ARTICLES BY MARK DURIVAGE

  • FDA headquarter iStock-1213293784
    FDA Seeks Comment On Fit-For-Purpose COAs Guidance
    7/14/2022

    On June 29, the FDA released the new guidance, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments. This article sums up the guidance and explains the four types of COAs that the FDA prefers (PROs, ObsROs, ClinROs, and PerfOs). Submit comments to the FDA by September 28, 2022.

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Mark Durivage

Mark Allen Durivage is the managing principal consultant at Quality Systems Compliance LLC and an author of several quality-related books. He earned a BAS in computer aided machining from Siena Heights University and an MS in quality management from Eastern Michigan University. Durivage is an ASQ Fellow and holds several ASQ certifications, including CQM/OE, CRE, CQE, CQA, CHA, CBA, CPGP, CSQP, and CSSBB. He also is a Certified Tissue Bank Specialist (CTBS) and holds a Global Regulatory Affairs Certification (RAC). Durivage resides in Lambertville, Michigan. Please feel free to email him at mark.durivage@qscompliance.com with any questions or comments, and connect with him on LinkedIn.