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FDA Reassures Industry on Use of Quality Metrics
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U.S. Opposes Waiver of Drug Patent Rules in Least Developed Countries
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Data Integrity Cited in All Eight FDA Warnings to API Makers in FY15
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FDA: Focus of Quality Metrics is Surveillance, Not Enforcement
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Mastering the FDA's Import Rules
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CMC Submissions May Be Putting Your Data at Risk
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Alabama Compounder Recalls All Sterile Drug Products
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FDA Issues More Warnings, Import Alerts to Indian Drugmakers
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Final Guidance Allows FDA to Destroy Some Drug Imports
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Firms Must Notify FDA of Suspected Counterfeits in 24 Hours
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ICH Finalizes Guidance on Elemental Impurities
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Merck, BD Facing Issues Over Drug Container Closures
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