检索结果-南通市图书馆

h.u S. TIEU Request for fda to Establish.Regenerating h.man Cells as law on December 13, 2016 president barack h. obama signed the 21st century cures act into fda regulation and law

引用

Open Journal of Regenerative Medicine 2022年第3期11卷 55-62页

作者： h.u S. Tieu Martin F. Loeffler Edgar A. Ayala Golden Sunrise Nutraceutical Inc. Porterville USA

Background and Aims: On November 24, 2009, h.u S. TIEU and Golden Sunrise Ph.rmaceutical, Inc. (Golden Sunrise) applied for th. Tech.ology and Innovation to be reviewed and evaluated by th. U.S. Food and Drug Administration (fda). In th. review and evaluation, it was requested by Golden Sunrise designated th. new indications for th.s application under Serious or Life-th.eatening conditions or diseases. Discussions followed with.th. fda, h.u S. TIEU, and Golden Sunrise for fda approval on new products and new indications on existing new Medical Tech.ology and Innovation. It was agreed in Year-2015 th.t th. fda would take th. request for new indications to th. United states Congress to establish.into fda regulation and law. At th.t time th. following was th. fda Guidance—“Emergency Use of a Test Article” is exempt from prior Institutional Review Board or Advisory Committee evaluation and approval, provided th.t such.emergency use is reported to th. Institutional Review Board with.n five working days after use. Expedited Institutional Review Board or Advisory Committee approval is not permitted in emergency use. Th.re h.s been no funding to th. auth.rs for th. writing or publication of th.s article. Meth.ds: It was requested by h.u S. TIEU and Golden Sunrise in documents given to th. fda to h.ve Serious or Life-th.eatening conditions or diseases indication be recognized by law. On August 08, 2015, th. fda responding to th.s request took th. documentation produced by Golden Sunrise to th. United states Congress on beh.lf of Golden Sunrise and h.u S. TIEU. Th.s article encompasses th. fda regulatory meth.d as well as th. discussion and results of th. establish.ent of th. fda and th. 21st century cures act. Results: On December 13, 2016, h.R.34—114th./sup> United states Congress (2015-2016) 21st century cures act was signed into law by president barack h. obama wh.ch.included th. Serious or Life-th.eatening indication to be written into th. CURE

关键词： h.u S. TIEU Request for fda to Establish.Regenerating h.man Cells as law on December 13 2016 president barack h. obama signed the 21st century cures act into fda regulation and law

来源：

维普期刊数据库评论

在线全文

维普期刊数据库

学校读者我要写书评

暂无评论

欢迎您,

建议与咨询留下您的常用邮箱和电话号码，以便我们向您反馈解决方案和替代方法

时间限定

文献类型

馆藏选择

核心期刊

语言

文献类型

帮助

文字说明：

检索规则说明：

检索范例：

分类表

所选分类

限定检索结果

文献类型

馆藏范围

日期分布

学科分类号

主题

机构

作者

语言

在线全文

请选择保存的检索档案：

请选择收藏分类：

通借通还

欢迎您,

建议与咨询 留下您的常用邮箱和电话号码，以便我们向您反馈解决方案和替代方法

时间限定

文献类型

馆藏选择

核心期刊

语言

文献类型

帮助

文字说明：

检索规则说明：

检索范例：

分类表

所选分类

限定检索结果

文献类型

馆藏范围

日期分布

学科分类号

主题

机构

作者

语言

在线全文

请选择保存的检索档案： 新增检索档案 确定 取消

请选择收藏分类： 新增自定义分类 确定 取消

通借通还

建议与咨询留下您的常用邮箱和电话号码，以便我们向您反馈解决方案和替代方法

请选择保存的检索档案：

请选择收藏分类：