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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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IPEC-Americas Proposes Guidelines for Stability Studies of Excipients
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FDA Questioned by House Committee Over NIH Lapses
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Canada to Require Evidence of GMP Compliance for Foreign Buildings
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FDA Guidance Sets Dissolution Specifications for IR Drugs
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Drugmakers Seek Clarity on FDA’s CMC Draft Guidance
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FDA Finalizes Guidance on When to Register as a Drug Compounder
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Drug Compounders Seek Clarification on FDA’s AE Reporting Guidance
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FDA Provides Details on Compliance Priorities, New Inspection Protocol Program
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Industry Questions FDA Authority to Collect Quality Metrics
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