Rx/Dx combo product meeting
This article was originally published in The Gray Sheet
Executive Summary
July 29 workshop in Arlington, Va. will provide FDA with diagnostic and drug industry feedback on recent pharmacogenomics regulatory experiences, as agency drafts guidance on co-development of drug/ diagnostic products. Issues to be considered at the FDA/Drug Information Association-sponsored meeting include clinical trial design, clinical utility of PGx diagnostic products and analytical validation of those diagnostics, according to FDA...