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  1. Development & Approval Process (Drugs)

Drug Development Tool Qualification Programs Contacts

Drug Development Tool Qualification Programs Contacts

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 Models
Animal Model Qualification Program
Email: AnimalModelQualification@fda.hhs.gov

Biomarkers2
CDER-Biomarker Qualification Program
Email: CDER-BiomarkerQualificationProgram@fda.hhs.gov

Clinical Outcome Assessments
Clinical Outcome Assessments Staff
Email: COADDTQualification@fda.hhs.gov

 

Center for Biologics Evaluation and Research

For all qualification program teams (animal models, biomarkers, and COA)

Email: CBER-DDTQualificationProgram@fda.hhs.gov.
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.