ABSTRACT
It has been more than 10 years since the FDA released its initial report on the “Challenge and Opportunity on the Critical Path to New Medical Products” (2004). The report included an extensive description of the critical need for drug development tools (Link to FDA report, 2004), including biological markers (biomarkers). In 2014, the FDA published a guidance document that described the process for qualifying these drug development tools in order to accelerate drug approvals. They also directly encouraged the formation of collaborative groups that could share the burden of biomarker development and stated that several consortia had previously shown the usefulness of this approach.
