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Regenerative Medicine Therapies for Rare Diseases

机译：稀有疾病的再生医学疗法

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摘要

The field of regenerative medicine is growing rapidly with the introduction of new therapies that have the potential to treat and cure serious medical conditions, including rare diseases, for which there are no available treatments. In the United States, the development of novel medical products is regulated and guided by the Food and Drug Administration (FDA). As scientific and technological advances are discovered and adopted by the medical industrial enterprise, the FDA’s implementation of policies that create a climate conducive to safe development and rapid availability of novel medical products is one of the pillars which support the Agency’s mission of protecting and promoting the public health. With advancements in cell modifications and tissue engineering, innovative creation of biomaterials, adoption of three-dimensional bioprinting, and rapid development of human genome editing technologies, the need for Agency’s work in ensuring that its science-based policies remain relevant and helpful in facilitating the availability of new treatments to the most vulnerable populations of patients becomes more pressing than ever before.
机译：随着新疗法的引入有可能治疗和治愈严重的医疗状况，包括罕见疾病，没有可用的治疗方法，再生医学领域正在迅速发展。在美国，新型医疗产品的开发受到食品药品监督管理局（FDA）的监管和指导。随着医学工业企业发现和采用科学和技术进步，FDA的实施政策创造了有利于安全开发和快速新型医疗产品的气候的政策，这是支持该机构的使命之一，该支柱是保护和促进该机构的使命。公共卫生。随着细胞修饰和组织工程的进步，生物材料的创新创建，采用三维生物构图以及人类基因组编辑技术的快速发展，因此需要代理机构在确保其基于科学的政策方面的工作，以确保其基于科学的政策和帮助促进促进对最脆弱的患者人群的新疗法的可用性比以往任何时候都更加紧迫。

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