CRDSA roundtable analysis and recommendations from the public feedback on the FDA draft external controls guidance

Report from the CRDSA roundtable on the public comment to the FDA draft external controls guidance outlines key regulatory challenges and proposes next steps. The Clinical Research Data Sharing Alliance (CRDSA) has recently issued a report developed from its July roundtable discussion of the public feedback received on the US FDA draft guidance on externally controlled trials. The report FDA Draft External Controls Guidance: Situation Analysis and Recommendations provides an overview of the roundtable discussion, outlines key regulatory challenges identified from the public feedback, and suggests recommendations for next steps developed by consensus following the roundtable. Here we summarize the...