The Food and Drug Administration (FDA) has issued for public comment a draft guidance entitled “Qualification Process for Drug Development Tools.” The document is intended to describe the qualification process for drug development tools (DDTs) (e.g., biomarkers, patient reported outcomes) intended for potential use across multiple drug development programs. FDA proposes a mechanism for formal review by FDA to qualify the DDT, and a framework for interactions with the agency to better identify the data needed to support qualification of a DDT. FDA is accepting public comments until January 24, 2011.