Perspective: Communications with the Food and Drug Administration on the Development Pathway for a Cell-Based Therapy: Why, What, When, and How?
Perspective: Communications with the Food and Drug Administration on the Development Pathway for a Cell-Based Therapy: Why, What, When, and How?
复制标题
DOI：
10.5966/sctm.2012-0104
复制
发表时间：
2012-11-01
影响因子：
6
通讯作者：
Werner, Michael J.
中科院分区：
文献类型：
--
作者：
Feigal, Ellen G.;Tsokas, Katherine;Werner, Michael J.
关键利益相关者与美国食品药品监督管理局（FDA）之间的有效互动对于成功地引导监管流程并将新疗法推进临床试验至关重要。在开发基于细胞的疗法时尤其如此，这对证明安全性和有效性提出了独特的挑战。新细胞疗法的开发人员有许多机会通过正式和非正式的过程与监管机构互动。重要的是要了解如何最大限度地提高与FDA对话的效率，并制定有效的监管策略。本文概述了在整个监管过程中与FDA的互动类型。本文还指出了一些常见的陷阱，以避免和指导读者额外的参考资料和资源，以帮助通知细胞治疗研究人员和产品开发人员，并实现成功的监管互动。干细胞转化医学2012;1：825-832
Effective interaction between key stakeholders and the U.S. Food and Drug Administration (FDA) is central to successfully navigating the regulatory process and advancing new therapies into clinical trials. This is especially true when developing cell-based therapies, which pose unique challenges to demonstrating safety and effectiveness. There are numerous opportunities for developers of a new cell therapy to interact with the regulatory agency, through both formal and informal processes. It is important to understand how to maximize the productivity of dialogue with the FDA and develop an effective regulatory strategy. This article provides an overview of the types of interactions with the FDA that are available throughout the regulatory process. This article also notes some common pitfalls to avoid and directs readers to additional references and resources to help inform cell therapy researchers and product developers and enable successful regulatory interactions. STEM CELLS TRANSLATIONAL MEDICINE 2012;1:825-832