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Life Sciences Decoded

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FDA dishes out major regulatory challenges for food industry in 2016

January 25, 2016
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As the FDA continues to intensify its enforcement over its regulated industries, food companies should prepare now to manage their risk by developing and implementing a set of strict compliance programs to avoid enforcement action. READ MORE

New FDA rule places increased food safety responsibility on importers, foreign suppliers

November 30, 2015
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“Foreign Supplier Verification Programs for Importers of Food for Humans and Animals” is the most recent Rule promulgated under the Food Safety and Modernization Act and places new responsibility on industry members to ensure that foreign suppliers follow the FDA’s HARPC requirements, that compliance is documented, and that importers include this new supply chain verification system in their HARPC food safety plans. READ MORE

Long-awaited overhaul of FDA food safety rules arrives – Part II: A roadmap for food manufacturers on FDA’s changes to cGMPs

September 29, 2015
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With the passage of the Food Safety and Modernization Act (FSMA), the FDA has created a new and updated set of cGMPs in conjunction with the new Hazard Analysis and Risk-Based Preventative Controls (HARPC) program to correct this lag. READ MORE

Long-awaited overhaul of FDA food safety rules arrives – Part I: Introducing HARPC, changes to cGMP

September 22, 2015
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Since the passage of the Food Safety Modernization Act in 2011, the FDA has promulgated proposed rules that overhaul the old Good Manufacturing Practice (cGMP) rule and create new Hazard Analysis and Risk-Based Preventative Controls (HARPC) for certain food. READ MORE