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FDA and NIST collaboration on standards development activities supporting innovation and translation of regenerative medicine products

机译：FDA和NIST关于标准开发活动的合作，支持再生药品的创新和翻译

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The development of standards for the field of regenerative medicine has been noted as a high priority by several road-mapping activities. Additionally, the U.S. Congress recognizes the importance of standards in the 21st Century Cure Act. Standards will help to accelerate and streamline cell and gene therapy product development, ensure the quality and consistency of processes and products, and facilitate their regulatory approval. Although there is general agreement for the need of additional standards for regenerative medicine products, a shared understanding of standards is required for real progress toward the development of standards to advance regenerative medicine. Here, we describe the roles of standards in regenerative medicine as well as the process for standards development and the interactions of different entities in the standards development process. Highlighted are recent coordinated efforts between the U.S. Food and Drug Administration and the National Institute of Standards and Technology to facilitate standards development and foster science that underpins standards development.
机译：通过多种路法活动，已注意到再生医学领域标准的制定是高度优先事项。此外，美国国会认识到21世纪治疗法案的重要性。标准将有助于加速和精简细胞和基因治疗产品的开发，确保流程和产品的质量和一致性，并促进其监管批准。虽然有需要额外的再生药品标准的一般协议，但对推进再生医学的标准进行实际进展，需要对标准进行共同理解。在这里，我们描述了标准在再生医学中的作用以及标准开发过程以及标准开发过程中不同实体的相互作用。强调美国食品药品监督管理局与国家标准技术研究所之间的最近协调努力，以促进标准发展和促进标准发展的促进科学。

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