Resources for Biomarker Requestors
Get Started With Your Submission
How to engage with the Biomarker Qualification Program (BQP)
If you have questions please contact BQP at: CDER-BiomarkerQualificationProgram@fda.hhs.gov
Biomarker qualification is a process involving three stages that provide increasing levels of detail for the development of a biomarker for its proposed context of use (COU). Here we provide resources to assist requestors in making complete submissions to the CDER Biomarker Qualification Program.
See 21st Century Cures Act: Qualification of DDT for a description of how the process for qualification of drug development tools is changing under new FD&C Act Section 507.
Qualification Stages & Submissions
|1||Letter of Intent (LOI)|
|2||Qualification Plan (QP)|
|3||Full Qualification Package (FQP)
|All Stages||BQP Cover Letter|
Biomarker Qualification Submitting Procedures
All Biomarker Qualification submissions must be transferred to an optical disc storage media format (i.e., CD or DVD) containing the submission and digital Cover Letter accompanied by a paper copy of the Cover Letter.
Email Alert for Correspondence and Submissions
Please notify us via email CDER-BiomarkerQualificationProgram@fda.hhs.gov once sending a submission.
Submission Mailing Address
The paper copy Cover Letter and electronic media should be mailed to:
CDER Central Document Room
ATTN: Biomarker Qualification Program
5901-B Ammendale Road,
Beltsville, MD 20705-1266.
Important Information for Requestors
- About Biomarkers and Qualification
- More About Biomarkers & Qualification
- General Biomarker Information
- 21st Century Cures Act
- Context of Use (COU)
- Biomarker FAQs
- BEST—a biomarker glossary
- Biomarker Qualification Submissions
- List of Qualified Biomarkers
- Letter of Support