Biomarker Qualification Contacts
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.