The evidentiary framework described in this guidance identifies the recommended components  of a biomarker development program, including determining the type and level of evidence  sufficient to support qualification, and addresses how these components interrelate to inform the  evidentiary framework. This evidentiary framework is broadly applicable to all biomarker  qualification submissions, regardless of the type of biomarker or context of use (COU).

Qualification of a biomarker is a determination that within the stated COU, the biomarker can be  relied on to have a specific interpretation and application in drug development and regulatory review. Thus, a qualified biomarker can be used across multiple drug development programs  under the COU for which it was qualified. Requests for qualification of a biomarker should address the evidentiary framework discussed in this document


Biomarker Qualification: Evidentiary Framework Guidance for Industry and FDA Staff