This guidance describes the qualification process for drug development tools (DDTs) intended for potential use, over time, in multiple drug development programs. DDTs include, but are not limited to, biomarkers and patient reported outcome (PRO) instruments. The guidance provides a framework for interactions between CDER and DDT submitters to identify data needed to support qualification of a DDT and creates a mechanism for formal review by CDER to qualify the DDT.
CDER has undertaken multiple initiatives to aid the development of new DDTs. Among these efforts is the development of a formal process, described in this guidance, that CDER will use in working with submitters of these tools to guide them as they refine the tools and rigorously evaluate them for use in the regulatory process.
If a DDT is qualified, analytically valid measurements of it can be relied upon to have a specific use and interpretable meaning in drug development. The qualification process is expected to expedite development of successful marketing applications. Once a DDT is qualified for a specific context of use, industry can use the DDT for the qualified purpose during drug development, and CDER reviewers can be confident in applying the DDT for the qualified use without the need to reconfirm the DDT's utility.
The guidance is not intended to discuss the review of DDTs that are submitted as part of regulatory applications for a specific drug development program. Furthermore, it does not address evidentiary standards or performance requirements needed for purposes of qualification.