Summary Metrics of Drug Development Tool Qualification Projects Submitted to FDA

This Table provides the current number of active CDER Drug Development Tool (DDT) Qualification projects overall and by Program (DDT- Animal Model Qualification Program, DDT- Biomarker Qualification Program, DDT- Clinical Outcomes Assessment [COA] Qualification Program). Numbers are also provided by stage (Initiation Stage, Consultation and Advice Stage, Review Stage and Qualified).