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  • Regulatory NewsRegulatory News

    EMA Says Complying With its Scientific Advice Raises Likelihood of Approval, Fewer Objections

    A new study authored by European Medicines Agency (EMA) staff finds that companies that followed the agency's scientific advice are more likely to get their products authorized . Background EMA provides scientific advice to companies for a fee in order to assist them in designing clinical trials through its Scientific Advice Working Party (SAWP). If a clinical trial is not well designed, it can be difficult to for the agency to conduct an assessment of the product a...