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FDA and EMA Provide Details on Convergence
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Data Integrity Issues Fuel Rise In Critical Inspection Findings
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Guidance Targets Overfilling of Vials, Ampules
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OPQ Plans Team-Based Assessments As Part of Drug Review Process
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Health Canada Launches Online Inspections Database
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Excipient GMP Standard Brings New Risk-Assessment Requirements
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FDA Clarifies When to Report Postapproval CMC Changes
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FDA Bioresearch Monitoring Inspections Increase in 2014
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FDA to Fund Research on Further Use of Quality Metrics
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Woodcock: FDA Wants Mutual Inspection Program With Europe
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Industry Seeks Clarification on New EU GMP Mandates
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Aging Aseptic and Biologic Manufacturing Sites: Design and Renovation for Compliance
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