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Experts: Data from Women Key to Successful Trials
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EMA Clarifies Clinical Requirements for Fixed-Dose Combinations
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Pediatric Extrapolation Guidance Applies to New, Existing Devices
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FDA Encourages Use of Patient Preferences in Device Submissions
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EMA Clarifies Clinical Requirements for Fixed-Dose Combination Drugs
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Clot Treatment Trials Should Be Tailored to Type of Clot: EMA
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Study: Head-to-Head Trial Results Suggest Conflict of Interest
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EMA Stands Firm on PK Studies for Insulin Biosimilars
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FDA Clarifies Endpoints in NSCLC Clinical Trials
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Growth in Overseas Device Trials Fuels FDA Draft Guidance
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European Regulators Release Final Guidance on Insulin Biosimilars
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Medidata: mHealth Can Help in Tracking Patient Outcomes
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