ARTICLES BY PETER H. CALCOTT
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![FDA headquarter iStock-1213293784]( "FDA Issues New Guidance: Nonclinical Safety Assessment Of Oligonucleotide-Based Therapeutics")
FDA Issues New Guidance: Nonclinical Safety Assessment Of Oligonucleotide-Based Therapeutics12/11/2024FDA's CDER recently issued a draft guidance: Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics. This article provides a summary and analysis. The public comment period ends January 14, 2025.
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![FDA headquarter iStock-1213293784]( "FDA Issues Draft Guidance On Remote Interactive Evaluations Of Drug Manufacturing And Bioresearch Monitoring Facilities")
FDA Issues Draft Guidance On Remote Interactive Evaluations Of Drug Manufacturing And Bioresearch Monitoring Facilities12/5/2023In October , FDA issued a draft guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities: Guidance for Industry, which describes how the FDA is operating their remote evaluations program, the logistics of its implementation, and what they expect of industry. The public comment period ends December 26.
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![FDA headquarter iStock-1213293784]( "FDA Introduces Quality Management Maturity Program")
FDA Introduces Quality Management Maturity Program9/26/2023The FDA program described in a new document, CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development, is a next logical step to drive better quality, more predictable outcomes, and supply chain assurance.
Peter H. Calcott
LinkedIn
Calcott Consulting LLC, is focused on delivering solutions to pharmaceutical and biotechnology companies in the areas of corporate strategy, supply chain, quality, clinical development, regulatory affairs, corporate compliance, and enterprise e-solutions. He is also an academic program developer for the University of California, Berkeley in biotechnology and pharmaceutics postgraduate programs. Previously, he was executive VP at PDL BioPharma, where he was responsible for development and implementation of quality and compliance strategy across the corporation. He has held numerous positions in quality and compliance, research and development, regulatory affairs, process development and manufacturing at pharmaceutical companies including Chiron, Immunex, SmithKline Beecham, and Bayer. He has successfully licensed products in the biologics, drugs, and device sectors on all six continents. Dr. Calcott holds a doctorate in microbial physiology and biochemistry from the University of Sussex in England.