Regenerative medicine (“RM”) is a 21st century technology whose regulation has badly needed a 21st century cure. It is not clear that the 21st Century Cures Act (“Cures Act”) is that cure, but it has not been a poison. For some months prior to the passage of the Cures Act it seemed that it might be a catalyst for really endangering the field by allowing a flood of untested therapies to continue to enter the market. That, fortunately, did not happen. Thus far, the Cures Act has been a useful tonic; its effect on RM has been largely symbolic. But it has allowed the Food and Drug Administration (“FDA”) to redirect resources, and it demanded the quick adoption of guidance. That has allowed the Agency to finalize a regulatory framework that has been sorely needed. The evidentiary flexibility within the Cures Act is extremely important for the development of technologies that do not fit easily into the traditional approval rubric.

中文翻译：

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另一个名字的老鼠：21世纪治愈法案和干细胞疗法

再生医学（“RM”）是 21英石世纪技术，其监管急需 21英石世纪治愈。不清楚 21英石世纪治愈法（“治愈法”）就是那种治愈方法，但它不是毒药。在《治愈法案》通过之前的几个月里，它似乎可能成为真正危及该领域的催化剂，因为它允许大量未经测试的疗法继续进入市场。幸运的是，这并没有发生。到目前为止，《治愈法》一直是一种有用的补品；它对 RM 的影响在很大程度上是象征性的。但它允许美国食品和药物管理局（“FDA”）重新分配资源，并要求快速通过指导。这使该机构能够最终确定一个迫切需要的监管框架。《治愈法》中的证据灵活性对于开发不易符合传统批准标准的技术极为重要。