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U.S. Department of Health and Human Services

Drugs

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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.

 

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