The Drug1 Development Tool (DDT) Qualification Programs engage with requestors from industry, academia, vendors (contract research organizations), government agencies, and foundations. Any individual or group can contact FDA for consideration and discussion of potential DDTs and the value they could bring to drug development.
Each DDT program has its own point of contact. For questions related to a specific DDT qualification program, please refer to the appropriate contact below.
Center for Drug Evaluation and Research
Animal Model Qualification Program
Clinical Outcome Assessments
Clinical Outcome Assessments Staff
Center for Biologics Evaluation and Research
For all qualification program teams (animal models, biomarkers, and COA)
In the subject line, please indicate which program you are interested in contacting: animal studies, biomarkers, or clinical outcome measures. For inquiries only, do not send submissions to email address.
1 The term drug refers to both human drugs and biological products unless otherwise specified.
2 A biomarker can be a single concept or a panel of multiple concepts.