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FDA Accepts Sandoz’s Application for Biosimilar of Amgen’s Enbrel
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FDA’s Generics Backlog Is Hurting Competition, Lawmaker Says
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Mylan Launches Generic Invega Tablets
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EU Drugmakers Call for Incentives to Spur Biosimilars Competition
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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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FDA Begins Search to Replace Retiring CBER Director
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FDA Releases Final Guidance on Controlled Correspondence
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United Therapeutics Settles Sandoz Patent Dispute Over Remodulin
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FDA’s Team-Based Inspection Starting to Take Shape
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Initial NIPP Inspections Draw High Praise From FDA Staff
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Product Hopping May Violate Antitrust Laws, FTC Says
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