DDT Contacts and Submitting Procedures

New! Change in Process for Qualification of Drug Development Tools

The process for qualification of drug development tools is changing under new FD&C Act Section 507. FDA is posting information about these updates to the DDT submission processes.

Check for details, documents and information consistent with new section 507(c).


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: 06/08/2017
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