FDA: Qualification Process for Drug Development Tools

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. Qualification is a conclusion that within the stated context of use, the results of assessment with a DDT can be relied upon to have a specific interpretation and application in drug development and regulatory decision-making.