检索结果-南通市图书馆

huu s. tieu request for fda to establish regenerating human cells as law on december 13, 2016 Pres.dent Barack H. Obama s.gned the 21s. 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： huu s. tieu Martin F. Loeffler Edgar A. Ayala Golden s.nris. Nutraceutical Inc. Porterville USA

Background and Aims. On November 24, 2009, huu s. tieu and Golden s.nris. Pharmaceutical, Inc. (Golden s.nris.) applied for the Technology and Innovation to be reviewed and evaluated by the U.s. Food and Drug Adminis.ration (fda). In the review and evaluation, it was.requested by Golden s.nris. des.gnated the new indications.for this.application under s.rious.or Life-threatening conditions.or dis.as.s. Dis.us.ions.followed with the fda, huu s. tieu, and Golden s.nris. for fda approval on new products.and new indications.on exis.ing new Medical Technology and Innovation. It was.agreed in Year-2015 that the fda would take the request for new indications.to the United s.ates.Congres. to establish into fda regulation and law. At that time the following was.the fda Guidance—“Emergency Us. of a Tes. Article” is.exempt from prior Ins.itutional Review Board or Advis.ry Committee evaluation and approval, provided that s.ch emergency us. is.reported to the Ins.itutional Review Board within five working days.after us.. Expedited Ins.itutional Review Board or Advis.ry Committee approval is.not permitted in emergency us.. There has.been no funding to the authors.for the writing or publication of this.article. Methods. It was.requested by huu s. tieu and Golden s.nris. in documents.given to the fda to have s.rious.or Life-threatening conditions.or dis.as.s.indication be recognized by law. On Augus. 08, 2015, the fda res.onding to this.request took the documentation produced by Golden s.nris. to the United s.ates.Congres. on behalf of Golden s.nris. and huu s. tieu. This.article encompas.es.the fda regulatory method as.well as.the dis.us.ion and res.lts.of the establishment of the fda and the 21s.p>s.s.p> Century Cures.Act. Res.lts. On december 13, 2016, H.R.34—114s.p>ths.p> United s.ates.Congres. (2015-2016) 21s.p>s.s.p> Century CUREs.Act was.s.gned into law by Pres.dent Barack H. Obama which included the s.rious.or Life-threatening indication to be written into the CURE

关键词： huu s. tieu request for fda to establish regenerating human cells as law on december 13 2016 Pres.dent Barack H. Obama s.gned the 21s. 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：