From policy to practice: Evaluating the global implications of the FDA’s PDURS framework

With the rapid development of digital medicine, drug therapy is gradually shifting from a traditional model centered on static information delivery to a dynamic management paradigm driven by software, data, and patient-centered care. In September 2023, the U.S. Food and Drug Administration (FDA) released the Prescription Drug Use-Related Software (PDURS) framework, providing a regulatory foundation for the regulation of software-generated end-user outputs that are directly related to prescription drug use and treated as part of drug labeling. From a digital medicine perspective, this review systematically summarizes the core concepts and technical features of the PDURS framework and examines its potential impacts on personalized medicine, drug safety, information transparency, medication use monitoring, and pharmaceutical innovation. The findings suggest that by transforming drug-use information into software-generated, patient-facing outputs that are subject to drug labeling requirements, PDURS supports patient-centered individualized medication decision-making, enhances adverse event monitoring and risk management, and facilitates the continuous generation and application of real-world data. Furthermore, the PDURS framework has profound implications for pharmaceutical companies, influencing research and development models, clinical trial efficiency, regulatory compliance, industry collaboration, and drug value creation, while also posing new requirements for medical education and global drug regulatory coordination. This review further highlights that strengthened international communication and institutional collaboration are essential to fully realize the potential of PDURS as a foundational infrastructure for digital medicine and to promote the healthy development of global drug digitalization and precision medication.