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CDSCO Clarifies Requirements for Clinical Trial Applications
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China Fines GlaxoSmithKline $490 Million for Bribery
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EU Drug Regulation Moves to Industry Directorate
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EMA’s Guideline on Carcinogenic Risk Evaluation Takes Effect in 2016
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Guidance Eases Reporting of Adverse Events in EU Clinical Trials
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Q&A Guidance Clarifies Criteria for EMA Adaptive Licensing Pilot
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Pan-European Verification System Will Combat Stolen Medicines
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European Biosimilars Makers Seek More Appropriate Labeling Format
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Canada Cracks Down on Generic Pay-for-Delay Agreements
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Drugmakers’ Guide to Global Quality API Manufacturing
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6 Steps to Managing Drug and Device Customer Complaints
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Quality Risk Management for Pharmaceuticals
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