FDA Updates Breakthrough Devices Program Information and 2026 Designation Data
FDA’s Breakthrough Devices Program provides expedited interaction and prioritized review for eligible medical devices intended to treat or diagnose life-threatening or irreversibly debilitating diseases or conditions.
Health Canada Ends Reconsideration Path for Priority Review and NOC/c Decisions
Health Canada eliminates reconsideration requests for priority review and NOC/c decisions from April 2026. Key regulatory impacts for drug sponsors explained.