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FDA Updates Guide on Clinical Study Data eSubmissions
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Brazil Clarifies Rules on Public-Private Product Development Partnerships
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EMA Adaptive Pathway Pilot Underway With Initial Group of Six Medicines
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2014: A Year Focused on Transparency, Drug Safety and a Crisis in West Africa
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Q&A Guidance Clarifies Criteria for EMA Adaptive Licensing Pilot
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Drugmakers’ Guide to Global Quality API Manufacturing
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Expediting the FDA Generic Drug Approval Process
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Japan’s PMDA Clarifies Requirements for Companion Diagnostic PMAs
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Australian Details Requirements for Biopharmaceutic Studies
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HHS Panel: Sites Should Provide Trial Results to Patients
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Japan Clarifies Requirements for Companion Diagnostics
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HHS Panel Discusses Pros/Cons of Big Data in Clinical Research
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