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Winning Device EU Marketing Approval: Seven Steps to Writing Clinical Evaluation Reports
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Navigating HCT/P Regulations: Risks and Opportunities for Drug and Device Manufacturers
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Obtaining Consent in International Clinical Research: Key Considerations
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CDRH Touts Downward Trend in Clinical Trial Approval Times
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Experts: Data from Women Key to Successful Trials
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Using ISO 11607 to Develop Risk-Based Device Packaging
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Most GCP Infractions Tied to Sponsors, CROs: EMA
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India Issues Ream of Clinical Trial Regulations at Year End
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Year in Review: Transparency Leads the Clinical Trial Conversation Again
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Device Software Safety Risks: Standards Lead to Closer FDA Scrutiny
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Japan’s PMDA Clarifies Requirements for Companion Diagnostic PMAs
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Final Guidance on Home-Use Device Design Stresses Usability Testing, Risk-Management
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