FDA and NIST collaboration on standards development activities supporting innovation and translation of regenerative medicine products
FDA and NIST collaboration on standards development activities supporting innovation and translation of regenerative medicine products
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DOI：
10.1016/j.jcyt.2018.03.039
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发表时间：
2018-06-01
期刊：
影响因子：
4.5
通讯作者：
Lin-Gibson, Sheng
中科院分区：
文献类型：
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作者：
Arcidiacono, Judith A.;Bauer, Steven R.;Lin-Gibson, Sheng
若干路线图活动指出，制定再生医学领域的标准是一个高度优先事项。此外，美国国会认识到21世纪治疗法案中标准的重要性。标准将有助于加快和简化细胞和基因治疗产品的开发，确保过程和产品的质量和一致性，并促进其监管批准。虽然人们普遍同意需要为再生医学产品制定额外的标准，但为了在制定促进再生医学的标准方面取得真正进展，需要对标准有共同的理解。在这里，我们描述了标准在再生医学中的作用，以及标准制定的过程和不同实体在标准制定过程中的相互作用。重点介绍了美国食品和药物管理局和国家标准与技术研究所最近为促进标准制定和促进支撑标准制定的科学而做出的协调努力。
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.