کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
8466555 | 1549516 | 2018 | 6 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
FDA and NIST collaboration on standards development activities supporting innovation and translation of regenerative medicine products
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کلمات کلیدی
موضوعات مرتبط
علوم زیستی و بیوفناوری
بیوشیمی، ژنتیک و زیست شناسی مولکولی
بیولوژی سلول
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چکیده انگلیسی
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.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Cytotherapy - Volume 20, Issue 6, June 2018, Pages 779-784
Journal: Cytotherapy - Volume 20, Issue 6, June 2018, Pages 779-784
نویسندگان
Judith A. Arcidiacono, Steven R. Bauer, David S. Kaplan, Clare M. Allocca, Sumona Sarkar, Sheng Lin-Gibson,