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Interchangeability Guideline May Come in Early 2016, Expert Says
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Japan’s New Fast Track Pathway for Drugmakers
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FDA Reopens Comment Period for CMC Draft Guidance
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FDA Allows Draft Labeling for ANDA Approvals
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EU Drugmakers Call for Incentives to Spur Biosimilars Competition
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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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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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PTAB Negates Novartis Patent on MS Treatment Gilenya
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FDA Launches Search to Replace Retiring CBER Director Midthun
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