Drug Development Tools | DDTs

DDTs are methods, materials, or measures that can potentially facilitate drug development. FDA established qualification programs to support DDT development.

General DDT and Contact Information

• Drug Development Tool Qualification Programs
• Summary Metrics of Drug Development Tool Qualification Projects Submitted to FDA
• Drug Development Tool Qualification Programs Contacts

DDT Qualification and Submission Process

• Drug Development Tool Qualification Process
• Drug Development Tool Qualification Process: Transparency Provisions
• Drug Development Tool Submissions Process

DDT Qualification Programs

• Animal Model Qualification Program
• Biomarker Qualification Program
• Clinical Outcome Assessments (COA) Qualification Program

DDT Resources

• Additional Drug Development Tool Resources