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Drug Approval Backlog Nears 19,000 in China
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Groups Use Neupogen Biosimilar Vote to Highlight Outstanding Issues
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Gilead Denied Sovaldi Patents in India, Paving Way for Generic Competition
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Judge Sides With FDA Over Colchicine 505(b)(2) Approval
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2015 Guidance Expected on Social Media, Biosimilars and Quality Metrics
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EMA Adopts Final Guideline on Biosimilarity Clinical Considerations
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FDA Panel Signs Off on Sandoz’s Biosimilar Application on Neupogen
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New Quality Office Among Top 2015 CDER Priorities
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FDA Quality Metrics Program Delayed, Extended to Biologic Products
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Drugmakers Win Four-Month Reprieve from Product Tracing Requirement
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Industry Wants More Drugs Eligible for ‘First Generic’ Status
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Industry Expresses Trepidations With Proposed Pill Change Survey
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