Biomarker Qualification Submissions
Electronic Submissions only: All Biomarker qualification correspondence and documents must be transferred to either a compact disc (CD) or optical disc storage media format (e.g., DVD) and accompanied by a paper copy DDT Cover Letter (see Cover Letter template). A copy of the Cover letter should also be included in the electronic media.
All submissions (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.