Drugs

Drug Development Tool Submissions Process

Below are instructions on how to submit regulatory documents (e.g., Letter of Intent, Qualification Plan, Full Qualification Package) to a DDT Qualification Program. Please note, there are no fees associated with the DDT Qualification Programs. Multiple DDTs should be submitted as separate submissions even if they are related.

We are currently updating the formal submissions process. Please continue checking this webpage for updates and changes. If you have any questions, please contact the appropriate DDT Qualification Program.

Electronic Submissions only: Please note the DDT Qualification Programs only accepts electronic submissions. 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 (under development).

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: 10/17/2018
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