The US FDA issued draft guidance on the Qualification Process for Drug Development Tools.As per the document drug-development tools (DDTs) include biomarkers and patient-reported outcome instruments, among other things. The draft guidance also offers a mechanism for formal review by CDER to qualify the DDT.
“Qualification” means “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.”
In the draft guidance, FDA proposes stages for the qualification process, including consultation and advice with CDER (e.g., letter of intent, briefing, meeting, investigation), and review for the qualification decision. The agency intends to make public its information regarding qualified DDTs.