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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Draft Guidance Addresses Risk to Offspring of Father’s Drug Use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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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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European Commission: Compulsory Licensing Up to Member States
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TGA to Be Graded on Regulatory Performance, Transparency
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Canada: New Rx Drug Labeling Requirements Take Effect
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More Guidance Needed on GMPs for Importers, EU Regulator Says
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EMA Updates Guideline on Advanced Therapies
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EMA Announces Early Interaction Meetings to Speed Meds for Kids
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