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Extension of Comment Period On Amending ANDA, 505(b)(2)
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HHS to Investigate Recent Rise in Generics Prices
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Court Upholds Most of $76M Award In Apotex-AstraZeneca Patent Case
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EU Regulator Stands Firm on PK Studies for Insulin Biosimilars
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Obama Calls for Larger Industry Role in Antibiotic Resistance Fight
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German Watchdog Criticizes EMA’s 'Commercially Confidential’ Definition
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European Regulators Release Final Guidance on Insulin Biosimilars
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Sponsors Must Report All Deaths in Trials, India Guidance Says
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NICE Updates Process for Reviewing Biosimilars
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EFPIA Proposes Process to Facilitate Early Resolution of Patent Disputes
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Tufts Pegs CROs, Cancer, Trial Design Hottest Trends of 2015
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FDA Outlines Clinical Pharmacology Considerations in Pediatric Trials
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