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Adding Pediatric Studies to New Drug Development: A Guide to US and EU Rules
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Social Media Accountability for Drug and Devicemakers
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Navigating HCT/P Regulations: Risks and Opportunities for Drug and Device Manufacturers
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Pharma Strategies in Latin America: Keys to Success
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Achieving ANDA Success: Working with the FDA to Win First-Cycle Approval
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Off-Label Drug Promotion after Amarin: What Does the FDA Settlement Mean?
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Pharmacovigilance in the European Union: A Guide to New Directives
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Report Finds Recommendation Rates From FDA AdComms Fluctuate Wildly
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FDA Takes First Step Toward Revoking Armepharm’s ANDA
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FDA Catches Flak for Pushing Back Final Rule on Generic Drug Labeling Changes Once Again
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FDA Establishes Meetings Framework for Biosimilars Application Holders
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FTC Says Pay-for-Delay Violations Not Contingent on Regulatory Action
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