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Details Emerge on Phase Two of ISPE’s Quality Metrics Pilot Program
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ISPE: Industrywide Quality Metrics Program Doable, but Costly
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Health Canada Launches Online Inspections Database
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Particulates Force Teva to Recall Injectable
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Wockhardt’s Woes Continue With Blood Pressure Tablet Recall
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CXL-USA Warned for Failure to Review Trial-Related Records
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Excipient GMP Standard Brings New Risk-Assessment Requirements
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Akorn Recalls Thousands of Units of Antibacterial Due to Dissolution Issues
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FDA Clarifies When to Report Postapproval CMC Changes
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Gilead Sciences Lands Form 483 Due to Production Issues
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Dr. Reddy’s Facility Hit With Eight-Observation Form 483
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FDA Bioresearch Monitoring Inspections Increase in 2014
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