ARTICLES BY MARK DURIVAGE

  • FDA headquarter iStock-1213293784
    FDA Releases Pre-Launch Activities Importation Requests (PLAIR) Guidance
    5/24/2022

    The FDA has finalized the draft guidance describing the policy regarding requests for the importation of unapproved finished dosage form drug products by applicants preparing products for U.S. market launch based on anticipated approval of a pending NDA, ANDA, BLA, or combination product assigned to CDER.

  • Close up on eyes GettyImages-1207244495
    FDA Proposes Inspection Of Injectable Products For Visible Particulates
    2/1/2022

    FDA and CDER have released a draft guidance addressing the development and implementation of a holistic, risk-based approach to visible particulate control incorporating product development, manufacturing controls, visual inspection, particulate identification, investigation, and corrective actions. The public comment period ends Feb. 15, 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.