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To drive the development of advanced therapies, industry is asking the European Medicines Agency to provide further guidance, harmonize EU regulations and exercise flexibility. Read More
The European Medicines Agency is offering drugmakers new advice on when to update risk management plans for products with centralized marketing authorization. Read More
EMA is reviewing its guidelines for Phase 1 trials in the wake of a fatally flawed French study, with an eye toward issuing proposed revisions in July. Read More