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    The Innovation Imperative for Biopharmaceutical Regulatory Science: Three Emerging Trends

    This article discusses how manufacturers' regulatory affairs functions could improve their conduct of regulatory science through adaptive pathways, joint scientific and health technology assessment advice and patient-centricity. The Innovation Imperative for Regulatory Science The US Food and Drug Administration (FDA) defines regulatory science as "the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance o...