ARTICLES BY PETER H. CALCOTT
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![FDA Issues New Guidance - Calcott_450x300]( "Insights Into The FDA's Guidance On Managing Drug Supply")
Insights Into The FDA's Guidance On Managing Drug Supply7/3/2023This new guidance describes the scope to include both permanent discontinuances as well as temporary interruptions in the manufacture of drugs including biological products and blood and blood-derived products.
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![Quality-GettyImages-858867906]( "FDA Finds Drug Shortages Are Mostly Caused By Quality Issues")
FDA Finds Drug Shortages Are Mostly Caused By Quality Issues6/6/2022New FDA guidance on risk management plans (RMPs) to mitigate the potential for drug shortages recommends an RMP for drugs that treat rare diseases and conditions, drugs with no alternatives, sole source products, products with only one API or manufacturing site available, and drugs made in facilities where an Official Action Indicated has been issued.
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.