Biomarker Qualification FAQ
Who, within FDA, evaluates biomarker data and recommends for or against qualification?
The initial data evaluation and qualification recommendation is made by the Biomarker Qualification Review Team (BQRT). This team is comprised of primary reviewers drawn from offices within CDER (and others in FDA as appropriate). The team will have representation from each of the disciplines necessary (as appropriate) to ensure adequate breadth of expertise.
What if CDER declines the LOI request?
If CDER declines the DDT request, a communication to the submitter will include the
reasons for the decision, and any advice on alternative paths for DDT development and
Can an imaging biomarker be qualified if the imaging agent used in biomarker development is unapproved?
In some cases, measurement of an imaging biomarker will require administration of an imaging agent drug. Qualification of the biomarker is distinct from marketing approval of the imaging agent drug. When the imaging agent is already approved and the biomarker context of use falls within the imaging agent’s approved indication, biomarker development can proceed without need of an IND. Imaging biomarker contexts of use should be carefully planned and described to so that, if qualified, no unapproved indication for use of the imaging agent is implied or can be inferred. When the imaging agent is not already approved, the clinical studies supporting biomarker development will need to be performed under an IND.