ARTICLES BY MARK DURIVAGE
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![FDA headquarter iStock-1213293784]( "FDA Seeks Comment On Circumstances For Delaying, Denying, Limiting, Or Refusing An Inspection")
FDA Seeks Comment On Circumstances For Delaying, Denying, Limiting, Or Refusing An Inspection1/9/2023The FDA has released for public comment a proposed draft guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection Revision 1. The guidance shares examples of reasonable and unreasonable circumstances. Submit public comments by February 14, 2023.
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![FDA headquarter iStock-1213293784]( "FDA Seeks Comment On Conducting Remote Regulatory Assessments")
FDA Seeks Comment On Conducting Remote Regulatory Assessments8/11/2022The FDA believes the use of both voluntary and mandatory remote regulatory assessments (RRAs) for all types of FDA-regulated products is in the interest of public health. The document describes the difference between voluntary and mandatory RRAs and shares information about the RRA report. Public comment ends on Sept. 30, 2022.
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![FDA headquarter iStock-1213293784]( "FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products")
FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products7/14/2021At the end of June, the FDA released a new guidance to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application. This article summarizes the guidance.
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.