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International Harmonization is Goal of Quality Metrics: Woodcock
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WHO Flags India’s Svizera Labs For Data Integrity, GMP Issues
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EMA: QMS, AE Reporting Top 2014 Postmarketing Inspection Deviations
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Will Your Quality System Meet FDA’s Expectations?
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FDA Warns Mylan Over GMP Issues at Three India Sites
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Seattle Genetics’ Form 483 Focuses On Recently Approved Cancer Drug
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Caterpillar Lands Pernix 483
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FDA Dings Pfizer China Facility Over Sample Retesting, cGMP Deviations
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Genzyme Hit With 16-Observation 483 Over Lapses in Quality Controls
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Novartis Lands 11-Item 483 for Flu Vaccine Deficiencies
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Expert Advice on Addressing Data Integrity Issues
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FDA Questioned by House Committee Over NIH Lapses
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