The FDA has issued final guidance on the process for qualifying drug development tools.
The guidance describes the process for qualifying tools intended for potential use, in multiple drug development programs: methods, materials, or measures that aid drug development. The scope of the guidance includes, but is not limited to, biomarkers, clinical outcome assessments (COAs), and animal models for drug development.
The guidance provides a framework for interactions between the Center for Drug Evaluation and Research (CDER) and the entity proposing the DDT for qualification. It also explains the kinds of data that should be submitted to support qualification of a DDT and creates a mechanism for CDER’s formal review of the data to ultimately qualify the DDT.