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FDA Announces Quality Metrics Details; Drugmakers to Focus on 10 Data Points
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Will You Be Ready for Your Next GMP Inspection?
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Compounders Press FDA For Revised MOU
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FDA: Take Lifecycle Approach to Analytical Methods Validation
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EMA Outlines Requirements for Manufacturing Finished Dosage Forms
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New Excipient GMPs in EU Take Effect in March
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Seven More Compounders in Trouble Over Sterility Issues
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FDA Requires Six-Month Notice for Potential Manufacturing Stoppages
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Expert Advice on Getting CAPA Right
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Indian Manufacturers See More Compliance Woes
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Hospira, Teva, Mylan and Baxter Recalls Pile Up
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Disconnect Between Management, QCU Possible Source of Warning Letters
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