Navigating Companion Diagnostics (CDx): Development and Regulatory Pathways
The rapid evolution of personalized medicine underscores the growing importance of companion diagnostics (CDx), making it a pivotal area of focus for regulatory affairs executives in the IVD industry. Here, […]
Considerations for Companion Diagnostics: Lessons Learned and Key Takeaways from DIA 2024
The In Vitro Diagnostics Regulation (IVDR) took effect in May 2022 and has introduced substantial changes in the regulatory framework for in vitro diagnostic medical devices (IVDs) in Europe. IVD […]
