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Alcobra’s Fragile X Syndrome Drug Fails Phase 2 Trial
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FDA Adds Plasma Fibrinogen as Biomarker in COPD Trials
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FDA Releases Bioequivalence Guidance for 43 Drug Products
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EMA Details CV Safety Analysis of New Heart, Metabolic Drugs
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Draft Guidance Addresses Risk to Offspring of Father’s Drug Use
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CGT Early Trials Should Assess Possible Severe Effects: FDA
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FDA to Test Ability to Capture eHealth Data in Clinical Trials
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Social Media Fears Mean Lost Opportunity for Trial Sponsors
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FDA Draft Guidance Focuses On Development of DMD Drugs
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EMA Clarifies Endpoints for Adult, Pediatric Acute Heart Failure Trials
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House Passes 21st Century Cures Act, Companion Bill in Works in Senate
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CV Safety Analysis of New Metabolic Heart Drugs Focus of EMA Guideline
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