DDT Contacts and Submission Process
For questions related to the DDT qualification programs, please refer to the following contact information that is specific to each DDT type (i.e., biomarkers, clinical outcome assessments and animal models):
Phone: (301) 796-7495
Clinical Outcome Assessments
Study Endpoints and Labeling Development (SEALD)—Study Endpoints Team
Phone: (301) 796-0900
Animal Model Qualification Program Team
The submission process
All submissions (regardless of DDT type) should be handled as described in the DDT guidance (insert link).
CDER Central Document Room
5901-B Ammendale Road
Beltsville, MD 20705-1266
Attention: DDT QUALIFICATION SUBMISSION
(Specify DDT Program – BIOMARKER, CLINICAL OUTCOME ASSESSMENT, or ANIMAL MODEL)
- All submissions under these DDT programs must be submitted on either a compact disc (CD) or optical disc storage media format (e.g., DVD).
- All DDT submissions under these DDT programs must be accompanied by a Cover Letter (see individual program pages for specific templates). There should be a paper copy of the Cover Letter submitted with the electronic submission and a scanned copy of the Cover Letter included in the electronic media.