Hellman K B
Center for Devices and Radiological Health, U.S. Food and Drug Administration, Rockville, Maryland 20852.
Tissue Eng. 1995 Summer;1(2):203-10. doi: 10.1089/ten.1995.1.203.
Novel emerging technologies such as tissue engineering, which utilize the approaches of molecular and cell biology, biotechnology, as well as materials science and engineering, are being used in the development of a wide range of biomedical products developed by industries regulated by the U.S. Food and Drug Administration (FDA). The FDA's mission is to promote and protect the public health by ensuring the safety and effectiveness of pharmaceuticals and medical devices, including those manufactured by novel technology, as assessed by scientific principles and methods. Regulatory review is conducted on a product-by-product basis. To accomplish its mission over the wide range of products in its regulatory purview, the FDA has six centers, each staffed with the scientific and regulatory expertise to evaluate the products in the center's jurisdiction. Recent legislative and regulatory changes are designed to simplify and facilitate the administrative process for evaluating novel combination products emanating from such interdisciplinary technology as tissue engineering and to resolve questions of product regulatory jurisdiction. Under the new procedures, the FDA may designate a lead FDA center for product review based on the primary mode of action of the combination product, with additional center(s) designated to assist in the evaluation in a collaborative or consultative capacity. In addition, FDA centers have increased their cooperation and information sharing with regard to evolving interdisciplinary technology. The FDA InterCenter Tissue Engineering Initiative was established to develop information on intercenter efforts in the evaluation of tissue engineering applications and to identify areas for further consideration. The FDA InterCenter Tissue Engineering Working Group, comprised of staff from the Center for Biologies Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation and Research (CDER), and Center for Veterinary Medicine (CVM) has developed a Draft Report considering recent developments in tissue engineering and scientific and regulatory issues in the product application areas. The Working Group has identified generic safety and effectiveness issues for consideration by the research and development community in its development of products. The FDA centers are using multiple approaches at their disposal in the evaluation of tissue engineered products including research, data and information monitoring, regulatory guidance, training and education, and cooperation with public and private groups.
新型的新兴技术，如组织工程学，它运用分子生物学、细胞生物学、生物技术以及材料科学与工程学的方法，正被用于开发由美国食品药品监督管理局（FDA）监管的各行业生产的广泛生物医学产品。FDA的使命是通过确保药品和医疗器械（包括那些采用新技术制造的产品）的安全性和有效性来促进和保护公众健康，这是依据科学原理和方法进行评估的。监管审查是逐产品进行的。为了在其监管范围内的广泛产品中完成使命，FDA设有六个中心，每个中心都配备有科学和监管专业知识，以评估该中心管辖范围内的产品。最近的立法和监管变革旨在简化和便利评估源自组织工程等跨学科技术的新型组合产品的行政程序，并解决产品监管管辖权问题。根据新程序，FDA可根据组合产品的主要作用方式指定一个牵头的FDA中心进行产品审查，并指定其他中心以协作或咨询的身份协助评估。此外，FDA各中心在不断发展的跨学科技术方面加强了合作与信息共享。成立了FDA跨中心组织工程倡议，以收集关于各中心在评估组织工程应用方面所做努力的信息，并确定需要进一步考虑的领域。由生物制品评估和研究中心（CBER）、器械和放射健康中心（CDRH）、药品评估和研究中心（CDER）以及兽医学中心（CVM）的工作人员组成的FDA跨中心组织工程工作组编写了一份报告草案，考虑了组织工程的最新发展以及产品应用领域的科学和监管问题。该工作组确定了一些通用的安全性和有效性问题，供研发界在产品开发过程中加以考虑。FDA各中心在评估组织工程产品时采用了多种可用方法，包括研究、数据和信息监测、监管指导、培训与教育以及与公共和私营团体的合作。
