Regulatory perspectives of combination products

Combination products with a wide range of clinical applications represent a unique class of medical products that are composed of more than a singular medical device or drug/biological product. The product research and development, clinical translation as well as regulatory evaluation of combination...

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Autores principales:	Jiaxin Tian, Xu Song, Yongqing Wang, Maobo Cheng, Shuang Lu, Wei Xu, Guobiao Gao, Lei Sun, Zhonglan Tang, Minghui Wang, Xingdong Zhang
Formato:	article
Lenguaje:	EN
Publicado:	KeAi Communications Co., Ltd. 2022
Materias:	Combination products Definition Designation Safety and efficacy Regulatory science Materials of engineering and construction. Mechanics of materials TA401-492 Biology (General) QH301-705.5
Acceso en línea:	https://doaj.org/article/c6de51fe4402425a8ae255688e4d8ff0
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spelling	oai:doaj.org-article:c6de51fe4402425a8ae255688e4d8ff02021-11-30T04:16:46ZRegulatory perspectives of combination products2452-199X10.1016/j.bioactmat.2021.09.002https://doaj.org/article/c6de51fe4402425a8ae255688e4d8ff02022-04-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2452199X21004126https://doaj.org/toc/2452-199XCombination products with a wide range of clinical applications represent a unique class of medical products that are composed of more than a singular medical device or drug/biological product. The product research and development, clinical translation as well as regulatory evaluation of combination products are complex and challenging. This review firstly introduced the origin, definition and designation of combination products. Key areas of systematic regulatory review on the safety and efficacy of device-led/supervised combination products were then presented. Preclinical and clinical evaluation of combination products was discussed. Lastly, the research prospect of regulatory science for combination products was described. New tools of computational modeling and simulation, novel technologies such as artificial intelligence, needs of developing new standards, evidence-based research methods, new approaches including the designation of innovative or breakthrough medical products have been developed and could be used to assess the safety, efficacy, quality and performance of combination products. Taken together, the fast development of combination products with great potentials in healthcare provides new opportunities for the advancement of regulatory review as well as regulatory science.Jiaxin TianXu SongYongqing WangMaobo ChengShuang LuWei XuGuobiao GaoLei SunZhonglan TangMinghui WangXingdong ZhangKeAi Communications Co., Ltd.articleCombination productsDefinitionDesignationSafety and efficacyRegulatory scienceMaterials of engineering and construction. Mechanics of materialsTA401-492Biology (General)QH301-705.5ENBioactive Materials, Vol 10, Iss , Pp 492-503 (2022)
institution	DOAJ
collection	DOAJ
language	EN
topic	Combination products Definition Designation Safety and efficacy Regulatory science Materials of engineering and construction. Mechanics of materials TA401-492 Biology (General) QH301-705.5
spellingShingle	Combination products Definition Designation Safety and efficacy Regulatory science Materials of engineering and construction. Mechanics of materials TA401-492 Biology (General) QH301-705.5 Jiaxin Tian Xu Song Yongqing Wang Maobo Cheng Shuang Lu Wei Xu Guobiao Gao Lei Sun Zhonglan Tang Minghui Wang Xingdong Zhang Regulatory perspectives of combination products
description	Combination products with a wide range of clinical applications represent a unique class of medical products that are composed of more than a singular medical device or drug/biological product. The product research and development, clinical translation as well as regulatory evaluation of combination products are complex and challenging. This review firstly introduced the origin, definition and designation of combination products. Key areas of systematic regulatory review on the safety and efficacy of device-led/supervised combination products were then presented. Preclinical and clinical evaluation of combination products was discussed. Lastly, the research prospect of regulatory science for combination products was described. New tools of computational modeling and simulation, novel technologies such as artificial intelligence, needs of developing new standards, evidence-based research methods, new approaches including the designation of innovative or breakthrough medical products have been developed and could be used to assess the safety, efficacy, quality and performance of combination products. Taken together, the fast development of combination products with great potentials in healthcare provides new opportunities for the advancement of regulatory review as well as regulatory science.
format	article
author	Jiaxin Tian Xu Song Yongqing Wang Maobo Cheng Shuang Lu Wei Xu Guobiao Gao Lei Sun Zhonglan Tang Minghui Wang Xingdong Zhang
author_facet	Jiaxin Tian Xu Song Yongqing Wang Maobo Cheng Shuang Lu Wei Xu Guobiao Gao Lei Sun Zhonglan Tang Minghui Wang Xingdong Zhang
author_sort	Jiaxin Tian
title	Regulatory perspectives of combination products
title_short	Regulatory perspectives of combination products
title_full	Regulatory perspectives of combination products
title_fullStr	Regulatory perspectives of combination products
title_full_unstemmed	Regulatory perspectives of combination products
title_sort	regulatory perspectives of combination products
publisher	KeAi Communications Co., Ltd.
publishDate	2022
url	https://doaj.org/article/c6de51fe4402425a8ae255688e4d8ff0
work_keys_str_mv	AT jiaxintian regulatoryperspectivesofcombinationproducts AT xusong regulatoryperspectivesofcombinationproducts AT yongqingwang regulatoryperspectivesofcombinationproducts AT maobocheng regulatoryperspectivesofcombinationproducts AT shuanglu regulatoryperspectivesofcombinationproducts AT weixu regulatoryperspectivesofcombinationproducts AT guobiaogao regulatoryperspectivesofcombinationproducts AT leisun regulatoryperspectivesofcombinationproducts AT zhonglantang regulatoryperspectivesofcombinationproducts AT minghuiwang regulatoryperspectivesofcombinationproducts AT xingdongzhang regulatoryperspectivesofcombinationproducts
_version_	1718406830209630208

Regulatory perspectives of combination products

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