DDT Contacts and Submitting Procedures


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
Email: CDER-BiomarkerQualificationProgram@fda.hhs.gov
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

Clinical Outcome Assessments Staff
Phone: 301-796-0900  

Animal Models

Animal Model Qualification Program Team
Email:  AnimalModelQualification@fda.hhs.gov
Phone:  301-796-2210

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 

Page Last Updated: 10/07/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English