Biomarker Qualification Contacts and Submitting Procedures

Biomarker Qualification Contacts

Email: CDER-BiomarkerQualificationProgram@fda.hhs.gov
Phone: 301-796-2600

Biomarker Qualification Submitting Procedures

Electronic Submissions only:

All Biomarker qualification correspondence and documents (Letter of Intent, Joint FDA/ EMA Letter of Intent (LOI) Submissions for Biomarker and Clinical Outcome Assessment Qualification Programs, Initial Biomarker Qualification Briefing Package, Briefing Documents, Full Qualification Package),  must be transferred to an optical disc storage media format (i.e., CD or DVD) and accompanied by a paper copy Drug Development Tool (DDT) Cover Letter.  A copy of the Cover letter should also be included in the electronic media.

Email Alert for Correspondence and Submissions 

Please email CDER-BiomarkerQualificationProgram@fda.hhs.gov once a submission or correspondence has been sent.

Additional Instructions for Initial Briefing Package Submissions

Please email CDER-BiomarkerQualficationProgram@fda.hhs.gov 30 days in advance of planned submission date so that internal meetings can be planned and scheduled.

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: 01/24/2017
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