Multistakeholder Approaches to Optimize Oncology Market Access Strategy
Effective oncology market access strategy has become markedly more complex as geopolitical pressures reshape how innovative cancer therapies reach patients, as made clear in Iroda Jurabekova’s pharma summit presentation. Determining whethe...
Advancing Real-World Evidence AI in Medicines Regulation
The adoption of Real-World Evidence AI is reshaping how the European Medicines Agency evaluates medicines, according to the European Medicines Agency’s annual report. By moving these technologies from pilot project...
Strengthening Medicine Shortages Management for Enhanced Availability and Access
The European Medicines Agency made medicine shortages management a foundational policy objective in 2025, as highlighted in its annual reports and work programmes. By advancing coordinated shortages oversight and d...
AI Healthcare Liability and Ethical Accountability in Clinical Practice
AI Healthcare Liability has surged to the forefront of European healthcare as powerful clinical algorithms outpace existing legal structures. A joint opinion by the national bio...
Regulatory Expansion of OTC Glucose Monitoring for Children
The FDA has cleared the first over-the-counter continuous glucose monitor for children as young as two who do not use insulin, establishing OTC Glucose Monitoring Children as a practical new option for families. This
FDA Medical Device Exemptions for Low-Risk Unclassified Products
The FDA Medical Device Exemptions target specific unclassified preamendment devices that present minimal risk to patients. By exercising enforcement discretion, the agency no longer expects manufacturers to submit 510(k) premarket notification applications for these products until a formal exempt...
