Regulatory News

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EMA continues its efforts to facilitate early patient access to innovative medicines through initiation of PRIME schemeEMA continues its efforts to facilitate early patient access to innovative medicines through initiation of PRIME schemeEMA issues positive opinion to Amgen’s advanced therapy, Imlygic™ (T-Vec)EMA issues positive opinion to Amgen’s advanced therapy, Imlygic™ (T-Vec)EMA launches new patient registry initiative for collection of clinical dataEMA launches new patient registry initiative for collection of clinical dataCAT publishes Monthly Report for September 2015CAT publishes Monthly Report for September 2015US Guidance for Industry and FDA publications updateUS Guidance for Industry and FDA publications updateFDA issues Guidance for Industry on submissions for HLA testing kitsFDA issues Guidance for Industry on submissions for HLA testing kitsFDA issues final guidance on the design and analysis of shedding studiesFDA issues final guidance on the design and analysis of shedding studiesHTA provides statement on regulation of blood as a starting material for ATMPsHTA provides statement on regulation of blood as a starting material for ATMPsHTA announces workshops on updated codes of practiceHTA announces workshops on updated codes of practiceEMA releases addendum to ICH E6 guideline on good clinical practiceEMA releases addendum to ICH E6 guideline on good clinical practiceUK Cell Therapy GMP Manufacturing Capacity and Capability IncreasesUK Cell Therapy GMP Manufacturing Capacity and Capability IncreasesCollaboration to Improve Viral Vector Industrialisation ProcessCollaboration to Improve Viral Vector Industrialisation Process