Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland 20852, USA.
Tissue Eng Part B Rev. 2010 Feb;16(1):41-54. doi: 10.1089/ten.TEB.2009.0449.
Tissue-engineered and regenerative medicine products are promising innovative therapies that can address unmet clinical needs. These products are often combinations of cells, scaffolds, and other factors and are complex in both structure and function. Their complexity introduces challenges for product developers to establish novel manufacturing and characterization techniques to ensure that these products are safe and effective prior to clinical trials in humans. Although there are only a few commercial products that are currently in the market, many more tissue-engineered and regenerative medicine products are under development. Therefore, it is the purpose of this article to help product developers in the early stages of product development by providing insight into the Food and Drug Administration (FDA) process and by highlighting some of the key scientific considerations that may be applicable to their products. We provide resources that are publically available from the FDA and others that are of potential interest. As the provided information is general in content, product developers should contact the FDA for feedback regarding their specific products. Also described are ways through which product developers can informally and formally interact with the FDA early in the development process to help in the efficient progression of products toward clinical trials.
组织工程和再生医学产品是很有前途的创新疗法，可以满足未满足的临床需求。这些产品通常是细胞、支架和其他因素的组合，在结构和功能上都很复杂。它们的复杂性给产品开发人员带来了挑战，需要建立新的制造和特性鉴定技术，以确保在人体临床试验之前，这些产品是安全有效的。虽然目前市场上只有少数几种商业产品，但还有更多的组织工程和再生医学产品正在开发中。因此，本文的目的是通过提供食品和药物管理局 (FDA) 流程的见解，并强调一些可能适用于其产品的关键科学考虑因素，来帮助产品开发人员在产品开发的早期阶段。我们提供了来自 FDA 和其他来源的公开可用资源，以及一些可能对他们的产品有潜在兴趣的资源。由于提供的信息内容较为笼统，产品开发人员应就其特定产品与 FDA 联系，以获取反馈。本文还介绍了产品开发人员如何在开发过程的早期与 FDA 进行非正式和正式的互动，以帮助产品高效地推进到临床试验阶段。
