FDA has released guidance on the process for qualifying drug development tools (DDTs) intended for potential use, over time, in multiple drug development programs. Guidance for Industry and FDA Staff, Qualification Process for Drug Development Tools defines DDTs as methods, materials, or measures that aid drug development that include, but are not limited to, biomarkers, clinical outcome assessments (COAs), and animal models for drug development under the Animal Rule.
FDA provides a framework for interactions between the Center for Drug Evaluation and Research (CDER) and the submitter of the DDT for qualification. The guidance outlines the kinds of data that should be submitted to support qualification of a DDT. It also creates a process for CDER’s formal review of the data.
The guidance states, “Qualification does not pertain to the process for review of DDTs that are submitted as part of regulatory applications for a specific drug development program. Furthermore, this guidance does not address the evidentiary standards or performance requirements needed for purposes of qualification.”
FDA also released an attachment to the guidance on the qualification of exacerbations of chronic pulmonary disease tool.