Exploring the Current Regulatory Framework for Approvals of CDx by the FDA

Time: 8:00 am
day: Day 1 AM


  • Providing an overview of successful submissions to the FDA, the typical challenges encountered, how to overcome and how to increase success 
  • Discussing novel approvals, new guidelines and devices that were recently approved that have set a new regulatory precedent
  • Looking at what's on the horizon, the emerging trends and cutting-edge technologies and biomarkers