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Discover Define-XML

PharmaSUG 2014 – Paper DS01 Discover Define-XML Mark Wheeldon and Kevin Burges, Formedix, Burlington, MA   ABSTRACT Previously, Define.pdf was used as a submission deliverable to enable FDA reviewers to understand the content of submitted

FDA Study Data Exchange Standards

THE CASE FOR CDISC ADOPTION: SOLUTIONS FOR STUDY DATA EXCHANGE STANDARDS IN CLINICAL TRIALS KEVIN BURGES TECHNICAL STANDARDS DIRECTOR, FORMEDIX   ABSTRACT The Food and Drug Administration (FDA) recently announced a meeting, “Regulatory New Drug