秒速赛车控制器

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FDA致力降低藥品成本,一項新的計劃將出臺
發布時間: 2019-12-23     來源:

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秒速赛车控制器TIYIGUIZEZHIDINGTONGZHIJIANGYUNXUGEZHOUHEMOUXIEQITAFEILIANBANGZHENGFUSHITIXIANGFDATIJIAOJINKOUJIHUATIAN,YIGONGQISHENCHAHEPIZHUN。JINKOUJIHUAKEYIYOUYAOJISHI、PIFASHANGHUOQITAZHOUHUOFEILIANBANGZHENGFUSHITIGONGTONGTIJIAO。ZHEXIEJIHUABEICHENGWEIDI804XIANGJINKOUJIHUA,YOUFDASHOUQUANGUANLIZAIJIANADAPIZHUNDEMOUXIECHUFANGYAODEJINKOU,QIEMANZUFDAPIZHUNDEYAOWUSHENQINGZHONGDETIAOJIAN。HEGEDECHUFANGYAOZAIJINKOUQIANBIXUZHONGXINTIESHANGMEIGUOGUIDINGDEBIAOQIAN,BINGJINXINGZHENSHIXING、JIANGJIEXINGCESHI,QUEBAOYAOPINFUHEJIDINGGUIFANHEBIAOZHUN。ZHIDEZHUYIDESHI,ZHEXIEXIANGMUHUANBIXUXIANGMEIGUOXIAOFEIZHEZHANSHIXIANZHUDECHENGBENXUEJIAN。

秒速赛车控制器CIWAI,MEIGUOZHENGFUHUANXUANBU,YIXIANGXINDEXINGYEZHINANCAOANYIJINGCHUTAI,GAICAOANMIAOSHULEYAOPINSHENGCHANSHANGWEICUJINCHUFANGYAO(BAOKUOSHENGWUZHIPIN)DEJINKOUERBIXUZUNXUNDECHENGXU,ZHEXIECHUFANGYAOSHIFDAPIZHUNDE、ZAIGUOWAISHENGCHANDE、SHOUQUANZAIQITARENHEGUOJIAXIAOSHOUDE,YIJIJIHUAZAIGAIGUOJIAXIAOSHOU。 

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秒速赛车控制器ERZHINANCAOANMIAOSHULEYAOPINZHIZAOSHANGTIJIAOWENJIANDECHENGXU,ZHENGMINGCONGRENHEWAIGUOJINKOUDECHANPINSHIJINGFDAPIZHUNDEYAOPIN,SHIANZHAOFDAPIZHUNDESHENQINGSHENGCHANDECHANPIN。ZHIDEZHUYIDESHI,GAIZHINANCAOANMIAOSHULEYAOPINSHENGCHANSHANGWEIHUODEFDAPIZHUNDEMOUXIECHUFANGYAO(BAOKUOSHENGWUZHIPIN)DEFUJIAGUOJIAYAOPINDAIMA(NDC)ERBIXUZUNXUNDECHENGXU,ZHEXIECHUFANGYAOZUICHUSHIZAIGUOWAISHENGCHANBINGDASUANZAIGUOWAIXIAOSHOUDE。SHIYONGEWAIDENDCJIANGYUNXUYAOWUGONGSIGENGLINGHUODITIGONGZHEXIECHANPINDEJIAGEDIYUMUQIANFENXIAOSHANGSUOYAOQIUDEJIAGE。

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提議規則通知部分原文:

Today, President Trump, along with the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration, issued a notice of proposed rulemaking (NPRM) that, if finalized, would allow for the importation of certain prescription drugs from Canada. In addition, the Administration is announcing the availability of a new draft guidance for industry that describes procedures drug manufacturers can follow to facilitate importation of prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country. 

The NPRM issued today is the first step in implementing a provision of federal law that would allow for the importation of certain prescription drugs from Canada under specific conditions that ensure the importation poses no additional risk to the public’s health and safety while achieving a significant reduction in the cost of covered products to the American consumer. The draft guidance issued today describes procedures for a drug manufacturer to submit documentation that demonstrates that the product offered for import from any foreign country is, in fact, an FDA-approved drug product, including that it is manufactured in accordance with the FDA-approved application.

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