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):
CDER-Biomarker Qualification Program
Phone: (301) 796-2600
Refer to the Biomarker Qualification Contacts and Submitting Procedures web page for additional submission information specific to the Biomarker Qualification Program.
Clinical Outcome Assessments
Study Endpoints and Labeling Development (SEALD) - Study Endpoints Team
Animal Model Qualification Program Team
The submission process
Electronic Submissions only: All DDT qualification correspondence and documents must be transferred to an optical disc storage media format (i.e., CD or DVD) and accompanied by a paper copy of the Drug Development Tool (DDT) Cover letter (PDF). A copy of the Cover letter should also be included in the electronic media.
Submission Mailing Address: The paper copy DDT Cover letter and electronic media should be mailed to:
CDER Central Document Room
5901-B Ammendale Road
Beltsville, MD 20705-1266