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EMA & EU

The European Medicines Agency, its committees (CHMP, PRAC), the European Commission, MDCG and EUDAMED.

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Guidance & Policy EMA Extends PV Inspections to Cover Subcontractors Sep 12, 20264 min read Read the story

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Drugs & Biologics EMA Reviews Injectable Iron Drugs Over Bone-Risk Reports Sep 11, 20264 min read Read the story

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Drugs & Biologics EU Approves GSK's Twice-Yearly Asthma Drug Exdensur Aug 25, 20265 min read Read the story

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Drugs & Biologics EU Clears Tecvayli Plus Daratumumab for Myeloma Aug 24, 20265 min read Read the story

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Drugs & Biologics CHMP Rejects Arimoclomol Again; Zevra Seeks Re-Examination Jul 27, 20266 min read Read the story

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Drugs & Biologics CHMP Backs the EU's First Refillable Eye Implant Jul 26, 20266 min read Read the story

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Guidance & Policy Brussels Says Only Manufacturers May Assign a Device's UDI Jul 24, 20265 min read Read the story

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Guidance & Policy EUDAMED's Next Deadline Is Narrower Than It Looks Jul 15, 20266 min read Read the story