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  6. Biomarker Qualification Program Submission Frequently Asked Questions
  1. CDER Biomarker Qualification Program

Biomarker Qualification Program Submission Frequently Asked Questions

Below you will find frequently asked questions about the Biomarker Qualification Program (BQP).  Additional topics and information are available on the General Biomarker Information section of the website.

Prior to Submitting

 About Submissions

Prior to Submitting

When am I ready to begin the submission process?
You are ready to begin the qualification process with an LOI  when you have a clear understanding of what drug development need the novel biomarker intends to address, the Context of Use (COU) for the biomarker development effort, potential benefits and risks associated with this COU, what existing evidence supports the COU, as well as the scientific knowledge gaps and how they will be addressed.  In addition, you should be able to describe the measurement method, demonstrate the feasibility of and risks associated with measurement, and the relationship of the measurement to the disease/population/drug development area. Additional considerations may include;

  • Biological rationale for use of the biomarker (if known)
  • Assay considerations (analytical validation and understanding of potential sources of variability in the measurement)
  • Characterization of the relationship between the biomarker, the outcome of interest, and the treatment (where applicable) required for the proposed COU (clinical validation and understanding the potential sources of bias)
  • Type of data available to assess the strength of association of the biomarker with its proposed outcome: retrospective or prospective, registry data, and/or randomized controlled trial (RCT) data
  • Reproducibility of this supportive data
  • Use of appropriate, specified statistical methods to demonstrate the hypothesized relationships for the COU

Is there an application fee to qualify a biomarker?
No. There are no fees for qualifying a biomarker.

Can multiple biomarkers be submitted as a single submission?
A “composite biomarker” that is made up of several individual biomarkers combined in a stated algorithm with one COU can be submitted as a single submission. Multiple biomarkers with independent COUs should be submitted as separate submissions.

About Submissions

What information will be made public?
The 21st Century Cures Act includes transparency provisions regarding summary level information submitted to FDA as well as FDA’s decision including recommendations for further biomarker development. 

Can a COU be revised during the qualification process?
Yes. A COU may be revised during the qualification process. The biomarker description, category and COU help to establish what types of supporting evidence are needed to qualify the biomarker and proposed COU. A qualified COU may evolve over time as more data are accumulated.

What Do You Need to Consider When Qualifying a Biomarker?

Who participates in the Biomarker Qualification Review?
Biomarker Qualification Review is performed by reviewers identified as subject matter experts from offices within CDER (and other Centers in FDA as appropriate) with oversight by FDA senior leadership. The reviewers will have representation from each of the disciplines necessary (as appropriate) to ensure adequate breadth of expertise.

Where do I find examples of biomarker submissions to the Biomarker Qualification Program?
Please see the List of Biomarker Submissions  on FDA’s website.

Can published literature be used to support biomarker qualification?
Yes. Published literature can be used to support the qualification of a biomarker. Depending on the COU, this information may be sufficient but many times additional supportive information (e.g., analytical and clinical validation data) may be needed.

Who do I contact for more information?
For more information about the CDER Biomarker Qualification Program, please contact 
CDER-BiomarkerQualificationProgram@fda.hhs.gov.

Important Information for Requestors

Contact us at: CDER-BiomarkerQualificationProgram@fda.hhs.gov

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