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

Area of Science:

• Digital Medicine
• Regulatory Science
• Pharmaceutical Informatics

Background:

• Drug therapy is evolving from static information delivery to dynamic, software-driven patient care.
• The U.S. Food and Drug Administration (FDA) introduced the Prescription Drug Use-Related Software (PDURS) framework in September 2023.
• PDURS establishes regulatory guidelines for software outputs linked to prescription drug use, integrating them into drug labeling.

Purpose of the Study:

• To systematically review the core concepts and technical features of the PDURS framework.
• To examine the potential impacts of PDURS on personalized medicine, drug safety, and pharmaceutical innovation.
• To analyze the implications of PDURS for medication use monitoring and information transparency.

Main Methods:

• Systematic review of the PDURS framework.
• Analysis of PDURS's impact on digital medicine paradigms.
• Examination of regulatory and pharmaceutical industry implications.

Main Results:

• PDURS enables software-generated, patient-facing outputs subject to drug labeling requirements.
• The framework supports individualized medication decisions, improves adverse event monitoring, and facilitates real-world data generation.
• PDURS significantly impacts pharmaceutical R&D, clinical trials, regulatory compliance, and drug value creation.

Conclusions:

• PDURS is a foundational infrastructure for digital medicine, promoting patient-centered care and precision medication.
• Strengthened international collaboration and communication are crucial for realizing PDURS's full potential.
• The framework necessitates new approaches in medical education and global drug regulatory coordination.