical practices, it also raises critical ethical considerations, particularly

In an effort to crack down on perceived inadequacies in the oversight of nonprofit hospitals’ charitable activities, the state of Montana has rolled out new rules aimed at closing long-standing gaps. This move stems from a legislative audit conducted more than four years ago, which critiqued the o

Imagine a world where the air we breathe, the water we drink, and the food we eat are all unchecked, teeming with unseen hazards. For many, this is a nightmarish scenario, yet it highlights the importance of regulatory bodies such as the Environmental Protection Agency (EPA) and the Food and Drug

Earlier this week, the U.S. Food and Drug Administration (FDA) unveiled its much-anticipated final guidance on predetermined change control plans (PCCPs) for devices incorporating artificial intelligence and machine learning (AI/ML) software. This guidance signifies a significant milestone in the

Clinical research has long been a cornerstone of advancing medical science, characterized by a significant historical trajectory. Over decades, its momentum has increased with the advent of new knowledge and technologies, enabling the development of improved therapeutics. From the discoveries in

In light of potential regulatory relaxations under the Trump administration, South Korean pharmaceutical and biotech companies are eagerly eyeing the opportunities to secure FDA approvals for their innovative drugs. This ambitious pursuit has been catalyzed by the prospect of a more lenient